National Physiotherapy Research Network
Midlands Hub
July 8th 2009
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Midlands NPRN Contacts
Esther Williamson – Warwick University
Sue Kelly – Birmingham University
Chris Carpenter – Coventry University
Nikky Clague – Leicester University
Managing Injuries of Neck Trial
(MINT)
Results
3
Background
Identified as a priority and commissioned through the NIHR HTA in 2003
Research question:
“What is the effectiveness and cost effectiveness of active treatment for whiplash?”
4
Whiplash Mechanism of injury – acceleration / deceleration usually in the frontal plane
Whiplash Associated Disorders
The signs and symptoms experienced following a whiplash injury
WAD Grade 0 No neck complaints or signs
WAD Grade I Complaint of pain, stiffness or tenderness, but no physical signs.
WAD Grade II Complaint of pain, stiffness or tenderness, and musculoskeletal signs (decreased range of motion, point tenderness etc).
WAD Grade III Complaint of pain, stiffness or tenderness and neurological signs (decreased or absent deep tendon reflexes, weakness and sensory deficits). Could also have musculoskeletal signs.
WAD Grade IV Fracture or dislocation
Late whiplash syndrome
The presence of pain, restriction of motion or other symptoms six months or more after a whiplash injury, sufficient to hinder return to normal activities such as driving, usual occupation and leisure
Acute WAD
Quebec Task Force 1995
McClune et al 2002; Verhagen et al 2004
Hurwitz et al 2008 – Bone and Joint Decade 2000-2010 Task Force on Neck Pain
Since 1980;
15 reports of non-invasive interventions
2 of invasive interventions
Acute whiplash BJD Task Force
“Despite an explosion of the neck-pain literature including several methodologically sound studies in the past decade, there remains limited or conflicting evidence for most of the therapies commonly given to WAD patients”
15 studies compared to usual care, placebo, sham
- 7 equivalent or worse
- 8 better
Trial Management Team
Prof S Lamb – Clinical Trials/PhysiotherapyDr Simon Gates – Senior Research FellowMark Williams – Clinical Trial co-ordinatorEsther Williamson - Research FellowEmma Withers – Trial Co-ordinatorProf M Underwood – MusculoskeletalProf M Cooke – ED Prof D Ashby - StatisticianShahrul Mt Isa - StatisticianDr S Joseph – Psychologist/TraumaEmanuela Castelnuovo - Health Economics
Aims of MINT
1. To estimate the clinical effectiveness of a stepped care approach over a 12 month period after an acute injury.
2. To estimate the costs of each strategy including treatment and subsequent health care costs over a period of 12 months and to estimate cost effectiveness.
Study Design
Stage 1: Emergency Department Treatment:
Psycho educational booklet
(Whiplash Book)
versus
Usual ED Advice
Stage 2: Physiotherapy Management:
Specially designed early intervention by a physiotherapist
Versus
Advice session only
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Study design - overview
Acute Whiplash Injury presents to ED N= 12 clusters (n≈ 3000 participants)
Whiplash Book advice (WBA)N= 6 clusters
Review and randomisation in research clinic
Physiotherapy & WBA
n=150
Re-enforcement
of WBAn=150
Usual Care Advice (UCA)N= 6 clusters
Review and randomisation in research clinic
Physiotherapy & UCA
n=150
Re-enforcement
of UCAn=150
Outcomes
• Followed up at 4, 8 and 12 months post injury• Postal questionnaire:
Disease specific measure - Neck Disability Index
Generic Health Related Quality of Life (SF12)
Health economics – (health care costs NHS, individual, third party; work; out of pocket expenses; Insurance payouts)
• Qualitative study – interviews of purposive sample 20 pts
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Eligibility
Sustained a whiplash injury within the last 6 weeks
WAD Grade I – III with neck symptoms
Over 18 years old
No fractures/dislocations of the spine or other bones.
No head injuries with more than a transient loss of consciousness or GSC ≤ 12 at any stage.
Not admitted
No severe psychiatric illness
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Stage 1: ED training
Usual Care Advice ED staff received training primarily about referring patients to trial
In contrast to
Whiplash Book Advice ED staff received more extensive training to promote key messages
The Whiplash Book
• Positive messages about prognosis, promoting the message that pain is nothing to worry about.
• Promotes early return to normal activities and work.
• Make recommendations about physical activity, exercise and self-management of symptoms.
• Advice against using a collar• Does not include information on pursuing claims
or sponsorship from solicitors.
Trial progress
Developed trial materials November 2004
Pilot study completed August 2005
Launched main trial December 2005
Recruitment completed October 2007
Follow up completed December 200816
12 NHS Trusts
Usual Care Advice
15 Emergency Departments (ED’s) Whiplash Book Advice
Eligible & Enrolled Eligible & Enrolled
1598 2253Median cluster size = 265
(range 55-431)Median cluster size = 332
(range 130-711)
Followed up = 1488 (93%) Followed up = 2042 (91%)
Lost = 115 Lost = 198
Withdrawn = 39 Withdrawn = 46Median cluster size = 248
(range 50-401)Median cluster size = 306
(range 118-642)
Followed up = 1295 (81%) Followed up = 1774 (79%)
Lost = 106 Lost = 171
Withdrawn = 37 Withdrawn = 36Median cluster size = 217
(range 45-349)Median cluster size = 282
(range 113-524)
Followed up = 1175 (74%) Followed up = 1570 (70%)
Lost = 152 Lost = 208
Withdrawn= 22 Withdrawn = 17Median cluster size = 196
(range 38-323)Median cluster size = 262
(range 102-437)
Followed up = 1127 (71%) Followed up = 1577 (70%)Median cluster size = 199
(range 40-305)Median cluster size = 259
(range 91-474)
4 months
8 months
12 months
2 weeks
Results : Stage 1Characteristics (n=3851)
UCA WBA
Number enrolled 1598 2253
Gender – Males 666 (42%) 995 (44%)
Age in years, Mean (SD) 37 (13) 37 (13)
Ethnic Group
White 1336 (84%) 1586 (70%)
Mechanism of injury
Road Traffic Accident 1495 (94%) 2127 (94%)
Location of pain
C-spine only 1046 (65%) 1365 (61%)
Pain intensity (/10), mean (SD) 4.9 (1.9) 5.3 (1.9)
History
Previous neck problems 77 (4.8%) 119 (5.3%)
WAD grades³
I: Complaints of pain, stiffness or tenderness, no physical signs
883 (55%) 1205 (53%)
II: Complaint of pain, stiffness or tenderness, musculoskeletal signs
662 (41%) 997 (44%)
III: Complaint of pain, stiffness or tenderness, neurological signs
53 (3.3%) 51 (2.3%)
Results – Stage 1Primary Outcome - NDI
10
12
14
16
18
20
22
24
4m follow up 8m follow up 12m follow up
UCA
WBA
Ne
ck D
isa
bili
ty I
nd
ex
(%)
Points are offset for visual purposes only
Results – Stage 1 Secondary Outcome – SF12
35
40
45
50
Baseline 4m follow up 8m follow up 12m follow up
UCA
WBA
SF
-12v
1 M
CS
Points are offset for visual purposes only
35
40
45
50
Baseline 4m follow up 8m follow up 12m follow up
UCA
WBA
SF
-12v
1 P
CS
Points are offset for visual purposes only
Results – stage 1 Qualitative Study
From the accounts given, participants received the same verbal advice at both WB and UC centres.
Those who received the Whiplash Book were more likely to have started doing the exercises on their own.
However, some participants in both groups expressed hesitation about doing exercises without further guidance or reassurance due to worry of doing damage or the wrong thing.
Participants appeared to mainly focus on the exercises suggesting that those receiving the WB did not utilise the other information contained in it.
Stage 1 - Conclusions
• The Whiplash Book delivered in an ED setting was no more effective than the usual care that is delivered.
• No change of practice but is this enough???
Questions
STAGE 2
Study design - overview
Acute Whiplash Injury presents to ED N= 12 clusters (n≈ 3000 participants)
Whiplash Book advice (WBA)N= 6 clusters
Review and randomisation in research clinic
Physiotherapy & WBA
n=150
Re-enforcement
of WBAn=150
Usual Care Advice (UCA)N= 6 clusters
Review and randomisation in research clinic
Physiotherapy & UCA
n=150
Re-enforcement
of UCAn=150
Stage 2: Physiotherapy
Inclusion criteria:
Still experiencing symptoms approximately three weeks after attendance at the ED
Had symptoms in the last 24 hours
WAD grade I-III at this time
Did not have any contra-indications to physiotherapy: central cord compression or upper motor neuron lesion, complete nerve root compression or lower motor neuron lesion, suspected vascular injury or haemorrhagic event.
Physiotherapy package
An assessment
Up to 6 treatment sessions
Designed to be delivered over approximately 8 week period
Development of physiotherapyintervention
Patient group:Whiplash associated disorders
I-III Phase of recovery:
Sub-acute – referred for treatment between 3 and 6 weeks post
injury
Current physiotherapy
practice
Risk factors for poor outcome following a
whiplash injury
Acceptable to clinicians
Existing clinical practice
guidelines
The setting: deliverable in
the NHS
Standardised and reproducible to allow
evaluation
Current evidence base: effective
treatments
Intervention design
considerations
Theoretical basis for physiotherapy intervention
Risk Factor Modification
“ Variable with significant association with a clinical outcome”
Identify risk factors
Target treatments to modify these factors
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Physical risk factors
High initial pain and disability
The literature also suggested that addressing reduced ROM, altered muscle function and control may be beneficial.
Psychological risk factors
Low self-efficacy
Post traumatic stress reaction
The literature also suggested that addressing fear avoidance, catastrophising, coping and distress may also be beneficial.
Physiotherapy package
Integrated approach to the management of both physical and psychological factors utilising three main components:
1. manual therapy
2. exercise
3. psychological strategies and self-management advice.
Control Intervention
40 min session
No hands on
Reinforcement of ED advice
Questions and Answers
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Treatments delivered (n=599)Advice
N (% of stage 1)Physiotherapy
N (% of stage 1)
Usual Care AdviceCoventry & Rugby 30 (8%) 31 (8%)Frenchay 18 (8%) 16 (7%)Cheltenham & Gloucester 40 (9%) 39 (9%)Redditch 24 (8%) 25 (8%)Kettering 15 (7%) 14 (7%)Stoke Mandeville 3 (5%) 5 (9%)
Whiplash Book AdviceHeartlands & Solihull 47 (7%) 48 (7%)Selly Oak 29 (6%) 27 (5%)John Radcliffe Hospital 21 (9%) 23 (10%)Warwick 25 (10%) 25 (10%)Gwent 14 (11%) 15 (12%)Chester 21 (5%) 19 (5%)
Attendance rates
Physiotherapy Package (n=300)
Advice session (n=299)
Failed to attend any appointments
34(11%) 60 (20.1%)
Attended for assessment only
26 (9%) N/A
Partial completion of treatment
45 (15%) N/A
Completed treatment 201(67%) 239 (79.9%)
Treatments deliveredNumbers of treatment
Physiotherapy Package
Range = 0 to 23 (Median = 3.0, IQR = 1.0 -5.0)
14 (4.7%) patients receiving greater than the recommended six treatment sessions.
Timings of treatment:
Physiotherapy package:
63% of patients were seen within 2 weeks of referral.
91% were seen within 4 weeks of referral
62% of patients completed their treatment in the recommended eight weeks
87% of patients completed within 12 weeks
Physiotherapy delivered
Combinations of treatments deliveredNumber of patients receiving the treatment (%)
Manual therapy, exercises and psychological strategies
190 (73%)
Exercises and psychological strategies 45 (18%)
Manual therapy and psychological strategies 10 (4%)
Manual therapy and exercises 9 (4%)
Manual therapy only 2 (1%)
Exercises only 2 (1%)
Psychological strategies only 1 (0.5%)
Timings of treatment:
Advice session:
53% of those receiving the advice session were seen within 2 weeks of referral.
86% attended within 4 weeks
Advice givenContents of advice session Number of
patients (%)Assessed ROM 232 (97)Reviewed exercises given in the ED 228 (95)Advised to see their GP if they had ongoing problems 220 (92)Postural or positioning advice 200 (83.5)Advice re: pain control or medication use 185 (77.5)Reinforced the “hurt does not equal harm” message¹ 121(50.5)Advice re: graded return to activities, return to work or staying active¹
119 (50)
Reassurance¹ 119 (50)Progressed exercises within the guidelines of WB¹ 108 (45)Neurological examination 87 (36.5)Relaxation techniques¹ 82 (34.5)Advice re: collar 56 (22)Other advice 25 (8.4)Referred on due to serious complication 2 (0.8)
Follow up
Follow up rates
4 month follow up 88%8 month follow up 89%12 month follow up 86%
Results – stage 2 Characteristics
More Females (64%)
Mean age 40 yrs
WAD grades: I = 46%
II = 49%
III = 4%
Results – Step 2 – NDI scores
15.0
20.0
25.0
30.0
35.0
40.0
45.0
50.0
Baseline 4m follow up 8m follow up 12m follow up
Advice Physio
ND
I o
vera
ll sc
ore
(%
)
Points are offset for visual purposes only
Results – Step 2
• Physiotherapy intervention provided a greater reduction in NDI scores (by about 3% points) at 4 month follow up.
• The difference was not retained at 8 and 12 month follow-ups.
• This symptomatic relief may be very important to the individual but was not demonstrated to be cost-effective at a health service level.
Results – Step 2 – SF-12
35
40
45
50
Baseline 4m follow up 8m follow up 12m follow up
Advice
Physio
SF
-12v
1 M
CS
Points are offset for visual purposes only
35
40
45
50
Baseline 4m follow up 8m follow up 12m follow up
Advice
Physio
SF
-12v
1 P
CS
Points are offset for visual purposes only
Levels of disability
4 monthsN(%)
8 monthN (%)
12 monthsN(%)
No disability 66(13.5) 120(25.2) 151(32.9)
Mild disability 215(44.0) 199(41.7) 172(37.5)
Moderate disability 142(29.0) 114(23.9) 102(22.2)
Severe disability 51(10.4) 35(7.3) 28(6.1)
Complete disability 15(3.1) 9(1.9) 6(1.3)
Total 489(100) 477(100) 459(100)
Qualitative study – stage 2
Participants receiving the Physiotherapy Package highlighted the helpfulness of the guidance and reassurance received, particularly in relation to undertaking exercises, and the manual therapy.
A minority of those receiving the physiotherapy package felt they needed more treatment.
Qualitative study – stage 2
The advice session also provided guidance and reassurance that enabled participants to manage their injury and in particular undertake the exercises suggested in the written advice.
This single session was sufficient for many participants especially when access was relatively quick, although, some participants felt they would have benefited from a follow up session
Overall conclusions
A physiotherapy package based on manual therapy, exercise and psychological strategies and self-management advice results in short term benefit, but no difference in longer term outcomes.
At the population level there is residual disability at 12 months, this needs more careful exploration.
Non-invasive Interventions for Whiplash-Associated Disorders
Likelihood of Being Helpful in the Short Term:
Likely helpful (worth considering)
Possibly helpful (might consider)
Likely not helpful (not worth considering
Not enough evidence to make determination
1. Educational video2. Mobilization3. Exercises4. Mobilization and
exercises
1. Pulsed electromagnetic therapy
1. Pamphlet/neck booklet alone
2. Collars3. Passive modalities
(heat, cold, diathermy, hydrotherapy)
4. Referral to fitness or rehab program
5. Frequent early health-care use
6. Methylprednisolone
1. Manipulation2. Traction 3. NSAIDS4. Other drugs
The Bone and Joint Decade 2000 –2010 Task Force on Neck Pain and Its Associated Disorders
What do these results mean?
NHS manager
Clinician
Whiplash researcher
Patient
ReferencesHurwitz et al (2008) Treatment of neck pain: non invasive interventions:
results of the bone and joint decade 2000-2010 Task Force on Neck Pain and it’s associated disorders. Spine 2008: 33(4 suppl):s123-52.
Williamson et al (2009) Development and delivery of a physiotherapy intervention for the early management of whiplash injuries: The Managing Injuries of Neck Trial (MINT) Intervention. Physiotherapy 95(1):15-23
Williamson et al (2008) A systematic literature review of psychological factors and the development of late whiplash syndrome. Pain 135(1-2): 20-30
Williams et al (2007) A systematic literature review of physical factors and the development of late whiplash syndrome. Spine 32(25): E764-E780
Lamb et al (2007) Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders. BMC Musculoskeletal Disorders 2007, 8:7
MINT Incentive Study
Results
Background
Postal Questionnaires are commonly used in RCT’s to collect data
Non-response -> missing data -> bias?Postal and telephone chasing is labour
intensiveMonetary incentives have been shown to be
effective in non-healthcare settingsEffectiveness in healthcare settings
uncertain…
Methods
RCT of a £5 gift voucher vs. no gift voucher
Eligibility: MINT Participants who were sent a follow-up Q at either 4 or 8 months post injury
Questionnaire 15 pages with 49 questions
Standard Chasing strategy was used
Results
2144 randomised (1070:1074)
Higher proportion of Q’s returned in incentive group (810 vs.738) (RR 1.10 [1.05, 1.16])
Higher proportion of Q’s returned without chasing in incentive group (560 vs.493) (RR 1.14 [1.05, 1.24])
Cost £67.29 per additional questionnaire returned
Conclusions
Monetary incentives may be an effective way to increase proportion of postal questionnaires returned and minimise loss to follow-up in healthcare trials.
Further studies needed to investigate the effect of size of incentive, conditional vs unconditional and timing of incentive.
Questions