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Abstract of thesis entitled

“Evidence-based Guidelines of Using Cryotherapy

in Reducing Pain, Knee Swelling and Improving

Range of Motion for Patients after Total Knee

Replacement”

Submitted by

Lui Pui Ling

for the degree of Master of Nursing at The University of Hong Kong

in July 2012

Introduction: Knee osteoarthritis is one of the common causes leading to

musculoskeletal disability of the elderly around the world. Total knee replacement

(TKR) is an effective and common treatment for end stage knee arthritis. Most

papers suggest that early rehabilitation could improve postoperative knee function.

However, postoperative pain and local swelling are the complications that

diminish range of motion (ROM) and inhibit patients’ recovery. A comprehensive

review of the literature reveals that cryotherapy is an effective and safe method to

overcome these complications. In this paper, a guideline of using cryotherapy in

reducing postoperative pain and knee swelling so as to improve the ROM of

patients and promote recovery after TKR has been developed.

Objectives: The objectives of this translational research are: (1) to look for

relevant papers that related to cryotherapy in reducing postoperative pain and

knee swelling so as to improve the ROM of patients after TKR; (2) to gather and

criticize the data obtained; (3) to develop a guideline of using cryotherapy in

reducing pain, knee swelling and improving ROM of patients after TKR based on

the evidence from the reviewed literature; (4) to assess the implementation

potential of the newly developed guidelines; and (5) to establish the

implementation and evaluation plans for the new innovation.

Methods: An empirical literature search published from 2001 to 2011 by several

searching engines regarding cryotherapy in reducing postoperative pain and knee

swelling with the aim to improve the ROM of patients after TKR has been

conducted. After that, the qualities of relevant studies were retrieved and

criticized by using the appraisal checklist of the SIGN (2004). The derived

evidences were then be summarized and synthesized. An evidence-based

guideline was established with reference to the evidence from the reviewed

literatures and the results of the quality assessment. Recommendations are graded

by SIGN (2004). The implementation potential including transferability,

feasibility and cost-benefit ratio of the innovation were assessed as well. Lastly,

implementation and evaluation plans have been developed to assess and appraise

the effectiveness of the new guideline.

Results: Finally, seven studies were chosen as final references after

methodological quality assessment. Four main types of comparison were made

from these seven reviews including: (1) continuous compressive cryotherapy vs.

compressive crepe bandage; (2) comparison in different temperature of

cryotherapy; (3) outcome measures; and (4) complications in cryotherapy. After

the summary, six main categories of recommendations were synthesized: (1)

continuous compression cryotherapy; (2) effective temperature; (3) potential

complications; (4) regular assessment; (5) duration; and (6) intermitted ice pack

regimen. Based on these syntheses and recommendations, a guideline of using

cryotherapy for patients after having TKR was developed.

Conclusion: With the implementation of the newly developed evidence-based

cryotherapy guidelines for patients after having TKR in local clinical settings, the

improvement in the ROM of the knee joint will be anticipated as a result of the

reduction in postoperative pain and knee swelling.

Evidence-based Guidelines of Using Cryotherapy in

Reducing Pain, Knee Swelling and Improving Range of

Motion for Patients after Total Knee Replacement

by

Lui Pui Ling

Bachelor of Nursing (Honors) H.K.U.

A thesis submitted in partial fulfillment of the requirements for

the Degree of Master of Nursing

at The University of Hong Kong

July 2012

Declaration

i

Declaration

I declare that the thesis and the research work thereof represents my own

work, except where due acknowledgement is made, and that it has not been

previously included in a thesis, dissertation or report submitted to this University

or to any other institution for a degree, diploma or other qualifications.

Signed ______________________________

Lui Pui Ling

Acknowledgements

ii

Acknowledgements

First of all, I owe my deepest gratitude to my thesis supervisor – Dr.

William Li. Without his encouragement, guidance and support in the preparation

and completion of this study, this dissertation would not have been possible.

Secondly, I would like to offer my heartily thankful to Dr. Daniel Fong and

Dr. Sharron Leung for their inputs and assistances in rendering tutorials and

comments.

Last but not the least, I offer my regards and blessings to my family, friends,

classmates and colleagues who supported me in any aspects throughout my study

of the Master Programme.

Contents

iii

Contents

Declaration i

Acknowledgements ii

Table of Contents iii

Lists of Appendices viii

Abbreviations ix

CHAPTER 1: INTRODUCTION

1.1 Background 1

1.2 Affirming Needs 3

1.3 Significance of the Study 4

1.4 Purpose of the Study 5

1.4.1 Research Questions 5

1.4.2 Objectives 5

1.4.3 Hypothesis 6

CHAPTER 2: CRITICAL APPRAISAL

2.1 Search Strategies 7

2.1.1 Study Selection Criteria 7

2.1.1.1 Inclusion Criteria 7

2.1.1.2 Exclusion Criteria 7

2.1.2 Searching Engines and Keywords Used 8

2.1.3 Extraction of Evidence 9

2.2 Appraisal Strategies 9

Contents

iv

2.3 Results 9

2.4 Summary and Synthesis of the Data 11

2.4.1 Data Summary 12

2.4.1.1 Continuous Compressive Cryotherapy vs.

Compressive Crepe Bandage

12

2.4.1.2 Continuous Cryotherapy vs. Intermitted

Cryotherapy

13

2.4.1.3 Cryotherapy vs. Epidural Anaesthesia 14

2.4.1.4 Comparison in Different Temperature of

Cryotherapy

15

2.4.1.5 Outcome Measures 16

2.4.1.6 Complications in Cryotherapy 17

2.4.2 Data Synthesis 17

2.4.2.1 Continuous Compression Cryotherapy 18

2.4.2.2 Effective Temperature 19

2.4.2.3 Potential Complications 20

2.4.2.4 Regular Assessment 20

2.4.2.5 Duration 21

2.4.2.6 Intermitted Ice Pack Regimen 22

2.4.2.7 Conclusion 22

CHAPTER 3: IMPLEMENTATION POTENTIAL

3.1 Target Settings and Audiences 23

3.1.1 Target Settings 23

3.1.2 Target Audiences 24

Contents

v

3.2 Transferability of the Findings 24

3.2.1 Proposed Setting 24

3.2.2 Proposed Audiences 25

3.2.3 Philosophy of Care 25

3.2.4 Popularity of the Innovation 27

3.2.5 Implementation and Evaluation Time 27

3.2.5.1 Implementation Time 27

3.2.5.2 Evaluation Time 28

3.3 Feasibility 29

3.3.1 Autonomy 29

3.3.2 Interfere Current Staff Functions 29

3.3.3 Support from Administration 30

3.3.4 Potential Barriers 30

3.3.5 Availabilities of Essential Equipments and Measuring Tools 32

3.4 Cost-Benefit Ratio of the Innovation 33

3.4.1 Potential Risks 33

3.4.2 Potential Benefits 33

3.4.3 Risks of Maintaining Current Practices 34

3.4.4 Cost for Implementation of New Protocol 34

3.4.4.1 Material Costs 34

3.4.4.2 Non-material Costs 35

3.4.5 Costs for Maintaining Current Practice 35

3.5 Conclusion 36

Contents

vi

CHAPTER 4: EVIDENCE BASED PRACTICE PROTOCOL

4.1 Background 37

4.2 Name of the Protocol 37

4.3 Objectives of the Protocol 37

4.4 Target Population of the Protocol 38

4.5 Rating System for the Recommendations 38

4.6 Practice Recommendations 39

4.7 Conclusion 45

CHAPTER 5: IMPLEMENTATION PLAN

5.1 Communication Plan 46

5.1.1 Identifying Stakeholders 46

5.1.2 Communication Plan with Stakeholders 47

5.1.2.1 Communication with Decision Makers 47

5.1.2.2 Communication with Project Team 48

5.1.2.3 Communication with Nurses in the Target Wards 51

5.1.2.4 Communication with Orthopaedic Doctors 52

5.1.2.5 Communication with Allied Health Professionals 52

5.2 Pilot Testing 53

5.2.1 Objectives 53

5.2.2 Target Setting and Target Population 53

5.2.3 Sampling Plan 54

5.2.4 Implementation 54

5.2.5 Outcomes to be Measured 55

5.2.6 Data Collection and Analysis 55

Contents

vii

5.2.7 Conclusion 56

CHAPTER 6: EVALUATION PLAN

6.1 Outcome to be Achieved 57

6.1.1 Primary Outcomes 57

6.1.2 Secondary Outcomes 59

6.2 Nature And Number Of Clients 61

6.2.1 The Nature of the Clients to be Involved 61

6.2.2 The Number of the Clients to be Involved 61

6.3 Time and Frequency of Taking Measurements 63

6.3.1 Primary Outcomes 64

6.3.2 Secondary Outcomes 64

6.4 Data Analysing Methods 65

6.5 Effectiveness of the Protocol 66

6.6 Conclusion 68

CHAPTER 7: SUMMARY 69

APPENDICES 70

REFERENCES 103

List of Appendices

viii

List of Appendices

Appendix 1: Table of Electronic Databases 70

Appendix 2: Tables of Evidences 72

Appendix 3: Levels of Evidences 79

Appendix 4: Grades of Recommendations 79

Appendix 5: Table of Critical Appraisals 80

Appendix 6: Summary of Levels of Evidences 95

Appendix 7: Criteria for Evaluating the Implementation Potential of an

Innovation under Scrutiny

96

Appendix 8: Cryotherapy Protocol Flow Chart 97

Appendix 9: Gannt Chart of Implementing the Protocol 98

Appendix 10: Pain Management Record Chart 99

Appendix 11: Knee Circumferences Record Chart 101

Appendix 12: Range of Motion Record Chart 102

Abbreviations

ix

Abbreviations

APN(s) Advance Practice Nurse(s)

BNI British Nursing Index

BNIA British Nursing Index and Archive

CB Compression Bandage

CINAHL Plus Cumulative Index of Nursing and Allied Health Literature

Plus

COS Chief of Service

CPM continuous passive motion devices

cryo cryotherapy

CT Cold Therapy

CTC Continuous temperature-controlled cryotherapy

D Postoperative Day

DOM Departmental Operational Manager

DVT deep vein thrombosis

EDA epidural anaesthesia

e.g. exempli gratia

etc. et cetera

Ev. evidence

F female

FPS-R Faces Pain Scale Revised

gp group

hr(s) hour(s)

IKDC International Knee Documentation Committee

kg kilogram

Lv. level

M male

mg milligram

min(s) minute(s)

Abbreviations

x

ml milliliter

mm millimeter

NCBI National Centre for Biotechnology Information

NO Nursing Officers

NRS Numerical Rating Scale

O&T Orthopaedics and Traumatology

OT operation

P level of significance

PCA patient controlled anaesthesia

post-op postoperative

pre-op preoperative

PT physiotherapist

RCT(s) randomized controlled trial(s)

ROM range of motion

SD standard derivation

SIGN Scottish Intercollegiate Guidelines Network

TKR total knee replacement

US United States

VAS Visual Analogue Scale

vs. versus

W / wk(s) Week(s)

WM Ward Manager

WOL Wiley Online Library

yr(s) old year(s) old

Chapter 1: Introduction

1

CHAPTER 1

INTRODUCTION

1.1 Background

Knee osteoarthritis is one of the common causes leading to musculoskeletal

disability of the elderly around the world. About 12% of the elderly aged over 65

in US as well as 15% of women and 6% of men in Beijing had symptomatic knee

osteoarthritis (Yan, Chiu, & Ng, 2011). Total knee replacement (TKR) is an

effective and common treatment for end stage knee arthritis. In the recent years,

the number of TKR performed each year is increasing rapidly in most developed

countries. The total number of TKR operations performed had increased by 150%

in the past decade in Australia (Lin et al., 2009) and increased by 69% from 1997

to 2005 in US (Yan, et al., 2011). According to Yan, et al. (2011), the annual

number of TKR operations performed had increased nearly double from 2000 to

2009 in Hong Kong. Moreover, Lin, et al. (2009) anticipated that the TKR

operations would continue to increase at least double in the following decade.

In view of the increasing number of TKR surgery, its complications

reported are also increased and become significance. There are numerous

complications reported from Coordinating Committee in Orthopaedics &

Traumatology (2011) including deep vein thrombosis, knee stiffness, wound or


2

chest infection, etc. Most studies proved that early mobilization or rehabilitation,

e.g. the use of CPM machine and postoperative exercise, could reduce the

postoperative complications (Brander & Stulberg, 2006; Pearse, Caldwell,

Lockwood, & Hollard, 2007) and improve the postoperative knee function

(Brander & Stulberg, 2006; Grella, 2008).

However, postoperative pain and local swelling are the great barriers that

inhibit patients’ recovery (Adie, Naylor, & Harris, 2010; Barry, Wallace, & Lamb,

2003). Some studies reported that the patients after operation would suffer from

acute and severe pain (Bonica, 1990; Crutchfield, Zimmerman, Nieveen,

Barnason, & Pozehl, 1996) as well as local swelling (Chou & Liu, 2008; Schroder

& Passler, 1994) during the early postoperative period and resulting in lowering

the motivation of the training adherence (Naylor, Harmer, Fransen, Crosbie, &

Innes, 2006). If the patients cannot participate in the training and perform the

activities of daily living after TKR, they cannot achieve the basic function of knee,

especially sitting on or getting out of a chair or sofa; going up or down stairs, etc.

Thus, their qualities of life would be affected. Finally, it will increase the

suffering of patient and affect the length of convalescence. In view of these,

adequate pain management and controlling localized swelling are necessary and

important.


3

1.2 Affirming Needs

Oral, intravenous or intramuscular analgesics are the common methods in

relieving postoperative pain for patients after TKR. However, most patients

reported dizziness and poor appetite which resulted from nausea and vomiting

after administrating the analgesics. Consequently, the wound healing progress will

be affected due to poor nutrition absorption. Also, patients will refuse

mobilization due to dizziness, as a result, slow down their rehabilitation.

Cryotherapy is one of the non-pharmacological methods to reduce the

traumatic or postoperative pain and swelling (Adie, et al., 2010). It is a therapy

that decreases the temperature of the skin surface by using ice bags or cold water

and applies on the injured tissues. The decreased the temperature of inner

structures (Martin, Spindler, Tarter, & Detwiler, 2002) and the conduction of

nerve signals (Abramson et al., 1966), the transmission of harmful signals and

inflammatory response will be suppressed (Matsen, Questad, & Matsen, 1975).

Consequently, the pain sensation and swelling will be reduced. In addition,

cryotherapy is a safe and economical way to manage the postoperative pain. Most

patients have positive comments in using cryotherapy (Lombardi, Drouillard,

Mallory, & Vaughn, 1993).

Cryotherapy is often used in early postoperative phase after orthopaedic


4

surgery in order to promote healing in British and Australia (Barry, et al., 2003;

Naylor, et al., 2006). However, it is not a common practice in other countries,

such as Hong Kong. In the proposed wards, it is not a routine practice to apply

cryotherapy for patients after TKR. Also, there is still controversial in the

advantages of this practice for the patients following TKR (Adie, et al., 2010).

Besides, the benefit of different interventions in cryotherapy is less justifiable, for

example, bandaging vs. cryotherapy, continuous vs. intermittence cryotherapy,

cryotherapy in acute phase vs. cryotherapy in whole recovery phase, the

effectiveness in different temperature of cryotherapy, etc. Moreover, as discussed

as above, the postoperative rehabilitation and range of motion (ROM) of knee are

associated with the effectiveness of postoperative pain management and knee

swelling. The consequence of poor pain control will affect the patients’ activities

of daily living and qualities of life after TKR. In consideration of the problems, a

study about the effectiveness of cryotherapy for patients after TKR in reducing

pain, knee swelling and promoting ROM of knee is important.

1.3 Significance of the Study

The pain and rehabilitation is in directed relationship: the poor pain control,

the lower motivation in rehabilitation. Thus, the patients’ activities of daily living

and qualities of life will be affected. As discussed, cryotherapy is a safe,


5

economic and effective practice compared with administrating analgesics alone.

In view of this, it seems that cryotherapy is one of the most feasible interventions

performed by nurses in reducing postoperative pain for patient with TKR. Based

on Melnyk and Fineout-Overholt (2005), the evidence-based practice would guide

to the highest quality of care. Therefore, the study of the effectiveness of

cryotherapy should be developed to improve practice for the patients’ best

interests.

1.4 Purpose of the Study

The purpose of the study is to evaluate the effectiveness of cryotherapy and

develop a cryotherapy protocol in reducing postoperative pain and knee swelling

for patients after TKR in order to improve the ROM of knee.

1.4.1 Research Questions

Is the cryotherapy effective in reducing postoperative pain, knee swelling

and improving the ROM of knee for patient after TKR?

1.4.2 Objectives

The objectives of this project are:

1. to gather the searched evidences on cryotherapy for patients after TKR.

2. to apply the findings and develop an evidence-based protocol on

cryotherapy in reducing postoperative pain and knee swelling for


6

patients after TKR.

3. to assess the feasibility of implementing the proposed protocol

4. to plan for the implementation of the protocol

5. to evaluate the effectiveness of the protocol in reducing pain and knee

swelling.

1.4.3 Hypothesis

The patients who receive the cryotherapy will share of having less pain

sensation verbally and less differences in bilateral knee circumference as well as

improving ROM of knee for patients after TKR.

Chapter 2: Critical Appraisal

7

CHAPTER 2

CRITICAL APPRAISAL

After affirming the needs and significances of the study in the previous

chapter, the following step is to search the relevant evidences as well as criticize

and synthesize the selected data. In this chapter, the searching strategies, its results,

appraisal strategies as well as the summary and the synthesis of the searched data

will be presented.

2.1 Search Strategies

2.1.1 Study Selection Criteria

2.1.1.1 Inclusion Criteria

This review would comprise the studies involving patients who had

performed knee surgeries, especially those with TKR. The studies about the

cryotherapy interventions in reducing postoperative pain and swelling would be

included as well. The interventions were able to implement by nurses in ward or

clinic settings. The studies which were published in English language, accessible

full text and the publication year after 2001 would also be included. Furthermore,

only controlled trials studies would be selected.

2.1.1.2 Exclusion Criteria

The studies which targeted on the postoperative treatment of other parts of


8

the body except knee would be excluded. The interventions which could not be

performed by nurses were also expelled. Moreover, the studies that were not

related in reducing pain and swelling of injured knee were ignored. This project

would reject the studies with participants who were disorientated or suffering

from psychiatric disorders as which could be a factor affecting the results.

2.1.2 Searching Engines and Keywords Used

Several electronic databases were used for the systematic search in this

paper, including MEDLINE via Ovid (1948 – 2011), British Nursing Index (BNI)

via Ovid (1994 – 2011), British Nursing Index and Archive (BNIA) via Ovid

(1985 – 2011), Cumulative Index of Nursing and Allied Health Literature Plus

(CINAHL Plus) via EBSCOhost, PubMed via National Centre for Biotechnology

Information (NCBI) and the Cochrane Library via Wiley Online Library (WOL).

An integrated search were applied through several attempts and

combinations with the use of keywords “total knee arthroplasty”, “total knee

replacement”, “cryotherapy”, “cold therapy” and “pain”. The related articles from

reference list of the selected studies were also assessed for suitability. The

searches were performed before 5th September 2011. Details of the database and

keywords used for searching are presented in Appendix 1.


9

2.1.3 Extraction of Evidence

The useful data would be extracted into tables by using the reference table

from “SIGN 50: A Guideline Developer's Handbook - Annex D: Completed

Evidence Table” of Scottish Intercollegiate Guidelines Network (2008) to develop

tables of evidences. The details of the table are listed in Appendix 2.

2.2 Appraisal Strategies

The “Controlled trial” critical appraisal tool in “SIGN 50: A Guideline

Developer's Handbook - Annex C: Critical appraisal - Notes and checklists” from

Scottish Intercollegiate Guidelines Network (2008) would be used to appraise the

quality of the identified paper. The details of the critical appraisal will be given in

Appendix 5.

The rating system for the hierarchy of evidence in “SIGN 50: A Guideline

Developer's Handbook - Annex B: Key to Evidence Statements and Grades of

Recommendations” from Scottish Intercollegiate Guidelines Network (2008) was

used to evaluate the level of evidence (see Appendix 3) and the grades of

recommendations (see Appendix 4).

2.3 Results

After matching with the above selection criterion, seven studies (see

Appendix 1) were chosen and analyzed in light of the table of evidence and


10

critical appraisal tool from Scottish Intercollegiate Guidelines Network (2008).

Five studies were selected by using MEDLINE via Ovid (1948 – 2011) (Gibbons,

Solan, Ricketts, & Patterson, 2001; Kullenberg, Ylipää, Söderlund, & Resch, 2006;

Morsi, 2002; Radkowski, et al., 2007; Smith, Stevens, Taylor, & Tibbey, 2002).

One study was identified in both British Nursing Index (BNI) via Ovid (1994 –

2011) and British Nursing Index and Archive (BNIA) via Ovid (1985 – 2011)

(Smith, et al., 2002). From Cumulative Index of Nursing and Allied Health

Literature Plus (CINAHL Plus) via EBSCOhost, one study was chosen (Smith, et

al., 2002). In PubMed via National Centre for Biotechnology Information (NCBI),

five studies were found (Holmström & Härdin, 2005; Kullenberg, et al., 2006;

Morsi, 2002; Radkowski, et al., 2007; Smith, et al., 2002). Finally, no study was

picked out from the Cochrane Library via Wiley Online Library (WOL).

Moreover, one study was discovered from the reference lists (Woolf, Barfield,

Merrill, & McBryde, 2008).

There was one prospective controlled trial (Morsi, 2002), whereas others

were randomized controlled trial (Gibbons, et al., 2001; Holmström & Härdin,

2005; Kullenberg, et al., 2006; Radkowski, et al., 2007; Smith, et al., 2002; Woolf,

et al., 2008). Among the six RCT studies, however, two of them did not clearly

stated the randomization and concealment method (Gibbons, et al., 2001;


11

Holmström & Härdin, 2005); two of them only stated the randomization method

(Smith, et al., 2002; Woolf, et al., 2008), while another study stated with

concealment method only (Kullenberg, et al., 2006).

All of target participants underwent TKR, except one paper which target

groups was those performed knee arthroscopy (Woolf, et al., 2008). Holmström &

Härdin (2005) had two experimental groups and one control groups, while the

remaining studies had one experimental group and one control group. The sample

size of the studies were ranged from 60 to 86.

The levels of evidence of seven selected studies were ranged from 1++ to

1 – and the summary is listed in Appendix 6. All the RCTs were rated at level 1

according to the definition of the levels of evidence in Appendix 3. One study was

rated as 1 – (Morsi, 2002), one study was rated as 1++ (Radkowski, et al., 2007)

and the remaining studies were rated as 1 + (Gibbons, et al., 2001; Holmström &

Härdin, 2005; Kullenberg, et al., 2006; Smith, et al., 2002; Woolf, et al., 2008).

2.4 Summary and Synthesis of the Data

According to the results of the tables of evidence, critical appraisals and the

levels of evidence from the identified articles, the summary and synthesis of data

will be shown in this paragraph.


12

2.4.1 Data Summary

Four main types of comparison could be categorized from these seven

papers and the details of the summary are listed as follow:

2.4.1.1 Continuous Compressive Cryotherapy vs. Compressive Crepe

Bandage (3 Studies)

Three studies, which purposes were to compare the differences between

continuous compressive cryotherapy and compressive crepe bandage in reducing

postoperative pain and ROM, were identified (Gibbons, et al., 2001; Morsi, 2002;

Smith, et al., 2002). From Gibbons, et al. (2001), the continuous compressive cold

therapy was applied to the intervention group by an inflated cryocuff that filled

with ice water to provide compression and cold therapy on the affected knee,

while, modified Robert Jones bandage with compression effect only was applied

to the control group. The subjective pain sensation was mild decreased and the

ROM of knee was a bit wider in the cold compression group. However, the results

were less statically significant. In Morsi (2002), both intervention and control

group were wrapped with compressive crepe bandage on the operation site. Only

extra cooling flow was applied in the intervention group. It suggested that the

continuous compressive cryotherapy had significant improvement in pain control

with less subjective pain score and analgesic used as well as ROM compared with


13

compressive crepe bandage. For Smith, et al. (2002), continuous cryotherapy was

applied in the first 24 hours after operation for the intervention group; on the other

hand, crepe bandage was kept intact for the control group in the first 24 hours. It

stated a bit decrease in swelling and more flexion in intervention group. The pain

score was similar in both intervention and control group in the first 24 hours. But

the results were less statically significant as well.

To sum up, all three studies revealed that continuous compressive

cryotherapy had greater benefits in reducing postoperative pain, swelling and

improving ROM of knee for patients after TKR although two studies (Morsi, 2002;

Smith, et al., 2002) with less statically significant. Moreover, no complication

such as adverse effect on wound healing was exposed in these three studies.

2.4.1.2 Continuous Cryotherapy vs. Intermitted Cryotherapy (1 Study)

A study was distinguished to compare the difference between continuous

cryotherapy and intermitted cryotherapy (Woolf, et al., 2008). The researchers set

the continuous cryotherapy machine for patient in intervention group. For control

group, the patient was applied ice bag with compressive dressing for 20 minutes

in every two hours at daytime. It showed the continuous cryotherapy was better in

pain control than intermitted ice pack regimen at first two postoperative days.

Besides, the patients had less pain at night time significantly. However, in latter


14

postoperative period, the participants told that intermitted ice pack regimen has a

bit lower pain sensation than continuous cryotherapy.

Overall, continuous cryotherapy had better pain control, especially during

night time, than intermitted ice pack regimen in the early postoperative stage after

knee surgery. Also, it was a safe procedure without developing thermal skin injury,

nerve palsy or infection in the study.

2.4.1.3 Cryotherapy vs. Epidural Anaesthesia (2 Studies)

Two studies compared the differences between cryotherapy and epidural

anaesthesia (Holmström & Härdin, 2005; Kullenberg, et al., 2006). There were

three experimental groups in Holmström & Härdin (2005) study. They suggested

using cryocuff to provide cold therapy for one of the experimental groups and

continuous epidural anaesthesia infusion for another experimental group. Also, a

control group with traditional analgesics only was introduced to compare with the

two experimental groups. The results inferred that no significant different

observed about subjective pain scores at rest or on motion in the three groups.

However, there was significantly decrease in the used of morphine in both

continuous cryotherapy and epidural anaesthesia which compared to the control

group. Also, it revealed that the patients in cryotherapy group decrease morphine

consumption constantly even after discontinuous the cryotherapy and no


15

morphine was requested after postoperative day 4, while the other group

consumed morphine continuously until postoperative day 7. There was a bit

reduced in knee swelling for patients in the cryotherapy group. But no significant

different observed in passive or active ROM in all three groups of participants.

Kullenberg, et al. (2006) compared the variation between cold compression

therapy and epidural analgesia therapy. The cyrocuff was applied for patients in

the intervention group and the epidural analgesia was used in the comparsion

group. The patients had less pain sensation and morphine consumption in the cold

compression group. Moreover, the ROM improved significantly in the cold

compression group.

In short, both studies said that the cryotherapy had better advantages in pain

controls which used less analgesic than epidural anaesthesia. One study

(Kullenberg, et al., 2006) believed cryotherapy would improved the ROM and

shorten the rehabilitation period, whereas, another study (Holmström & Härdin,

2005) showed less differences in knee swelling and ROM between the two

groups.

2.4.1.4 Comparison in Different Temperature of Cryotherapy (1

Study)

Only one study (Radkowski, et al., 2007) verified the effectiveness in


16

different temperature of cryotherapy. The researchers set the temperature of

cryocuff at 45°F in intervention group and at 75°F in the comparison group. The

results reported that there were no significant differences or improvement of

patients with colder temperature cryotherapy devices in pain sensation, opioid

consumption and ROM.

2.4.1.5 Outcome Measures (All Studies)

All studies using similar visual analogue pain scale with variable range to

measure the subjective pain sensation, including 0 – 100 (Gibbons, et al., 2001),

0 – 10 (Holmström & Härdin, 2005; Radkowski, et al., 2007), 1 – 10 (Morsi, 2002;

Smith, et al., 2002) and 5-point scale (Woolf, et al., 2008), while one study did not

stated its range clearly (Kullenberg, et al., 2006).

For knee swelling, two studies had dabbled in this category. One study

described the measurement method in details (Holmström & Härdin, 2005),

whereas another study only stated to measure the swelling by physiotherapists at

the same time for three days from pre-operation to day 2 (Smith, et al., 2002).

For range of motion, there were five studies which looked into this aspect.

One study illustrated the measurement method in details (Holmström & Härdin,

2005), whereas others studies just presented with measuring time or measurement

tools briefly (Kullenberg, et al., 2006; Morsi, 2002; Radkowski, et al., 2007;


17

Smith, et al., 2002).

2.4.1.6 Complications in Cryotherapy (6 Studies)

Six studies had reported about the complication of cryotherapy in their

papers (Gibbons, et al., 2001; Holmström & Härdin, 2005; Kullenberg, et al.,

2006; Morsi, 2002; Radkowski, et al., 2007; Woolf, et al., 2008). Among these

researches, four studies reported there was no cryotherapy-related complication

observed (Gibbons, et al., 2001; Morsi, 2002; Radkowski, et al., 2007; Woolf, et

al., 2008). From Holmström & Härdin (2005), they mentioned that one patient

requested to take off the cryocuff during the expirmental period and one patient

had cold sensation but continue the procedure. Kullenberg, et al. (2006) told there

was one patient with deep vein thrombosis and one patient with superficial

infection of unknown reason in the cryotherapy group. Overally, cryotherapy was

a harmless treatment which compared with other analgesics especially epidural

anaesthesia.

In conclude, cryotherapy was a safe and effective procedure in reducing

postoperative pain, swelling and improving ROM of knee for patients after TKR.

2.4.2 Data Synthesis

After extracting and summarizing the data, cryotherapy seemed to be

recommended for patient after TKR. In this part, the evidences in previous


18

paragraph are synthesized and presented as follow to maximize the benefit of

cryotherapy:

2.4.2.1 Continuous Compression Cryotherapy

Three studies used cryocuff as a means to provide cryotherapy for the

patients in the intervention groups (Gibbons, et al., 2001; Holmström & Härdin,

2005; Kullenberg, et al., 2006). Cryocuff was a device with an inflated cuff that

consisted of cold and compression effects at the same time. Among these three

studies, two studies proved cryotherapy with cryocuff had significantly decreased

in the use of analgesics and postoperative swelling as well as improved ROM for

patient with TKR (Holmström & Härdin, 2005; Kullenberg, et al., 2006), whereas

another study showed little improvement in pain control and ROM. Comparing

with Morsi (2002), the researcher used two bottles which connected with a plastic

tube and coiled around the affected knee. The cold therapy was given from the

cold water in a bottle which hanged at higher level to a lower empty bottle via the

coiled plastic tube. To sustain the cryotherapy, the two bottles needed to change

frequently. This research proved continuous cryotherapy was beneficial to the

patients with TKR as well. Among these studies, cryocuff was recommended to be

the device for continuous compressive cryotherapy comparatively. Not only the

proven advantages in pain control and reduced postoperative swelling, but also


19

less labour involved in managing the cold treatment. Ice water was just needed to

change when it melted. Some cryocuff instruments even could maintain the

required temperature and it saved extra manpower to manage the system.

2.4.2.2 Effective Temperature

Four studies had mentioned about temperature used of cryotherapy in their

studies (Holmström & Härdin, 2005; Morsi, 2002; Radkowski, et al., 2007; Smith,

et al., 2002). Holmström & Härdin (2005) tried 10°C to 15°C cold therapy in their

study. Morsi (2002) kept the skin temperature at 7°C ±2°C for two hours after

surgery and then kept at 12°C±3°C in the remaining time. Smith, et al. (2002) set

the cryotherapy machine at 2°C to 5°C in their experiment. One of the studies

even compared two different temperatures (45°F and 75°F) in the research

(Radkowski, et al., 2007). From the above studies, two studies showed the

cryotherapy with temperature from 7°C to 15°C had significant advantages on

pain control and ROM (Holmström & Härdin, 2005; Morsi, 2002). However,

Radkowski, et al., (2007) believed that there was no great difference of

cryotherapy with warmer or cooler temperature. Moreover, a study warned that

low temperature may increase the risk of tissue damage (Farry, Prentice, Hunter,

& Wakelin, 1980). Thus, to balance the pros and cons, cryotherapy which kept at

12°C to 15°C would be suggested and regular checking should be implemented to


20

prevent complications.

2.4.2.3 Potential Complications

Five studies raised the potential complications that would occur for patients

with cryotherapy (Kullenberg, et al., 2006; Morsi, 2002; Radkowski, et al., 2007;

Smith, et al., 2002; Woolf, et al., 2008). Kullenberg, et al., (2006) revealed one

patient in the cryotherapy group suffered from deep vein thrombosis whereas the

remaining studies did not discover any complications from the researches.

However, the studies had mentioned about the potential complication in their

studies, including discomfort feelings (Smith, et al., 2002), frostbite (Morsi, 2002;

Woolf, et al., 2008), nerve palsy (Morsi, 2002; Radkowski, et al., 2007; Woolf, et

al., 2008), wound dehiscence (Radkowski, et al., 2007), infection (Woolf, et al.,

2008), blisters (Smith, et al., 2002) and compartment syndrome (Smith, et al.,

2002). Therefore, regular assessment was highly recommended to prevent the

undesired complications.

2.4.2.4 Regular Assessment

Nurses would approach the patients regularly to re-chill the device or

change ice water for the reason of maintaining the cryotherapy in two researches

(Holmström & Härdin, 2005; Kullenberg, et al., 2006). Holmström & Härdin

(2005) recommended nurses should approach the patients every six hours or more


21

often in order to change the ice water and assess the patients for any discomfort.

Kullenberg, et al. (2006) just suggested nurses should encounter the patients for

re-chilling the device every 60 minutes and changing ice water every four hours

with checking of any complications. Combining these two suggestions, regular

assessment of complications and patients’ discomfort every four hours minimally

would be proposed in order to minimize the nurses’ workload and prevent the

unwanted complications.

2.4.2.5 Duration

All studies had discussed about the suitable length of applying cryotherapy

(Gibbons, et al., 2001; Holmström & Härdin, 2005; Kullenberg, et al., 2006;

Morsi, 2002; Radkowski, et al., 2007; Smith, et al., 2002; Woolf, et al., 2008).

However, different studies suggested different durations. Gibbons, et at., (2001)

thought the cryocuff should be placed at least six hours during the daytime until

discharge. Holmström & Härdin (2005) believed the cold therapy should be

continued for 48 hours. Kullenberg, et al. (2006) said the cryotherapy should be

applied for three days. Morsi (2002) instructed to coil the continuous cooling

device for six days. Radkowski, et al., (2007) advised to continue the cryotherapy

upon discharge. Smith, et al., (2002) told the cryo treatment should be performed

for the first 24 hours and then followed by intermitted ice pack regimen for the


22

next 24 to 48 hours. Woolf, et al. (2008) recommended to wrap the cryocuff for

minimum four days. Moreover, they proved that continuous cryotherapy had

better pain control, especially during night time, on the second postoperative day.

After synthesizing the advices and considering the manpower required, the

continuous cryotherapy would be suggested at the first 48 hours for patients with

TKR.

2.4.2.6 Intermitted Ice Pack Regimen

Two studies used intermitted ice pack regimen in their researches (Smith, et

al., 2002; Woolf, et al., 2008). Smith, et al., (2002) suggested to apply ice pack in

plastics bag and wrapped with a towel three times a day for 15 minutes. Woolf, et

al., (2008) proposed to provide ice pack with compressive dressing for 20 minutes

every two hours. In view of the advantages of cold therapy and labour intensive,

ice pack regimen was advised to be given four times per day for 20 minutes after

ceasing the continuous cryotherapy machine.

2.4.2.7 Conclusion

To sum up, cryotherapy, whatever continuous or intermitted, had benefits

for patients with TKR in reducing postoperative pain, swelling and improve

postoperative ROM. Therefore, developing a cryotherapy protocol for patients

after TKR is necessary.

Chapter 3: Implementation Potential

23

CHAPTER 3

IMPLEMENTATION POTENTIAL

As talked in the previous chapters, TKR is a common orthopaedic surgery

in Hong Kong. Thus, the complications (e.g. postoperative pain, knee swelling

and ROM, etc.) after the surgery cannot be neglected. In view of this, it is

essential to develop an evidence-based protocol. However, before this can be

achieved, the implementation potential of the innovation should be evaluated.

Therefore, in this chapter, the implementation potential of the innovations

including transferability of the findings, feasibility and the cost-benefit ratio of the

innovation, which based on the criteria discussed by Polit & Beck (2008), will be

assessed and presented (see Appendix 7).

3.1 Target Settings and Audiences

The target settings and audiences should be identified at the beginning.

3.1.1 Target Settings

The target settings are the orthopaedics and traumatology (O&T) wards of a

public hospital from Hospital Authority. There are two O&T wards in this hospital,

one is a male ward and another is female ward. Each ward has 42 beds and serves

about 200 patients with TKR performed annually. The average length of stay in

hospital is about 12 – 16 days.


24

3.1.2 Target Audiences

The target audiences are the patients who have undergone TKR in the target

wards, except those who have contraindication to cryotherapy such as circulatory

insufficiency (e.g. peripheral vascular disease), cold allergy (e.g. cold urticaria),

cutaneous sensory abnormalities, cryoglobulinemia, Raynaud’s phenomenon,

haemoglobinopathy and advanced diabetes, etc (Chatap, De Sousa, Giraud, &

Vincent, 2007; Nadler, Weingand, & Kruse, 2004). Furthermore, they should be

cognitive intact to follow the instructions and willing to apply the cryotherapy at

the postoperative stages after explanation.

All the nurses in the target wards are responsible for applying the

cryotherapy. They should understand the protocol thoroughly before delivering it.

Therefore, they should receive some training before delivering the interventions.

3.2 Transferability of the Findings

3.2.1 Proposed Setting

Although all the previous studies did not mention the target settings and the

conduction places, the entire target populations of the researches were performed

knee surgeries which usually took place in O&T wards. Therefore, the innovation

can be transferred to the proposed settings.


25

3.2.2 Proposed Audiences

The subjects of the previous studies were similar to the proposed audiences.

The participants of five studies were undergone TKR (Gibbons, et al., 2001;

Kullenberg, et al., 2006; Morsi, 2002; Radkowski, et al., 2007; Smith, et al., 2002)

whereas the samples of one study was performed unicompartmental knee

arthroplasty (Holmström & Härdin, 2005) and the remained one was performed

knee arthroscopy (Woolf, et al., 2008). Also, the age of the reviewed studies was

around 63 to 72 years old, which was similar to the age of the target audiences

who generally aged over 60 years old. Moreover, the responsible staffs of

previous studies were also similar to the proposed settings as well. Three studies

presented that nurses were responsible staff (Holmström & Härdin, 2005;

Kullenberg, et al., 2006; Radkowski, et al., 2007) whereas two studies reported

that the physiotherapists were responsible for the interventions (Gibbons, et al.,

2001; Radkowski, et al., 2007).

To sum up, the populations involved are similar to the proposed audiences

and therefore the findings can be transferable.

3.2.3 Philosophy of Care

There are numerous philosophies of cares underlying the innovation which

are similar to the proposed setting.


26

The innovation proposed is evidence-based which will improve the quality

of nursing care and enhance the professional image. Medical Service

Development Committee of Hospital Authority (2002) encourages the use of

clinical practice guideline which has the potential to align clinical practice to

scientific evidence. Hospital Authority (2002) also promotes high quality patient

care by striving for the highest standard of nursing practice. It supports the staff to

make clinical decision basing on evidence-based research. It will create an

environment with and for staff to enhance their potential as well.

The second philosophy of care of the innovation is to help the patients

relieve the undesired pain sensations after surgery. Hospital Authority (2002)

suggests the role of O&T nurses should identify and treat the acute and chronic

pain which frequently occur in the orthopaedic population.

The third philosophy of care of the innovation is to enhance the quality of

patient-centred services in order to improve the quality of life. The core value of

Hospital Authority is to provide quality patient-centred care through teamwork.

Hospital Authority (2002) believes that O&T nurses should provide

individualized and high quality nursing care for all clients and their families.

Lastly, the innovation proffers to provide cost-effective and safe nursing

practice to patients. Hospital Authority (2002) bolsters the O&T nurses to provide


27

cost-effective nursing care to patients. Hospital Authority (2010) also encourages

promoting continuously service quality and safety.

In sum, the philosophy of care underlying the innovation is similar to the

philosophy prevailing in the proposed setting, and thus the findings of the

previous studies can be transferable.

3.2.4 Popularity of the Innovation

As discussed before, the target settings serve about 200 patients to undergo

TKR in each ward every year. There are two O&T wards in this hospital. Hence,

the total number of the patients who benefit from the innovation will be about 300

patients annually. There is sufficiently large number of clients to get the

advantages from the new protocol.

3.2.5 Implementation and Evaluation Time

3.2.5.1 Implementation Time

The first step of starting the evidence-based protocol is to get the approval

and support from the decision makers. The Chief of Service, General Manager

(Nursing), Departmental Operational Manager, Ward Manager and Nursing

Officers or Advance Practice Nurses should be communicated as well as to get

their approval and support before. It takes around two days to discuss with them.

The cooperation of orthopaedic doctors and allied health professionals are also


28

important. After that, it needs about two months to develop this guideline by the

project coordinator. Time of preparing equipments (e.g. goniometer,

documentation charts, etc.) have to be counted as well. For the cryocuff and ice

maker which are already in wards, no extra time is required to prepare. Finally, it

requires about six to eight sessions to introduce the new protocol to the nurses in

the proposed settings which consumes about one to two week. Five to six nurses

will be attended in each training session. The duration of each session lasts for

about one to two hours.

3.2.5.2 Evaluation Time

The outcomes can be evaluated into three aspects. For the impact evaluation,

the attitudes, skills and understandings of the new protocol can be measured. It is

a short term evaluation. The perception and competency of implementing the new

protocol will be assessed after the introduction sessions by questioning staff in

question and answer session and getting verbal feedback from staff. For the

process evaluation, the utility of the proposed protocol and its quality will be

monitored. It is a long term evaluation which assures the staff putting the protocol

into practice efficiently and effectively as planned via regular review and

feedback from colleagues. For the outcome evaluation, the differences of pain

sensation, knee swelling and its ROM after implementing the protocol will be


29

checked. It is a long term evaluation. Pain sensation will be assessed regularly for

patients with standard pain assessment tools used in ward during their length of

stay; the knee swelling should be recorded regularly by measuring the knee

circumferences and the ROM of knee will be checked regularly by using

goniometer.

3.3 Feasibility

3.3.1 Autonomy

According to Hospital Authority (2002), nurses can make clinical decision

basing on nursing process, theory, research and specific orthopaedics knowledge.

Moreover, cryotherapy is a non-pharmacological procedure and safe practice

which is allowed to use by clinical judgement of nurses in the target setting. In

view of this, the nurses will have freedom to carry out and terminate the

innovation by their knowledge and judgement.

3.3.2 Interfere Current Staff Functions

As talked before, nurses have the autonomy to apply cryotherapy by their

clinical decision. Moreover, the cryocuff is applied after operation immediately in

the operation theatre. Therefore, the nurses are required regular assessment in

each shift only. During these times, they could assess the signs of complication

and the pain intensity of the patients as well as maintain the temperature of the


30

cooler. For these reasons, the implementation of the innovation will not interfere

with the current staff functions.

3.3.3 Support from Administration

Hospital Authority supports clinical practice guideline to align clinical

practice with scientific evidence in local health care settings (MSDC, HA, 2002)

as well as create an environment with and for staff to enhance their potential. The

mission of the target hospital is “to provide a level of care and services good

enough for our own patients”, thus it supports good practices to improve the

quality of health care services. The orthopaedics department also advocates

individualized, high quality and cost-effective nursing care to all patients (HA,

2002). Furthermore, the wards are welcome evidence-based practice to improve

the quality of nursing. The staff can discuss concerns, share opinion and conclude

new workable procedure in the regular staff meeting. As a whole, the

administrations involved support the innovation.

3.3.4 Potential Barriers

There may be some potential barriers in implementing the innovation by

several parties. Firstly, approval and support from the decision makers, e.g. COS,

DOM, WM, NO and APN, ought to be obtained. The protocol cannot be

implemented if they turn down. The proposal including significances of pain


31

management and effectiveness of cryotherapy with evidence support as well as

the advantages of changes such as reducing the length of stay, feasibility and

cost-effectiveness with a budget plan will be presented in the meeting and

persuade their support.

Next, the nurses who are responsible for the programme in the ward should

be informed for the details of the protocol. The compliance and acceptance of the

nurses are important in the success of implementation of the protocol. However,

most people are not willing to change the usual practice and adopt another new

protocol, besides, it benefit themselves and other people. Hence, advantages of

implementing new protocols, e.g. reducing the length of stay and increasing

professional image as well as clarification of misunderstand and uncertainties of

the protocol should be explained to the staff in advance in order to enhance their

acceptances and interests. Moreover, the skill of applying cryotherapy is ought to

be taught to new staff for promoting the compliance.

Then, the cooperation of orthopaedic doctors is also important as they are

responsible for applying the cryocuff after operation, prescribing the medications

and the post operation treatments for the patients. The responsible staff will

explain the details of the protocol and implementation strategies to the

orthopaedic doctors in their weekly meeting with a question and answer session to


32

explain and clarify their concerns in order to invite their participance as well as

enhance their acceptances and cooperation.

Also, the allied health professionals such as physiotherapists and

occupational therapists are another leading factor in successful protocol

implementation. They play important roles in rehabilitation of patients after

surgery. Therefore, the cooperation of them is another hit to increase the

compliance of the protocol of the patients. The responsible staff will also explain

the details of the protocol and the implementation strategies to the allied health

professionals in their weekly meeting with a question and answer session to

explain and clarify their concerns in order to invite their participance as well as

enhance their acceptances and cooperation.

Except these, there are other unpredictable barriers which cannot be

identified previously. For the sake of preventing them, a pilot study is worth to

perform before the implementation. The pilot study will reveal the actual and

concrete problems or barriers in implementation of the proposed evidence-based

practice.

3.3.5 Availabilities of Essential Equipments and Measuring Tools

Although nearly all necessary instruments including cryocuff with

temperature control, ice maker, plastics bags, tape water and electricity are


33

available in the ward, it is not a practice to apply cryotherapy after TKR in the

target setting. Therefore, it is worth to develop the new protocol in order to

increase the quality of nursing care. Besides, the measuring tools, e.g. pain score

assessment tools and measuring tools except goniometer, the knee circumferences

and ROM record charts are used in wards already as well.

3.4 Cost-Benefit Ratio of the Innovation

3.4.1 Potential Risks

The major potential risk of using cryotherapy is cold related complication

development, like intolerant cold sensation, frostbite, transient nerve palsy, wound

dehiscence and deep vein thrombosis. From the studies, the complication is rare.

Only two patients complaint of intolerant cold sensation and one patient develop

deep vein thrombosis (Gibbons, et al., 2001; Holmström & Härdin, 2005;

Kullenberg, et al., 2006; Morsi, 2002; Radkowski, et al., 2007; Smith, et al., 2002;

Woolf, et al., 2008). Most complication like intolerant cold sensation, frostbite or

transient nerve palsy can be relieved after stopping the cryotherapy. For wound

dehiscence, sufficient nutrition support can promote wound healing. For the DVT,

adequate limbs exercise can prevent it development.

3.4.2 Potential Benefits

Despite of the potential risks, there are some potential benefits of the


34

innovation. For the patients, the decreasing of pain sensation and swelling will

promote their rehabilitation and reduce the complication. Hence, their quality of

life can be improved. For the health care providers, their professional image and

knowledge will be increased as well as decrease the length of stay and

complication development. As a result, their workload can be reduced. For the

hospital, the medical cost can be cut down because cryotherapy is a safe and

economical practice. Also, the length of stay and complication development will

be reduced. So, the medical cost can further be saved.

3.4.3 Risks of Maintaining Current Practices

If the current practice is still maintained, the consumption of other means of

pain control such as PCA, oral or injected painkillers might be increased.

Consequently, the side effects of drugs and their risks will be increased and the

rehabilitation will be affected. The less rehabilitation, the more length of stay and

complication developed. Finally, the medical cost and workload of staff will be

increased and the patients’ quality of life will be diminished.

3.4.4 Costs for Implementation of New Protocol

3.4.4.1 Material Costs

As discussed, nearly all the necessary equipments such as cryocuff with

temperature control, knee cuff, ice maker, plastic bags, tape water and electricity


35

as well as evaluation measuring tools such as pain score assessment tools and

measuring tools except goniometer, the knee circumferences and ROM record

charts are available in ward . Therefore, not much extra time and budget are

needed to implement the innovation.

3.4.4.2 Non-material Costs

Besides, manpower is another cost that has to be considered. All nurses in

the proposed settings are responsible for running the programme. Although the

cryocuff is applied in the operation theatre by surgeons, the nurses still have to

assess the patients for tolerableness of cryotherapy and complication development

as well as check the proper operation of the cryocuff and re-chill the cryocuff to

maintain the temperature regularly. The nurses should spend extra time on

implementing the new protocol. However, the nurses need to examine patient

regularly in their daily work. So, the staff can make use of these times to look

over the pain intensity, signs of complication, tolerableness of cryotherapy of the

patients and maintain the function and temperature of the machine as well as

record the pain intensity, knee circumference and ROM.

3.4.5 Costs for Maintaining Current Practice

The most common used painkillers in the proposed settings are PCA

(morphine), oral (Panadol, Tramodol and NSAIDs) or injected (Tramadol and


36

Pethidine) painkiller. These painkillers have not only more serious side effects,

but also more expensive. According to Department of Pharmacy, TKOH (July

2011), the cost of morphine is $3.9 per 1ml per ampule. Most of the patient use

PCA for about three to four days postoperatively. The mean of oral painkiller is

around $0.19 per tablet and the mean of injected painkiller is about $2.69 per

ampule. Most of the patients use the oral or injected painkiller during their length

of stay. All the medications are consumable (~HK$ 50/each patient/each

hospitalization); however, most of the equipments for cryotherapy can be reused.

The studies also revealed that using cryotherapy can reduce the consumption of

painkiller (Holmström & Härdin, 2005; Kullenberg, et al., 2006; Morsi, 2002).

Thus, cryotherapy is a good way to reduce pain sensation and medical cost.

3.5 Conclusion

Overall, the anticipated benefits of using cryotherapy for patients after TKR

are outweighed its potential cost and risk. In addition, the innovation can be

transferable and feasible to the target settings and audiences. Thus, it is

worthwhile to develop a new evidence-based protocol.

Chapter 4: Evidence Based Practice Protocol

37

CHAPTER 4

EVIDENCE BASED PRACTICE PROTOCOL

Based on Melnyk & Fineout-Overholt (2005), the next step of Iowa Model

is to develop an evidence-based protocol about cryotherapy.

4.1 Background

As stated before, postoperative pain and local swelling are the great barriers

that inhibit patients’ recovery and resulting in lowering the motivation of the

training adherence and affecting the postoperative rehabilitation. Consequently,

their quality of life will be influenced. Nurses play an important role in restoring

the patients’ health and alleviating their suffering. On account of this, nurses have to

develop up-to-date evidence-based practices to improve the qualities of nursing cares.

4.2 Name of the Protocol

Evidence-based guidelines of using cryotherapy in reducing pain, knee swelling

and improving range of motion for patients after total knee replacement.

4.3 Objectives of the Protocol

To reduce postoperative pain and knee swelling for patients after TKR with

the use of cryotherapy

To optimize the pain management through a safe and cost-effective practice


38

4.4 Target Population of the Protocol

The target population of the protocol are:

all the patients who have undergone TKR in the target wards

except those who have contraindication to cryotherapy

circulatory insufficiency (e.g. peripheral vascular disease)

cold allergy (e.g. cold urticaria)

cutaneous sensory abnormalities

cryoglobulinemia

Raynaud’s phenomenon

haemoglobinopathy

advanced diabetes

cognitive intact to follow the instructions

willing to apply the cryotherapy at the postoperative stages

4.5 Rating System for the Recommendations

According to the designated levels of evidence of the reviews in Appendix

6, the grades of each recommendation is assigned by “SIGN 50: A Guideline

Developer's Handbook - Annex B: Key to Evidence Statements and Grades of

Recommendations” from Scottish Intercollegiate Guidelines Network (2008) (see

Appendix 4).


39

4.6 Practice Recommendations

The recommended practice will be divided into five stages: preoperative

stage, intra-operative stage, early postoperative stage, middle postoperative stage

and late postoperative stage. A brief flow chart of the recommendations is shown

in Appendix 8.

1. Preoperative Stage:

Recommendation 1.1

Use cryocuff as a mean to provide continuous compression cryotherapy

Supporting evidences:

Cryocuff was a device with an inflated cuff that consisted of cold

and compression effects at the same time. (Holmström & Härdin,

2005; Kullenberg, et al., 2006) (1+; 1+)

Continuous compression cryotherapy by cryocuff could reduce

the use of analgesics and postoperative swelling as well as

improved ROM for patients with TKR significantly. (Holmström

& Härdin, 2005; Kullenberg, et al., 2006; Radkowski, et al., 2007)

(1+; 1+; 1++)


40

2. Intra-operative Stage:

Recommendation 2.1

Apply the cryocuff immediately on the affected knee after skin closure and

before releasing of the tourniquet


Applying the cryocuff instantly after surgery could reduce the

blood flow and resulting in decreasing the local inflammatory

response and oedema formation.

The immediately anaesthetic effect of local cooling is produced

by the slowing or elimination of pain signal transmission as well

as inhibits the stretch reflex and reduces muscle spasm.

(Holmström & Härdin, 2005; Kullenberg, et al., 2006; Morsi,

2002) (1+; 1+; 1-)

Recommendation 2.2

Place the cryocuff on a light dressing wound


The decrease the thickness of the dressing, the increase the

contact of cryocuff and the skin. As a result, the skin surface

temperature would be reduced and the cryotherapy effect of the


41

affected site could be maintained. (Gibbons, et al., 2001; Morsi,

2002; Radkowski, et al., 2007; Woolf, et al., 2008) (1+; 1-; 1++;

1+)

Recommendation 2.3

Place the cryocuff on the anterior part of knee as well as leave patella and

popliteal space free of pressure


Place the cryocuff directly on the anterior part of knee could

increase the effectiveness of cryotherapy for limiting pain and

swelling. (Holmström & Härdin, 2005; Kullenberg, et al., 2006;

Smith, et al., 2002) (1+; 1+; 1+)

Leaves patella and popliteal space free of pressure to prevent

complication, e.g. pressure sore or nerve function damage due to

ischemic. (Kullenberg, et al., 2006) (1+)


42

3. Early Postoperative Stage:

Recommendation 3.1

Keep the cryocuff continuously on affected knee at least 48 hours after

operation


Different studies suggested different suitable length of applying

continuous compression cryotherapy from one to six days

postoperatively. (Gibbons, et al., 2001; Holmström & Härdin,

2005; Kullenberg, et al., 2006; Morsi, 2002; Smith, et al., 2002;

Woolf, et al., 2008) (1+; 1+; 1+; 1-; 1+; 1+)

Continuous cryotherapy had better pain control, especially during

night time, on the second postoperative day. (Woolf, et al., 2008)

(1+)

Recommendation 3.2

Keep the temperature of cryocuff at 7°C to 15°C


The cryotherapy with temperature from 10°C to 15°C had

significant reduced in using pharmacological method for pain

control. (Holmström & Härdin, 2005) (1+)


43

The cryotherapy with temperature from 7°C to 12°C had

significant advantages on pain control and ROM. (Morsi, 2002)

(1-)

Recommendation 3.3

Re-chill the cryocuff regularly to maintain the cryotherapy


Change the ice water in cryocuff when it is melted to keep its

function. (Gibbons, et al., 2001; Holmström & Härdin, 2005;

Kullenberg, et al., 2006; Morsi, 2002; Radkowski, et al., 2007;

Smith, et al., 2002; Woolf, et al., 2008) (1+; 1+; 1+; 1-; 1++; 1+;

1+)

Change the ice every 4 hours (Kullenberg, et al., 2006) (1+)

Recommendation 3.4

Regular assessment to evaluate the effectiveness of cryotherapy in pain relief


The effectiveness of cryotherapy in reducing pain sensation and

should be assessed to optimize the pain management in order to

promote the rehabilitation and improve the quality of life.

(Kullenberg, et al., 2006; Morsi, 2002; Woolf, et al., 2008) (1+; 1-;


44

1+)

Recommendation 3.5

Regular assessment to prevent the undesired complications


Cold related complication, e.g. frostbite (thermal skin injury),

transient nerve palsy, wound dehiscence and deep vein thrombosis,

should be observed to prevent extra pain or discomfort and

decrease the quality of life. (Gibbons, et al., 2001; Kullenberg, et

al., 2006; Morsi, 2002; Radkowski, et al., 2007; Smith, et al., 2002;

Woolf, et al., 2008) (1+; 1+; 1-; 1++; 1+; 1+)

4. Middle Postoperative Stage:

Recommendation 4.1

Disconnect the cryocuff system with the cuff remained on the affected knee

during mobilization


To unplug the system and keep the cuff remained on to provide

continuous compression cryotherapy during mobilization.

(Holmström & Härdin, 2005) (1+)


45

5. Late Postoperative Stage:

Recommendation 5.1

Apply intermitted ice pack regimen on affected knee three to six times daily

and for 15 to 20 minutes in each time after removal of cryocuff in the

remaining length of stay


Cryotherapy by cryocuff has less nighttimes’ pain on the

postoperative day 2 compared with intermitted ice bag therapy.

Otherwise, there is no significance difference in pain control

between continuous cryotherapy and intermitted ice bag therapy

in the following time. Thus, intermitted ice pack regimen would

spend less labour intensive to manage and have less complication.

(Smith, et al., 2002; Woolf, et al., 2008) (1+; 1+)

4.7 Conclusion

Since the proposed protocol is developed with reference to the relevant, up

to date and high qualified research studies, it is believed that the evidence-based

recommendations in the new protocol can effectively reduce the postoperative

pain and local swelling for patients after TKR as well as ameliorate their quality

of life in order to maximize their benefits.

Chapter 5: Implementation Plan

46

CHAPTER 5

IMPLEMENTATION PLAN

After developing the new protocol, the next step is to establish the

implementation plan. A pilot study is necessary to test its feasibility and

transferability before a larger-scale implementation. To ensure the protocol to be

carried out smoothly and efficiently, a good communication plan is required in

advance (Melnyk & Fineout-Overholt, 2005). In this chapter, a communication

plan and a pilot study will be discussed to develop the implementation plan.

5.1 Communication Plan

Gaining approval and support from the stakeholders is the key essential

factors to the success of the new implementation plan. Therefore, a well-planned

communication plan is important at the beginning.

5.1.1 Identifying Stakeholders

Before developing the communication plan, the stakeholders of the protocol

that will be affected by the innovation should be identified. They are:

1. Decision makers, such as the Chief of Service (COS), Departmental

Operational Manager (DOM), Ward Manager (WM), Nursing Officers

(NOs) and Advanced Practice Nurses (APNs).

2. Project team including one APN (for support) and three registered


47

nurses (one is the coordinator)

3. Nurses in the target wards

4. Orthopaedic doctors

5. Allied health professionals, such as physiotherapists and occupational

therapists

5.1.2 Communication Plan with Stakeholders

According to the Iowa Model, the organization support from the top to the

bottom is important for implementing and sustaining the innovation (Melnyk &

Fineout-Overholt, 2005; Polit & Beck, 2008). It is because the managerial support

is a key factor in promoting the change. Thus, the communicating sequences

should be in the order of 1 to 5 presented as above.

5.1.2.1 Communication with Decision Makers

The decision makers play an important role in starting the innovation.

Therefore, gaining their approval and support is the best begun. Firstly, the

coordinator of the project team will be responsible for communicating with the

ward manager, nursing officers and advance practice nurses. The increasing

operation rate of TKR as well as the needs and advantages of introducing the new

practice are presented to them with relevant research findings, critique and

synthesis that discussed in Chapter 1 and 2 before. Besides, the implementation


48

potential such as feasibility, transferability and cost-benefits in Chapter 3 will be

showed to persuade their support. Eventually, they approved the innovation and

agreed to discuss it in the senior staff meeting.

The next step is to communicate with the Chief of Service and

Departmental Operational Manager. A PowerPoint will be prepared for the senior

staff meeting. The PowerPoint are the summary of the dissertation which focus on

the evidence-based findings from the researches, advantages of the innovation,

implementation potential and plan, the budget, time plan (see Appendix 9) as well

as the evaluation plan. Finally, they approve the evidence-based practice and

agree to implement it into the target setting.

5.1.2.2 Communication with Project Team

A project team will be established after the protocol developed. There will

be an advance nurse practice (for support) and three registered nurses (one is the

project coordinator) in the team. The major duties of them are to communicate

with and educate other stakeholders. In addition, they have to monitor the

implement and evaluate the protocol. In view of these, they should understand the

program thoroughly and be well-prepared in advance.

According to Melnyk & Fineout-Overholt (2005), a well preparation is a

key factor to start and sustain a new innovation. Therefore, two training


49

workshops are needed for the project team members before implementing new

protocol. The aims of the workshops are to:

1. discuss the purpose and importance of cryotherapy for patients after

TKR

2. present the protocol contents

3. clarify their roles and responsibilities

4. train the communication, education and troubleshooting skills

5. introduce the implementation and evaluation skills with charts, audit

tool and feedback collection.

Official release to attend the training workshop will be approved by ward

managers, so as to ensure that all members can join the workshops.

1st workshop. It lasts about two hours to introduce the importance of

implementing the new protocol with the support of evidence findings. The

cryotherapy programme and protocol will be presented. Face-to-face

communication is preferred to encourage discussion and question. For further

references, a package will be distributed to all project team members to ensure

they understand the program thoroughly before implementation. The package

includes the summary of:

evidence findings of TKR and its complications


50

advantages of cryotherapy

pilot study

target populations

role and responsibilities of the team members

2nd workshop. This workshop will provide the details of implementation

and evaluation of the protocol. It will last about two to three hours and use

PowerPoint as the main media in this workshop. Feedback, discussion and

question can be raised in-between the presentation. For reinforcement, a package

of the protocol with implementation guide, assessment tools, evaluation tools and

the use of goniometer and cryocuff will be provided to all members. The package

was composed of:

summary of the protocol

time plan of the implementation and evaluation (see Appendix 9)

flow chart of the protocol (see Appendix 8)

measurement, assessment and evaluation tools (see Appendix 10, 11

and 12)

use of goniometer and cryocuff

data collection and analysis methods


51

5.1.2.3 Communication with Nurses in the Target Wards

The compliance and acceptance by the nurses are important factors in the

success of implementation of the protocol. However, most people are reluctant to

change the usual practice and adapt a new protocol, except, it benefit themselves

and other people. Moreover, insufficient awareness and understandings are

another resistance for the implementation. Hence, advantages of implementation

new innovation, such as reduce length of stay and the workload after complication

developed, clarification of misunderstand and uncertainties of the protocol should

be explained to the staff before implementation in order to enhance their

acceptances and interests. In view of this, poster and board as well as briefing and

training can be utilised.

Poster and board. Raising awareness of nurses with evidence-based

findings can promote their change. So, the summary of background, affirming

needs and significance of the evidence-based protocol will be displayed on the

posters and boards to enhance their awareness and interest.

Briefing and training. Six to eight sessions will be required to introduce the

new protocol, measurement tools, assessment tools, evaluation tools,

documentation charting, their roles in protocol explanation to patients, data

collection for evaluation and proper operation procedure of cryocuff. Each session


52

will last for about one to two hours including explanation, question and answer

time.

5.1.2.4 Communication with Orthopaedic Doctors

The cooperation from orthopaedic doctors is also important as they are

responsible for applying the cryocuff immediately after the surgery as well as

prescribing the post operative medication and treatments for patients. The project

team will explain the details of the protocol, including its importance and

significances, advantages of innovation, their roles and implementation strategies

to the orthopaedic doctors in their weekly meeting. In the presentation, there will

be a question and answer session to explain and clarify their concerns in order to

invite their participance as well as enhance their acceptances and cooperations.

5.1.2.5 Communication with Allied Health Professionals

The allied health professionals such as physiotherapists and occupation

therapists are another leading factor to the success of the protocol implementation.

They play important roles in rehabilitation of patient after surgery. Therefore, the

cooperation of them is another hint to increase the compliance of the protocol of

patients. The project team will explain the details of the protocol, its importance

and significances, advantages of innovation, their roles and implementation

strategies to the allied health professionals in their weekly meeting as well. In the


53

meeting, there will be a question and answer session to explain and clarify their

concerns in order to invite their participance as well as enhance their acceptances

and cooperations.

5.2 Pilot Testing

After communication with the stakeholders, based on Polit & Beck (2008),

the next step is to carry out a pilot study. Pilot test is a trial run design and small

scale preliminary study conducted to test the feasibility and transferability of the

protocol. A pilot study is to test the logistics and gather data before a larger-scale

implementation to improve the latter’s quality and efficiency.

5.2.1 Objectives

The objectives of the pilot study are to:

1. test the feasibility and transferability of the protocol

2. assess nurses competency in using the new protocol as well as

measurement, assessment and evaluation tools

3. assess the patients acceptance towards the new developed protocol

4. identify unpredictable problems and barriers of the study and improve

the larger-scale implementation.

5.2.2 Target Setting and Target Population

The target setting and target population of the pilot study are the same as


54

the proposed setting and audiences which described in Chapter 3.1.

5.2.3 Sampling Plan

There are two orthopaedic wards in the target hospital: one is male ward

and another is female ward. Also, three to four suitable cases can recruit weekly in

a ward. As a result, about 30 candidates can be enlisted in four weeks.

5.2.4 Implementation

At the beginning, nurses will explain the content of the protocol thoroughly

to the target patients during admission. After that, the patients will start the

cryotherapy immediately since operation performed according to the new

developed guideline. Postoperative pain sensation will be documented in pain

management record chart (see Appendix 10) at least twice per day. The knee

circumference and range of motion will recorded in knee circumference record

chart and range of motion record chart respectively (see Appendix 11 and 12)

everyday. In between, verbal or written feedbacks and comments from staff and

patients will be collected to monitor the feasibility and transferability of the new

developed guideline. Regular assessment is necessary to measure the staff

competency in using the protocol as well. Finally, a special chop will be stamped

on the last page of clinical management sheet with the content of:


55

This patient has *continued / discontinued to follow the cryotherapy

protocol during hospitalization.

*delete as appropriate

to measure the patients’ acceptance towards the guideline before discharge.

5.2.5 Outcomes to be Measured

The outcomes of the pilot study that should be measured are as followed:

feasibility and transferability of the protocol

nursing competency in using the protocol as well as measurement,

assessment and evaluation tools

patients acceptance towards the new protocol

5.2.6 Data Collection and Analysis

The pilot test will be analysed in terms of outcomes that showed as above.

For the feasibility and transferability of the protocol, feedback from the

stakeholders including nurses, patients, doctors and allied health professionals as

well as the unpredictable problems and barriers which encountered during the test

will be collected for evaluation. For monitoring the nursing competency in using

the protocol and documentation tools, the records will be reviewed to check if the

documents are charted correctly as well as verbal feedback and written evaluation

form from staff will be gathered. Lastly, the continuity of using cryotherapy will


56

be assessed before discharge to check the patients’ acceptance towards the new

developed protocol.

5.2.7 Conclusion

The pilot test is a preliminary study which is essential before

implementation of the new developed protocol. If it shows that the protocol is

feasible and transferable, the confidence of full implementation will be greatly

enhanced. On the other hand, if there are barriers or problems in the pilot study

implementation, amendment and modification may be needed to considerate.

Except this, the support from the decision makers is important for carrying out the

protocol. Hence, a written report should be prepared for the managerial level in

senior staff meeting to report the progress and results of implementation.

Chapter 6: Evaluation Plan

57

CHAPTER 6

EVALUATION PLAN

When the pilot study results support the full implementation of the

cryotherapy protocol, it is time to develop an evaluation plan systematically. In

this chapter, a comprehensive evaluation plan will be presented.

6.1 Outcome to be Achieved

The first step of developing an evaluation plan is to determine which

outcomes should be achieved. The outcomes could be divided into two parts: (1)

Primary outcomes and (2) Secondary outcomes. In this protocol, the primary

outcome is the patients’ outcomes including the postoperative pain sensation, knee

circumference and ROM. The secondary outcomes are the patients’ acceptance,

nurses’ competency in using the protocol and documentation tools as well as

system outcome.

6.1.1 Primary Outcomes

As presented, the main objectives of the protocol are to reduce the

postoperative pain, knee swelling and improve ROM of knee for patients after

TKR. Therefore, the intensity of pain, knee circumferences and its ROM are the

primary outcomes to be measured for determining the effectiveness of the

protocol.


58

The intensity of pain will be measured by Pain Management Record Chart

which is designed by the target hospital (see Appendix 10). About four studies

described the use of Visual Analogue Scale (VAS) as pain assessment tools in their

researches (Holmström & Härdin, 2005; Kullenberg, et al., 2006; Morsi, 2002;

Woolf, et al., 2008). The Numerical Rating Scale (NRS) and Faces Pain Scale

Revised (FPS-R) that used in the target settings are similar to the the VAS used in

the studies. Both NRS and VAS use rating scale to represent the pain. They use a

horizontal line with 0 to 10 marked from left to right equally and respectively. 0

indicate as no pain and 10 indicate as the worst possible pain. The main

differences are the patients rate their pain on a scale by number from 0 to 10

verbally on NRS, while the patients mark a point on the line to measure their pain

visually on VAS. For FPS-R, it will be used for patients who are unable to use

NRS. It also similar to VAS to rate their pain from no pain on the left-most face to

the worst pain on the right-most face visually and then score the chosen face from

0 to 10. Therefore, it is feasible to use the Pain Management Record Chart as a

pain measurement tool in the proposed setting.

For knee swellling, knee grith will be measured in both intervention group

and control group to evaluate the outcome. The circumfernce in mm at mid-patella

with the knee in maximum extension will be recorded on the Knee


59

Circumferences Record Chart (see Appendix 11) at the same time in everyday to

minimize the bias. 50% of the studies that mentioned about knee swelling used

this methods to evaluate their outcomes (Holmström & Härdin, 2005) as well.

Thus, it is a workable measurement to evaluate the outcome of knee swelling in

the target wards.

Only one study mentioned the measurement method of ROM in details

(Holmström & Härdin, 2005), whereas others studies just presented with

measuring time or measurement tools briefly (Kullenberg, et al., 2006; Morsi,

2002; Radkowski et al., 2007; Smith, et al., 2002). Holmström & Härdin (2005)

suggested to measure at a standard reference points on sitting position with a

goniometer and recorded as maximum active and passive extension and flexion.

The results can record in the self-developed record chart (see Appendix 12). This

method is transferable to the target settings for measuring the ROM of knee.

6.1.2 Secondary Outcomes

Patients’ acceptance, nurses’ competency in using the protocol and

documentation tools as well as system outcomes are the secondary outcomes to be

achieved.

Patients’ acceptance towards the protocol is important for implementation.

Although cryotherapy is a safe practice in reducing pain and swelling, there is still


60

risk of complication developed. Holmström & Härdin (2005) reported one patient

requested to take off the cryocuff during implementing the cryotherapy and one

patient had cold sensation but able to continue the treatment. Kullenberg, et al.

(2006) showed one patient developed deep vein thrombosis and one patient had

superficial infection of unknown reason in the cryotherapy group. In view of this,

nurses should explain the content of the protocol thoroughly to the target patients

before. Also, a special chop will be stamped on the last page of clinical

management sheet with the content of:

This patient has *continued / discontinued to follow the cryotherapy

protocol during hospitalization.

*delete as appropriate

to monitor their acceptances towards the new developed guideline.

Moreover, good documentation will enhance the data collection and

analysis in order to facilitate the evaluation process. Therefore, the documentation

records will be reviewed regularly. Verbal feedback and written evaluation form

will be gathered to synthesize the comment.

Material and non-material costs used in the implementation period will be

recorded for evaluation. The material costs include the paperwork and

documentary equipment, e.g. document charts and chops; cryotherapy items, e.g.


61

cryocuff with temperature control, ice maker, tap water, plastic bags, electricity,

etc; medication costs; measuring items, e.g. goniometer and measuring tape; as

well as the non-material costs involve the staff cost per hour that spent on training;

cost for complication development and prolonged length of stay.

6.2 Nature and Number of Clients

The second step is to determine the nature and number of clients to be

involved in the evaluation plan.

6.2.1 The Nature of the Clients to be Involved

The nature of the clients can be referred to the target audiences mentioned

in Chapter 3.1.2, that is all patients who have undergone TKR in two orthopaedic

wards in a public hospital from Hospital Authority, except: (1) those who have

contraindication to cold therapy, (2) cognitive not intact to follow instructions and

(3) patient who are reluctant to apply the cryotherapy at the postoperative stages.

6.2.2 The Number of the Clients to be Involved

Before determining the number of the clients to be involved, the main

outcomes and the evaluation objectives of the guideline should be identified. The

main outcome is to reduce the postoperative pain, knee swelling and improve the

ROM for patients after TKR. The evaluation purpose is to determine the effective

of the guideline in reducing the pain and swelling by comparing with the


62

intervention group and control group. Hence, two-sample t-test should be used as

the method of analysis.

The sample size will be obtained by the web software which developed by

Lenth (2006-9). Four main components should be calculated or adjusted before

estimating the sample size: (1) standard deviation, (2) power, (3) true difference of

means and (4) ρ-value. The data for sample size calculation can be adapted from

the seven relevant studies (Gibbons, et al., 2001; Holmström & Härdin, 2005;

Kullenberg, et al., 2006; Morsi, 2002; Radkowski et al., 2007; Smith, et al., 2002;

Woolf, et al., 2008).

According to those studies, for the postoperative pain, the standard

deviation is 1.32 in the intervention group whereas 1.6 in the control group. The

true average difference of means that computed is 0.82. The power will be set to

0.8 as that is the customary standard for power. Based on Pilot and Beck (2008),

there is 20% risk of committing Type II error if the power to be fixed as 0.8. The

ρ-value will be set as 0.05 to have a significance result. Hence, the sample size of

51 candidates in each group is figured out. With the application of attrition rate

about 10%, 64 patients are needed in each group.

There are only two studies had discussed about the result of knee swelling

(Holmström & Härdin, 2005; Smith, et al., 2002). So, the data will be generated


63

from them. The standard deviation is 16 mm in the intervention group and 20 mm

in the control group. The true average difference is 8.5 mm. The power will be set

to 0.8 and ρ-value is 0.05. As a result, 72 cases are estimated for each group.

Counting with about 10% attrition rate, 80 patients are required in each group.

For calculating the sample size in ROM, four studies are involved

(Holmström & Härdin, 2005; Kullenberg, et al., 2006; Morsi, 2002; Smith, et al.,

2002). The standard deviation will be set to 13.95° in intervention group and

12.91° in control group. The true average difference is 8.42°. The power will be

equal to 0.8 and ρ-value is 0.05. By Lenth (2006-9), a sample size of 41 per group

is estimated. Due to about 10% attrition rate, 45 cases are necessary in each

group.

To conclude, about 80 patients are required for both intervention group and

control group in the evaluation plan. Since there are about three to four cases

admitted for scheduled TKR each week in each ward, at least 20 weeks are needed

to recruit enough candidates and 22 weeks for data collection.

6.3 Time and Frequency of Taking Measurements

The next step is to determine when and how often to take the measurement

of the primary and secondary outcomes.


64

6.3.1 Primary Outcomes

The aims of the new protocol are to reduce the postoperative pain, knee

swelling and increase the ROM. Thus, the measurements should be taken after

operation. The intensity of pain will be measured at least twice daily which set by

the pain assessment protocol in the target hospital. The frequency of assessment

can be increased if patients’ pain intensity is aggravated. Besides, the pain

assessment should be done after intervention implemented in order to evaluate the

effectiveness of the interventions. For the knee swelling, bilateral knee girths will

be recorded at the same time every day until discharge in order to minimize the

bias. Because of the ward practice, it is be usually measured around seven o’clock

every morning by nurses. Nurses are required to check the ROM of knee at the

same time every day as well in virtue of keeping consistence. To be convenience,

it will be measured with knee swelling measurement.

6.3.2 Secondary Outcomes

The patient’s acceptance towards the new guideline can be measured before

discharge. The cryotherapy team members can calculate the number of people

who accept using cryotherapy after the surgery for evaluating the acceptance rate

of the protocol. For nurses’ competency in using the guideline and documentation

tools, verbal feedback and comments will be collected at any time after


65

implementation as well as written evaluation form will be received at 12 weeks

and 22 weeks after implementation of the protocol. The expense of the protocol

would be recorded along the implementation period to monitor if everything is in

budget.

6.4 Data Analysing Methods

Based on Polit and Beck (2008), the next step is to define the data analysing

methods of the evaluation results. In quantitative study, the data analysis is to test

the hypotheses by using the data collected. As presented, the data of primary

outcomes including postoperative pain, knee swelling and range of motion will be

collected in numeric form and produce quantitative data. After that, the mean,

which is the sum of all scores divided by their number, and the standard deviation,

which is the average amount of deviation from the mean, can be calculated for

describing the data. Thus, by using t-test, the differences between the means of

two groups can be estimated.

For secondary outcomes, the data of patients’ acceptances can be gathered

by the number of patients who accept using cryotherapy after surgery for

evaluating the acceptance rate, which is also in numeric form. Besides, the data

for nurses’ competency in using the guideline and documentation tools will be

collected by a written evaluation which is a Likert Scale with 5-point responses:


66

(1) strongly agree, (2) agree, (3) neutral, (4) disagree and (5) strongly disagree.

Each response will have a numerical value for data analysis. Therefore, they can

be interpreted by using t-test as well. Finally, to analyse the cost-effectiveness,

comparison between the material and non-material costs used in implementing the

new protocol as well as the cost of continuing current practice such as the

medication expense, treatment cost after complication developed and cost of

prolonged length of stay will be performed for evaluation. The net balance can

reveal the advantages of implementing the new protocol.

6.5 Effectiveness of the Protocol

The last step is to evaluate the effectiveness of the protocol. Since the main

objectives of the guideline are to reduce the postoperative pain, knee swelling and

improve ROM for patients after TKR, the primary outcomes have the first priority

to determine the effectiveness of the protocol. However, the patients’ acceptances

towards the protocol and the nurses’ competency in using the protocol will affect

the results of evaluation. So, the secondary outcomes are also important. In view

of this, the new protocol will be considered as effective if the results can achieve

the following bases:

1. For postoperative pain, as the average mean difference among the literatures

is about 0.82 (Gibbons, et al., 2001; Holmström & Härdin, 2005; Kullenberg,


67

et al., 2006; Morsi, 2002; Radkowski et al., 2007; Smith, et al., 2002; Woolf,

et al., 2008), it can be considered as effective if the mean differences of pain

score reduce at least 1 which compared with the control group.

2. For knee swelling, only two studies are presented about these results

(Holmström & Härdin, 2005; Smith, et al., 2002). The true average

difference of the knee girth is about 8.5mm. Therefore, the new guideline

will be effective in reducing knee swelling if the knee circumferences can

reduce at least 10 mm which compared with that of control group.

3. For the ROM of knee, the true average difference among the four studies is

8.42° (Holmström & Härdin, 2005; Kullenberg, et al., 2006; Morsi, 2002;

Smith, et al., 2002). Hence, the protocol will be reflected as effective if ROM

in intervention group larger 10° than that in control group.

4. For patients’ acceptance, by observation, nearly all patients accept to use

cryocuff in other knee surgery. Therefore, for conservative estimation, it will

be effective if there are at least 80% of patients who follow the cryotherapy

guideline during hospitalization.

5. As shown, nurses play an important role in implementing the new guideline;

therefore, their competencies are also need to be considered for an effective

protocol. Accordingly, if positive feeling and feedback towards the new


68

guideline are collected as well as good documentation and regular review

performed by nurses, the protocol can be decided as effective.

6.6 Conclusion

To sum up, the effectiveness of the guideline is determined by the primary

outcomes and secondary outcomes. Thus, the guideline is effective and can be

applied to the proposed setting in a long period of time if positive outcomes are

leaded. On the other hand, if negative outcomes are generated, the guideline may

have to be amended. However, the guideline is developed from updated and high

quality studies. Therefore, it believed that it will be effective.

Chapter 7: Summary

69

CHATPER 7

SUMMARY

According to the reviewed study, cryotherapy is suggested as a safe,

economical and efficient method in managing the postoperative pain, knee

swelling and ROM for patients after TKR. However, cryotherapy is not

performed as a common practice in most places such as the proposed settings. In

this regard, a systematic, critical and evidence based guideline of the related issue

has been conducted. The relevant evidences which transferred from the reviewed

study are used to establish the protocol for patients in the proposed settings with

well-designed implementation and evaluation plan suggested. It is hoped that the

new developed guidelines is beneficial to patients after TKR in an orthopaedics

settings in order to preserve patients’ quality of life and relieve healthcares’

burdens.

Appendices

70

APPENDICES

Appendix 1: Table of Electronic Databases

Keyword(s) MEDLINE

(Ovid) (1948 – 2011)

BNI (Ovid)

(1994 – 2011)

BNIA (Ovid)

(1985 – 2011)

CINAHL Plus

(EBSCOhost)

PubMed (NCBI)

Cochrane Library (WOL)

(1) Total Knee Arthroplasty 20520 28 33 (2) Total Knee Replacement 10318 245 252 (3) Cryotherapy 6452 26 28 (4) Cold therapy 3160 7 10 (5) Pain 395920 6117 8035 (6) (1) or (2) 21012 269 280 (7) (3) or (4) 6499 32 37 (8) (5) and (6) and (7) 20 0 0 (9) (6) and (7) 2 2 (10) (1) and (3) and (5) 6

19 5

(11) (1) and (4) and (5) 4 5 (12) (2) and (3) and (5) 2

12 4

(13) (2) and (4) and (5) 4 6 (14) Limited (8) to English and publication year

from 2001 to current 10

(15) Limited (9) to publication year from 2001 to current

2 2

Appendices

71

Keyword(s) MEDLINE

(Ovid) (1948 – 2011)

BNI (Ovid)

(1994 – 2011)

BNIA (Ovid)

(1985 – 2011)

CINAHL Plus

(EBSCOhost)

PubMed (NCBI)

Cochrane Library (WOL)

(16) Limited (10) to English and publication year from 2001 to current

4


2


2


2

(20) Limited (10) and (11) to English and published in the past ten years

10

(21) Limited (12) and (13) to English and published in the past ten years

8

Related to the topic (by a quick look on title only) 10 2 2 3 10 1 Related to the topic and belong to controlled trials (by looking at the abstract and the text)

5 1 1 1 5 0

From reference lists 1 Total number of studies 7

Appendices

72

Appendix 2: Tables of Evidences

Bibliographic Citation

Study Type

& Ev Lv.

Number of Patients

Patient Characteristics Intervention Comparison Length of

follow upOutcome Measures Effect Size

1. Gibbons, et al. (2001)

RCT 1+

Total: 60 Cryo/Cuff: 30 patients Robert Jones: 30 patients

Cryo/Cuff: - Age: 70 yrs old - Sex ratio M/F:

11/19 - Osteoarthritis: 25 - Rheumatoid

arthritis: 5 - Knee score: 37 - Function Score: 47- Mean blood loss:

720 ml - Patients

transfused: 6 Robert Jones: - Age: 71 yrs old - Sex ratio M/F:

14/16 - Osteoarthritis: 27 - Rheumatoid

arthritis: 3 - Knee score: 40 - Function Score: 39- Mean blood loss:

1200 ml - Patients

transfused: 7

Cold compression dressing: - Placed over a single

layer of crepe and Velband immediately after OT

- Layer removed by PT once back to ward

- Cryo/Cuff with inflatable cuff place on the knee and attached at the back with Velcreo straps

- Cuff filled with ice water via a tube attached to ice bucket

- Cuff with compression and cold therapy, last to 60 mins

- No CPM - Physiotherapy same

as control gp - Minimum 6 hrs

during the day until discharge

Modified Robert Jones bandage: - Firm

compression in 3 layers Velband and crepe, which remained in place for 48 hrs

- No CPM - Physiotherapy

same as intervention gp

Pre-op to 10 days after OT

Before OT: - Pain scores

by visual analogue scale (0-100)

After OT: - Amount of

morphine used via PCA for the first 48hrs

- Amount of oral analgesic used up to 10 days

- Pain Scores recorded on alt. days after physiother-apy at the end of afternoon

Range of motion: - Cryo-cuff gp: 5° – 82° - Robert Jones gp: 3° – 78° - P > 0.05 Pain scores: Cryo-cuff gp: - Pre-op: 60+ - Day 1: 60+ - Day 3: 30+ - Day 5: 40+ - Day 7: 30+ - Day 9: 20+ Robert Jones gp: - Pre-op: 70+ - Day 1: 60+ - Day 3: 40+ - Day 5: 40+ - Day 7: 40+ - Day 9: 30+ - P > 0.05 Analgesia: Cryo-cuff gp: - morphine used:

0.65 mg/kg/48hrs - Oral analgesia: 44 doses Robert Jones gp: - morphine used:

0.6 mg/kg/48hrs - Oral analgesia: 40 doses - P > 0.05 Complication: - No recorded complication

General Comment: There is no statically significant different between 2 groups in range of motion, pain scores and need for analgesic.

Appendices

73


Study Type& Ev Lv.

Number of Patients

Patient Characteristics Intervention Comparison

Length of

follow up

Outcome Measures Effect Size

2. Holmström & Härdin (2005)

RCT1+

Total: 60 Cryo: 23 EDA: 21 Control: 17

Cryo: - Age: 68 yrs

old - Sex ratio

M/F: 9/14 - Weight: 75 kg- VAS at rest: 1- VAS on

motion: 5 - Function

(ISK): 12 EDA: - Age: 75 yrs

old - Sex ratio

M/F: 6/15 - Weight: 77 kg- VAS at rest: 1- VAS on


(ISK): 15 Control: - Age: 72 yrs

old - Sex ratio

M/F: 6/11 - Weight: 77 kg- VAS at rest:

1.5 - VAS on


(ISK): 13

- All patients received traditional analgesics: paracetamol 500mg, dextropropoxyfene 50 and 100mg, supplementary morphine, oral 5mg and IV 5mg/ml when required

- Rehabilitation started on Day 1

Pre-op to 6 weeks after TKR

Pain: VAS (0-10) - At rest and on motion - Every 24hrs - From end of surgery to

Day 6-7 - Recorded by

physiotherapist, nurse or patient if discharged before observation time

- Consumption of injectable and oral morphine from surgery to Days 6-7 was summarized every 24 hrs

Range of motion: standard reference points on sitting position with a goniometer and recorded as max active and passive extension and flexion - Measured on pre-op,

Day 7 and Week 6 with same tools

Knee girth: circumference in mm at mid-patella with the knee in max extension - Measured on pre-op,

Day 7 and Week 6 with same tools

Pain at rest: VAS Pre D1 D2 D3 D4 D5 D6 D7 W6

1 1 3+ 2+ 1+ 1+ 1+ 1 0+ 0+ 2 1 2+ 2+ 1 1+ 1+ 1 1+ 0+ 3 1+ 3 2+ 1 2+ 2 2 2 1

Pain on motion: VAS Pre D1 D2 D3 D4 D5 D6 D7 W6

1 5 5+ 5 4 3+ 3+ 2+ 2 1+ 2 5 4 4+ 4 3+ 2+ 2+ 2+ 1+ 3 4+ 5+ 4+ 3 4 4+ 3 3+ 1+

1 = Cryo/Cuff; 2 = EDA; 3 = Control Morphine requested:

Day 1 - Cryo: 13.4mg (100%) (P=0.028) - EDA: 7.5mg (65%) (P < 0.001) - Control: 20.8mg (100%) - Different between Cryo and EDA is not significance Day 2 - Cryo: 3.9mg - EDA: 3.2mg - Control: 6.3mg - Different not significance

Total used in first 3 days: - Cryo: 18.7mg - EDA: 14.2mg - Control: 28.4mg - Different between EDA and Control was significance (P=0.005) - EDA: ↑ slightly after 48hrs - Cryo: constantly ↓ pain curve even after removal of the cryocuff and no

morphine is needed after Day 4 - Other groups continuously request until Day 7 Swelling: - No significant differences in swelling. (mild ↓ swelling by cryocuff

compared with EDA and control gp) Range of motion: - No significant difference in passive or active ROM - At 6 weeks, passive and active ROM was similar to pre-op ROM Complication: - Cryo: required to removal of the cryocuff before 48 hrs: 1 patient .felt cold but retained the cryotherapy: 1 patient - EDA: ↓ sensibility in both leg: 3 patients totally paralyzed in both leg: 1 patient anaesthetized in the other leg: 1 patient require to remove before 48 hrs: 1 patient

Cryo/Cuff: - Applied immediately after

skin closure and before release of the tourniquet.

- Cooling system with an insulated cuff strapped to the front of the knee

- Ice water temperature: 10°C – 15°C

- An automatic device with continuous chilling and pulsing compression of 30mmHg in intervals 30sec

- Treatment continuous for 48hr

- Ice water changed every 6 hrs or more often if melted

- At mobilization, system was unplugged and cuff remained on

EDA: - 2.5 to 5 mg/ml of

bupivacaine was administered into epidural space

- continuous administration for 48 hrs

General Comment:

Both Cryo/Cuff and EDA was significantly reduced in morphine used compared with the control group. No significant difference between groups was noted in subjective pain, swelling, ROM and function. Cryo/Cuff seems to be a risk-free, well-tolerated, little competence-demanding alternative to EDA in the postoperative pain management.

Appendices

74


Study Type & Ev Lv.

Number of Patients


follow upOutcome Measures Effect Size

3. Kullenberg, et al. (2006)

RCT1+

Total: 86 Cold compression: 45 EDA (Standard): 41

Cold compression: - Age: 68.1

yrs old - Sex ratio

M/F: 1.35/1 EDA: - Age: 68.9

yrs old - Sex ratio

M/F: 1.43/1

Cold compression: - The cryocuff

was applied after tourniquet deflated

- The cryocuff, covered the anterior part of the knee, leaves patella and popliteal space free of pressure

- For 3 days after TKR

- Rechilling every 60 mins by nursing staff for 3 days

- Ice was changed every 4 hrs

EDA (Standard): - Epidural

analgesia with ropivacain till D3

- Then, IV NSAID drugs and opioids

Pre-op to 3 weeks after TKR

Pain: Visual analogue scale - Recorded by

nurse and PT during motion

- Total consumption of analgesics in relation to patient body weight

- Analyzed by Wilcoxon signed rank test

Range of motion: - Flexion and

extension recorded by PT at D1, at discharge and 3 weeks postoperatively

- Analyzed by paired t test

1 2 Pain: (VAS) D1 2.1±1.0 2.2±0.8 D3 0.8±0.9 1.2±0.7 During exercise

3.4±1.5 2.3±1.7

Pain (mg morphine/kg/24hr)

0.37±0.11 0.43±0.05

ROM: D1 50.4±8 51.4±11.1 At discharge

75.1±10.5 62.9±12.8 (P=0.0019)

3 weeks post-op

98.9±9.4 87.6±7.8 (P=0.0045)

Completed rehab

4.3±1.1 5.6±1.2 (P=0.002)

1 = Cold compression group 2 = EDA (Standard) group Complication: Cryo: - DVT: 1 patient - Superficial soft tissue infection of

unclear origin: 1 patient - Request removal of cold compression: 1

patient EDA - DVT: 1 patient

General Comment: Combined cold compression therapy controls pain (use less analgesics), improves ROM, and may speed up the time for mobilization.

Appendices

75


Study Type & Ev Lv.

Number of Patients


Length of

follow up


4. Morsi (2002) PCT1–

Total: 60 primary TKRs carried out on 30 patients (all staged bilateral TKRs) Continuous-flow cooling devices (Group 1): 30 TKRs Control (Group 2): 30 TKRs

All staged bilateral TKRs

- After skin closure and before tourniquet deflation, knees were covered with a light sterile gauze dressing and 1 layer of sterile webril. The cooling device was applied and wrapped with a final layer of compressive crepe bandage.

- Cooling flow was applied continuous for 6 days post-operatively except for short periods for ambulatory and knee mobilization exercises.

- Skin temperature kept at 7°C±2°C for the first 2 hrs post-operatively, then maintained at 12°C±3°C

- After skin closure and before tourniquet deflation, knees were covered with a light sterile gauze dressing and 1 layer of sterile webril. And wrapped with a final layer of compressive crepe bandage.

6 weeks after OT

Skin temperature: Monatherm thermistors Pain: Visual analog pain score (1-10) - At 1 hr, 2

hrs and then every 8 hours thereafter for 6 days

Analgesic consumption recorded everyday for 6 days Range of motion: evaluated every week postoperatively for 6 weeks

1 2 Pain:

VAS 4.2 (SD, 0.74)

6.3 (SD, 1.3)

VAS always: 1 < 2 (P<0.001) Pain- killer used:

1.9 pills (950 mg)

(SD, 0.73)

2.8 pills (1400 mg) (SD, 0.63)

Always, 1 < 2, from 150% more on D1 to 27% more on D6 (P<0.01)

Range of motion:

Week 168° (48°-87°)

(SD,14.8°) 54° (25°-63°) (SD,11.04°)

P<0.01

Week 2

Flexion: 80% achieved 90°Extension: 50% (< 5°)

Flexion:64% achieved 90° Extension: 45% (< 5°)

Week 6 No significant difference in flexion-extension

1 = Continuous-flow cooling devices 2 = Compressive crepe bandage Complication: No cold related complication (e.g. frostbite, transient nerve palsy) were observed in the cold flow group. There were no different in wound healing between the 2 groups

General Comment:

Continuous-flow cold therapy is advantageous after TKR. It provides greater knee extension and flexion at week 1 to 2, lower VAS and less analgesic consumption, with no adverse effect on wound healing.

PCT = Prospective controlled trial

Appendices

76


Study Type & Ev Lv.

Number of

Patients Patient Characteristics Intervention Comparison

Length of follow

up


5. Radkowski, et al. (2007)

RCT1++

Total: 64 patients 45°F group: 28 patients 75°F group: 36 patients

45°F (N=28)

p Value

Mean age (SD)

63.7 (±10.4) 0.269

BMI (SD) 32.6 (±5.5) 0.173

Female 46% 0.124Race 0.107African American 3.6%

Caucasian 89.3% Right side 36% 0.939IKDC score 33.5 0.884Range (Lin, et al.) of motion

101° 0.713

75°F

(N=36) p

ValueMean age (SD)

66.9 (±10.4) 0.269

BMI (SD) 30.7 (±5.1) 0.173

Female 64% 0.124Race 0.107African American 16.7%

Caucasian 80.6% Right side 44% 0.939IKDC score 33.8 0.884Range (Lin, et al.) of motion

103° 0.713

IKDC = International Knee Documentation Committee

All is the same except the temperature of cuff from cryotherapy device is 45°F

All is the same except the temperature of cuff from cryotherapy device is 75°F

From OT day to Day 30

Skin temperature: temperature probes placed on the skin surface (Omega Temperature Logger, Omega Engineering Inc., Stamford, CT) All patients were evaluated in the postoperative period by the same research nurse. Pain: Verbal analog scale (0-10), narcotic consumption Self-reported knee function: IKDC Passive knee ROM: using a hand goniometer by PT

Pain: VAS 45°F 75°F

D1 6.0 5.5 D3 7.1 6.3 D30 6.2 6.5

P = 0.4 No differences in the average pain score between two groups Opioid consumption

45°F 75°F p value D1 7.1% 5.6% 0.961 D3 46.4% 25% 0.111

No differences observed in the postoperative Opioid consumption between the two groups No differences in early postoperative ROM between two groups No differences in patients’ self-reported postoperative functional scores between two groups Complication: No incidences of wound dehiscence or nerve palsies.

General Comment:

With the colder 45°F cryotherapy temperature following TKR, no improvement was observed in the short-term postoperative narcotic consumption and pain scores, ROM and self-reported knee function. No adverse effects were reported with the cryotherapy treatment.

Appendices

77


Study Type& Ev Lv.

Number of Patients


Length of

follow up


6. Smith, et al. (2002)

RCT 1+

Total: 84 patients Compression Bandage Group (Woolf, et al.): 40 Cold Therapy Group (Brander & Stulberg): 44

CB: - Mean age

(SD): 72yr (7.1)

- Weight kg (SD): 78.5kg (19)

- M/F: 21/19 CT: - Mean age

(SD): 72.1yr (7.8)

- Weight kg (SD): 77.4kg (12)

- M/F: 21/23

CT: - The pressure

bandage was removed 6 hours postoperatively and cold therapy via the cryo-pad machine was initiated.

- Cryo-pad was placed directly over but not around the incision site.

- Cryo-therapy machine was set to infuse the pad with cold water between 2°C and 5°C for 15 mins and then deflated for 15 mins.

- The pad machine was removed after 24 hours of use and follow CB routine (applying ice packs three times per day for 15 mins for the next 24 – 48 hours.

CB: - The

bandage was left intact for 24 hours before its removal.

- Ice in plastic bags wrapped in a linen towel was then applied to the wound site three times per day for 15 mins for the next 24 to 48 hours.

Pain: Visual analog scale (1-10) Pain: measure analgesia use, especially opiate used. Knee flexion and swelling: by PT at approximately the same time each day.

Variable (measure) Compression Bandage Significance Mean (SD) Range P =

Swelling pre-op (mm) 410 (38) 380-540 0.294 Swelling 24 hr (mm) 439 (36) 385-522 0.837 Swelling 48 hr (mm) 445 (38) 381-505 0.512 Flexion pre-op (∞) 75.8 (15.4) 40-100 0.443 Flexion 24 hr (∞) 83.6 (12.9) 60-115 0.384 Flexion 48 hr (∞) 86.6 (12.3) 50-112 0.950 Pain D1 (1-10) 4.2 (2.0) 1-10 0.320 Pain D2 (1-10) 4.8 (1.9) 1-8 0.720 Pain D3 (1-10) 3.5 (1.9) 1-8 0.665 Opiates (mg/kg/48hrs) 0.32 (0.29) 0-0.99 0.245

Variable (measure) Cold Therapy Significance

Mean (SD) Range P = Swelling pre-op (mm) 412 (34) 365-490 0.294 Swelling 24 hr (mm) 438 (33) 373-490 0.837 Swelling 48 hr (mm) 439 (26) 393-485 0.512 Flexion pre-op (∞) 71.7 (15.8) 45-115 0.443 Flexion 24 hr (∞) 81.3 (11.8) 60-115 0.384 Flexion 48 hr (∞) 84.9 (13.4) 60-120 0.950 Pain D1 (1-10) 4.3 (1.8) 1-9 0.320 Pain D2 (1-10) 4.3 (2.0) 1-9 0.720 Pain D3 (1-10) 4.2 (1.8) 1-8 0.665 Opiates (mg/kg/48hrs) 0.422 (0.31) 0-1.01 0.245

Complication: no complication reported in this study Cost effectiveness and potential risk: CB: - Intact for 24 – 48 hrs. Cost: US$3 – 5 - Nursing activities: observing for ooze and regular circulation checks - 1 or 2 nursing hours be absorbed over 24 hours CT: - Potential risk: incidents of discomfort, blisters and occasionally

compartment syndrome - Cost: cyro machine: US$250

ice maker: US$1000 single use pads: US$25 each

- Nursing activities: equipment setup, maintenance of ice supply to the machine and removal and cleaning of the machine

- 1 and 2 hours work in addition to routine observations and care.General Comment:

No difference between the two management techniques for pain scores and swelling in the first 48 hours of the postoperative period. A cost benefit analysis showed the compression bandaging is cheaper and less labor intensive to manage than the cold therapy.

Appendices

78


Study Type & Ev Lv.

Number of Patients


follow up Outcome Measures Effect Size

7. Woolf, et al. (2008)

RCT1+

Total: 60 patients, 7 of them excluded → 53 patients Continuous temperature-controlled cryotherapy system (CTC): 24 patients Ice pack regimen (Ice therapy): 29 patients

- Mean patient age: 42.5 years (range: 14 – 73 years old)

- Women were significantly older (47.2 vs. 37.7 yrs old, P<0.05)

- No significant differences (P=0.77) in general personality trait.

- ↑% in CTC underwent more severe surgical procedure (38.5% vs. 26.7% in ice therapy) (P=0.35)

- Knee stability: 71.5% (Ice therapy) vs. 100% (CTC) reported instability (P=0.03)

CTC: - The sterile cooling

bladder was applied over the Webril, and a layer of sterile biascut stockinette was wrapped around the knee.

- Patients were instructed to fill cooler with ice prior to sleep and allow the device to operate through the night for the first 4 days.

- Patients then were instructed to use the device at their own discretion whenever experiencing pain during the remaining 10 days.

Ice therapy: - Apply an

ice pack plus compressive dressing to the affected knee for 20 mins every 2 hours while awake for the first 4 days

- Use the ice pack at their own discretion whenever pain was experienced at night or during the remaining 10 days of the protocol

Post-op Day 2 to Day 14

Pain: 5-point verbal analog rating scale

Pain Intensity Score (95% CI) Ice Therapy CTC

D2 2.95 (2.41-3.48) 2.64 (2.25-3.02) D5 2.15 (1.63-2.27) 2.23 (1.76-2.69) D8 1.90 (1.35-2.44) 2.20 (1.63-2.78) D11 1.46 (1.01-1.91) 1.66 (1.06-2.25) D14 1.60 (0.91-2.28) 1.15 (0.72-1.57)

Pain intensity: mild (did not awaken) - 35.7% in CTC vs. 5.9% in ice

therapy (P=0.04) - % of CTC with night pain which

disrupted their sleep < Ice therapy (significant on Day 2 only)

- No patient in either groups

developed thermal skin injury, infection, nerve palsy or deep venous thrombosis.

General Comment:

There is no difference in pain intensity for any of the follow up days. However, the percentage of patients with nighttimes’ pain that disrupted their sleep was significantly lower on the second postoperative day for the continuous cryotherapy group compared with the ice therapy group. It showed modest benefit in continuous flow, temperature-controlled cryotherapy device versus ice therapy for early nighttimes’ pain control and improved quality of life following routine outpatient knee arthroscopy procedure, with less risk of thermal injury.

Appendices

79

Appendix 3: Levels of Evidences

1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of

bias

1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias

1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias

2++ High quality systematic reviews of case control or cohort or studies

High quality case control or cohort studies with a very low risk of confounding or bias and

a high probability that the relationship is causal

2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and a

moderate probability that the relationship is causal

2- Case control or cohort studies with a high risk of confounding or bias and a significant risk

that the relationship is not causal

3 Non-analytic studies, e.g. case reports, case series

4 Expert opinion

Appendix 4: Grades of Recommendations

At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results

A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; orExtrapolated evidence from studies rated as 1++ or 1+

A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++

Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+

Good Practices Points

Recommended best practice based on the clinical experience of the guideline development group

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Appendices

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1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis)

Not addressed No detail described.

1.10 Where the study is carried out at

more than one site, results are

comparable for all sites


SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias?

Code ++, +, or −

+

2.2 If coded as +, or − what is the likely direction in which

bias might affect the study results?

No detail of randomizing

method, concealment method

and binding method are

described.

2.3 Taking into account clinical considerations, your

evaluation of the methodology used, and the statistical

power of the study, are you certain that the overall effect

is due to the study intervention?

Yes

2.4 Are the results of this study directly applicable to the

patient group targeted by this guideline?

Yes

2.5 Notes. There is no statically significant different between 2 groups in range of motion,

pain scores and need for analgesic. That means there is no significant different in cryocuff

and Robert Jones bandage after TKR

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Appendices

83

1.7 All relevant outcomes are

measured in a standard, valid and

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Well covered - The outcome measurement

used are standard and

reliable.

1.8 What percentage of the individuals

or clusters recruited into each

treatment arm of the study

dropped out before the study was

completed?

5% - Cryo: 1

- EDA: 2

- Control: 0

- Acceptable as < 20%








Code ++, +, or −

+




method, concealment method

and binding method are

described.





Yes



Yes

2.5 Notes. Both Cryo/Cuff and EDA was significantly reduced in morphine used compared

with the control group. No significant difference between groups was noted in subjective

pain, swelling, ROM and function. Cryo/Cuff seems to be a risk-free (1 patient totally

paralyzed in both legs and 1 patient anesthetized in the other leg in EDA group),

well-tolerated, little competence-demanding alternative to EDA in the postoperative pain

management.

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No detail of bin

he study.

imilar patient

haracteristics

tudy.

Pre-op:

Pre-medicate

sedative and

During surgery

Both groups

anesthesia w

and ropivaca

All knees are

through a mi

incision with

parapatellar a

Use tourniqu

and applied f

Before skin c

haemostasis

using diather

No wound drai

Appendic

84

Postoperativ86 patients

on hasn’t state

esearch questi

y stated

but no details

envelopes

nding stated in

ts’

shown in the

ed with a mild

paracetamol

y:

are under spin

with morphine

ain

e approached

idline anterior

h a medial

arthrotomy

uet (300 mmH

for 75 mins

closure,

was controlle

rmy

in used

ces

4

ve .

d

ion

s

n

d

nal

r

Hg)

d

Appendices

85



reliable way

Adequately

addressed

The outcome measurements

used are standard and reliable

in pain, but not mentioned in

the device used in ROM

measurement.





completed?

~3.5% - Cold compression: 2

- EDA: 1

- Acceptable as < 20%








Code ++, +, or −

+




method and binding method

are described.





Yes



Yes

2.5 Notes. Combined cold compression therapy controls pain (use less analgesics), improves

ROM, and may speed up the time for mobilization.

S 4.

SEIn

1

1

1

1

1

1

1

1

I G N M

Morsi, EJournal


.1 The stud

and clea

.2 The assi

treatmen

.3 An adeq

is used

.4 Subjects

‘blind’ a

.5 The trea

are simi

.6 The only

groups i

investig

.7 All relev

measure

reliable

.8 What pe

or cluste

Methodolog

E. (2002). Cof Arthropl


dy addresses a

arly focused q

ignment of su

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quate concealm

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about treatmen

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y difference b

is the treatmen

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ed in a standar

way

ercentage of th

ers recruited i

gy Checkli

Continuous-lasty, 17(6)

AL VALIDITudy…

an appropriate

question.

ubjects to

andomised

ment method

gators are kept

nt allocation

ntrol groups

t of the trial

between

nt under

s are

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he individuals

nto each

ist 2: Cont

flow cold th, 718-722.TY

This crite

e Poorly ad

Not app

Not app

t Not app

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Adequ

addre

s Not add

trolled Tri

herapy after

erion is: R

ddressed

plicable It

st

plicable It

st

plicable A

tr

uately

essed

A

pr

st

p

gr

overed -

-

-

-

uately

essed

T

u

in

th

m

dressed N

ials

r total knee

Remarks:

PICO are not

t is a prospecti

tudy without r

t is a prospecti

tudy without r

All patients rec

reatment.

All patients had

rimary osteoa

taged bilateral

atient will be

roup and cont

All compone

cemented.

All patients w

CPM.

The operatio

or under the

the author us

technique.

And same dr

after surgerie

The outcome m

sed are standa

n pain, but not

he device used

measurement.

No detail descr

Appendic

86

arthroplasty

defined clearl

ive control tri

randomized.

ive control tri

randomized.

ceive the same

d advanced

arthrosis and

l TKRs. Every

the treatment

trol group.

ents were

were placed in

on was done by

supervision o

sing the same

ressing applied

es.

measurements

ard and reliabl

t mentioned in

d in ROM

ribed.

ces

6

y.

ly

ial

ial

e

y

n

y

f

d

le

n

Appendices

87



completed?








Code ++, +, or −

−



The studies was not a

randomized controlled trials





Yes



Yes

2.5 Notes. Continuous-flow cold therapy is advantageous after TKR. It provides greater knee

extension and flexion at week 1 to 2, lower VAS and less analgesic consumption, with no

adverse effect on wound healing.

S 5.

SEIn

1

1

1

1

1

I G N M

Radkow& EaslearthroplAdvance


.1 The stud

and clea

.2 The assi

treatmen

.3 An adeq

is used

.4 Subjects

‘blind’ a

.5 The trea

are simi

Methodolog

wski, C. A., ey, M. E. (20asty: a proses, 16(2), 67: INTERNAucted RCT stu

dy addresses a

arly focused q

ignment of su

nt groups is ra

quate concealm

s and investig

about treatmen

atment and co

ilar at the start

gy Checkli

Pietrobon, R007). Cryotspective ran7-72.

AL VALIDITudy…

an appropriate

question.

ubjects to

andomised

ment method

gators are kept

nt allocation

ntrol groups

t of the trial

ist 2: Cont

R., Vail, T. therapy tempndomized tri

TY This crite

e Well co

Well co

Well co

t Well co

Well co

trolled Tri

P., Nunley,perature difial. Journal

erion is: R

overed P

overed P

p

co

ra

overed A

an

te

cr

overed T

su

cl

p

an

to

ea

overed S

ch

st

ials

, J. A., 2nd,fferences afof Surgical

Remarks:

PICO was clea

Patient assignm

erformed usin

omputer-gene

andomization.

An administrat

nd concealed

emperature in

ryotherapy de

The patients, p

urgeons, resea

linical epidem

erforming the

nalysis (R.P.)

o the treatmen

ach patient.

imilar patient

haracteristics

tudy.

Appendic

88

, Jain, N. B.fter total knel Orthopaed

arly covered.

ment was

ng

erated blocked

.

tive assistant s

the assigned

each

evice.

articipating

arch nurse and

miologist

e statistical

were all blind

nt assigned to

ts’

shown in the

ces

8

., ee dic

d

set

d

ded

Appendices

89

1.6 The only difference between

groups is the treatment under

investigation

Well covered - Follow the standard surgical

technique used by each of

the participating surgeons.

Surgical protocols between

the surgeons are similar.

- Same dressing applied

- Same cryotherapy devices

used on both group except

difference temperature.

- The cryotherapy device was

used continuously during the

patients’ hospital stay and

discontinued upon

discharge.



reliable way

Well covered - All patients were evaluated

in the postoperative period

by the same research nurse.

- Pain: VAS, narcotic

consumption

- Self-reported knee function:

IKDC

- Passive knee ROM: using a

hand goniometer by PT





completed?








SECTION 2: OVERALL ASSESSMENT OF THE STUDY 2.1 How well was the study done to minimise bias? ++

Appendices

90

Code ++, +, or −







Yes



Yes

2.5 Notes. With the colder 45°F cryotherapy temperature following TKR, no improvement

was observed in the short-term postoperative narcotic consumption and pain scores, ROM

and self-reported knee function. No adverse effects were reported with the cryotherapy

treatment.

S 6.

SEIn

1

1

1

1

1

1

1

1

1

I G N M

Smith, Jcontrollepostoper


.1 The stud

and clea

.2 The assi

treatmen

.3 An adeq

is used

.4 Subjects

‘blind’ a

.5 The trea

are simi

.6 The onl

groups i

investig

.7 All relev

measure

reliable

.8 What pe

or cluste

treatmen

dropped

complet

.9 All thein the gwere ra(often intenti

Methodolog

J., Stevens, ed trial comrative total : INTERNAucted RCT stu

dy addresses a

arly focused q

ignment of su

nt groups is ra

quate concealm

s and investig

about treatmen

atment and co

ilar at the start

y difference b

is the treatmen

gation

vant outcome

ed in a standar

way

ercentage of th

ers recruited i

nt arm of the s

d out before th

ted?

e subjects argroups to wandomly allreferred to on to treat a

gy Checkli

J., Taylor, Mmparing com

knee replacAL VALIDITudy…

an appropriate

question.

ubjects to

andomised

ment method

gators are kept

nt allocation

ntrol groups

t of the trial

between

nt under

s are

rd, valid and

he individuals

nto each

study

he study was

re analysed which they located as analysis)

ist 2: Cont

M., & Tibbempression bacement surgTY

This crite

e Adequ

addre

Well co

Not add

t Not add

Well co

Well co

Adequ

addre

s Not add

Not add

trolled Tri

ey, J. (2002andaging an

gery. Orthop

erion is: R

uately

essed

overed

dressed N

m

dressed N

th

overed S

ch

st

overed O

af

uately

essed

T

u

in

th

m

dressed N

dressed N

ials

2). A randomnd cold therpaedic Nurs

Remarks:

Outcome is no

Randomize by

No detail of co

method is desc

No detail of bin

he study.

imilar patient

haracteristics

tudy.

Only different

fter OT

The outcome m

sed are standa

n pain, but not

he device used

measurement.

No detail descr

No detail descr

Appendic

91

mized, rapy in sing, 2, 61-6

ot stated clear

y coin toss.

oncealment

cribed.

nding stated in

ts’

shown in the

at the first day

measurements

ard and reliabl

t mentioned in

d in ROM

ribed.

ribed.

ces

1

66.

rly

n

y

le

n

Appendices

92






Code ++, +, or −

+



No detail of concealment

method and binding method

are described.





Yes



Yes

2.5 Notes. No difference between the two management techniques for pain scores and swelling

in the first 48 hours of the postoperative period. A cost benefit analysis showed the

compression bandaging is cheaper and less labor intensive to manage than the cold

therapy.

S 7.

SEIn

1

1

1

1

1

1

1

1

1

I G N M

Woolf, SComparsimple iKnee Su


.1 The stud

and clea

.2 The assi

treatmen

.3 An adeq

is used

.4 Subjects

‘blind’ a

.5 The trea

are simi

.6 The only

groups i

investig

.7 All relev

measure

reliable

.8 What pe

or cluste

treatmen

dropped

complet

.9 All thein the gwere ra(often intenti

Methodolog

S. K., Barfierison of a coicing regimeurgery, 21(1: INTERNAucted RCT stu

dy addresses a

arly focused q

ignment of su

nt groups is ra

quate concealm

s and investig

about treatmen

atment and co

ilar at the start

y difference b

is the treatmen

gation

vant outcome

ed in a standar

way

ercentage of th

ers recruited i

nt arm of the s

d out before th

ted?

e subjects argroups to wandomly allreferred to on to treat a

gy Checkli

eld, W. R., Montinuous teen following), 15-19.

AL VALIDITudy…

an appropriate

question.

ubjects to

andomised

ment method

gators are kept

nt allocation

ntrol groups

t of the trial

between

nt under

s are

rd, valid and

he individuals

nto each

study

he study was

re analysed which they located as analysis)

ist 2: Cont

Merrill, K. Demperature-g outpatient

TY This crite

e Well co

Adequ

addre

Not add

t Not add

Poorly ad

Adequ

addre

Adequ

addre

s ~11.6

Not add

trolled Tri

D., & McB-controlled ct knee arthr

erion is: R

overed

uately

essed

-

-

-

dressed N

m

dressed N

th

ddressed N

ch

uately

essed

uately

essed

P

67% -

-

-

dressed N

ials

ryde, A. M.cryotherapyroscopy. The

Remarks:

PICO was cle

Randomizatio

record numbe

Even no. → C

Odd no. → Ic

No detail of co

method is desc

No detail of bin

he study.

No specific pat

haracteristics

Pain: 5-points V

- Ice therap

quit or exclud

- CTC: 4 pa

excluded

- Acceptabl

No detail descr

Appendic

93

., Jr. (2008)y device to ae Journal of

early stated

on by hospital

ers

CTC

ce therapy

oncealment

cribed.

nding stated in

tient

described.

VAS

py: 3 patients

ded

atients quit or

le as < 20%

ribed.

ces

3

. a f

l

n

r

Appendices

94




Not applicable In one center only


Code ++, +, or −

+



No detail of concealment

method, binding method and

patient characteristics are

described.





Yes



Yes

2.5 Notes. There is no difference in pain intensity for any of the follow up days. However, the

percentage of patients with nighttimes’ pain that disrupted their sleep was significantly

lower on the second postoperative day for the continuous cryotherapy group compared

with the ice therapy group. It showed modest benefit in continuous flow,

temperature-controlled cryotherapy device versus ice therapy for early nighttimes’ pain

control and improved quality of life following routine outpatient knee arthroscopy

procedure, with less risk of thermal injury.

Appendices

95

Appendix 6: Summary of Levels of Evidences

Bibliographic

Citation Study Type

Levels of

Evidence % of criteria fulfilled

1. Gibbons, Solan,

Ricketts, &

Patterson

(2001)

RCT 1 + 40%

2. Holmström &

Härdin (2005) RCT 1 + 50%

3. Kullenberg,

Ylipää,

Söderlund, &

Resch (2006)

RCT 1 + 60%

4. Morsi (2002) PCT 1 – 30%

5. Radkowski, et

al. (2007) RCT 1 ++ 70%

6. Smith, Stevens,

Taylor, &

Tibbey (2002)

RCT 1 + 50%

7. Woolf, et al.

(2008) RCT 1 + 50%

Appendices

96

Appendix 7: Criteria for Evaluating the Implementation Potential of an Innovation under Scrutiny

Transferability of the Findings

1. Will the innovation “fit” in the proposed setting?

2. How similar are the target population in the research and that in the new setting?

3. Is the philosophy of care underlying the innovation fundamentally different from the philosophy prevailing in the

practice setting? How entrenched is the prevailing philosophy?

4. Is there a sufficiently large number of clients in the practice setting who could benefit from the innovation?

5. Will the innovation take too long to implement and evaluate?

Feasibility

1. Will nurses have the freedom to carry out the innovation? Will they have the freedom to terminate the innovation

if it is considered undesirable?

2. Will the implementation of the innovation interfere inordinately with current staff functions?

3. Does the administration support the innovation? Is the organizational climate conducive to research utilization?

4. Is there a fair degree of consensus among the staff and among the administrators that the innovation could be

beneficial and should be tested? Are there major pockets of resistance or uncooperativeness that could undermine

efforts to implement and evaluate the innovation?

5. To what extent will the implementation of the innovation cause friction within the organization? Does the

utilization project have the support and co-operation of department outside the nursing department?

6. Are the skills needed to carry out the utilization project (both the implementation and the clinical evaluation)

available in the nursing staff? If not, how difficult will it be to collaborate with or to secure the assistance of

others with the necessary skills?

7. Does the organization have the equipment and facilities necessary for the innovation? If not, is there a way to

obtain the needed resources?

8. If nursing staff need to be released from other practice activities to learn about and implement the innovation,

what is the likelihood that this will happen?

9. Are appropriate measuring tools available for a clinical evaluation of the innovation?

Cost/Benefit Ratio of the Innovation

1. What are the risks to which clients would be exposed during the implementation of the innovation?

2. What are the potential benefits that could result from the implementation of the innovation?

3. What are the risks of maintaining current practices (i.e. the risks of not trying the innovation)?

4. What are the material costs of implementing the innovation? What are the costs in the short term during

utilization, and what are the costs in the long run, if the change is to be institutionalized?

5. What are the material costs of not implementing the innovation (i.e. could the new procedure result in some

efficiencies that could lower the cost of providing service)?

6. What are the potential non-material costs of implementing the innovation to the organization (e.g. lower staff

morale, staff turnover, and absenteeism)?

7. What are the potential non-material benefits of implementing the innovation (e.g. improved staff morale,

improved staff recruitment)?

Appendices

97

Appendix 8: Cryotherapy Protocol Flow Chart

R2.1: Apply cryocuff immediately after surgery

Preoperative Stage:

Intra-operative Stage:

Early Postoperative Stage

Middle Postoperative Stage

Late Postoperative Stage:

R1.1: Use cryocuff as a mean to provide continuous compression cryotherapy

R2.3: Place cryocuff on the anterior part of knee as well as leave patella and popliteal space free of pressure

R2.2: Place the cryocuff on a light dressing wound

Cryocuff Management R3.1: Keep cryocuff continuously on affected knee at least 48 hours

after operation

Regular Assessment

R3.4: To evaluate pain intensity R3.5: To prevent complication

R4.1: Disconnect cryocuff system with the cuff remained on the knee during mobilization

R5.1: Apply intermitted ice pack regimen after removal of cryocuff

R3.2: Keep temp at 7°C – 15°C R3.3: Re-chill regularly

Regular Assessment (R3.4 – R3.5)

Appendices

98

Appendix 9: Gannt Chart of Implementing the Protocol

Week 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 37 39 40 41 42 43 44 45

Preparation:

1. Searching evidences

2. Data summary and synthesis

3. Protocol development

4. Cryotherapy team formation

Pilot Study:

1. Communication with stakeholders

2. Training staff

3. Trial implementation

4. Evaluation and modification

Implementation:

Evaluation:

Appendices

99

Appendix 10: Pain Management Record Chart

Appendices

100

Appendix 10: Pain Management Record Chart (Cont’d)

Appendices

101

Appendix 11: Knee Circumferences Record Chart

Hospital Authority TSEUNG KWAN O HOSPITAL

ORTHOPAEDIC & TRAUMATOLOGY

Knee Circumferences Record Chart

Please Use Block Letter or Affix Label

Hospital No:____________Name:_________________________I.D. No:________Sex:____ Age:____Dept:_____ Team:___ Ward/Bed:__

OT

Day Date Time

Affected Knee (in mm)

(Left / Right)*

Non-Affected Knee (in mm)

(Left / Right)*

Staff

Signature

1

2

3

4

5

6

7

8

9

10

11

12

13

14

* Circle as appropriate

Appendices

102

Appendix 12: Range of Motion Record Chart

Hospital Authority TSEUNG KWAN O HOSPITAL

ORTHOPAEDIC & TRAUMATOLOGY

Range of Motion Record Chart

Please Use Block Letter or Affix Label

Hospital No:____________Name:_________________________ I.D. No:_________ Sex:___ Age:____

Dept:______ Team:____ Ward/Bed:___

OT

Day Date Time

Affected _______(area)

(Left / Right)*

Non-Affected _______(area)

(Left / Right)* Staff

SignatureMax

Active

Extension

Max

Active

Flexion

Max

Passive

Extension

Max

Passive

Flexion

Max

Active

Extension

Max

Active

Flexion

Max

Passive

Extension

Max

Passive

Flexion

1

2

3

4

5

6

7

8

9

10

11

12

13

14

* Circle as appropriate

References

103

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