Prior Authorization Review Panel MCO Policy Submission A ... · Aetna considers dynamic splinting devices for the knee, elbow, wrist, finger, or toe medically necessary durable medical

Prior Authorization Review PanelMCO Policy Submission

A separate copy of this form must accompany each policy submitted for review. Policies submitted without this form will not be considered for review.

Plan: Aetna Better Health Submission Date:07/01/2019

Policy Number: 0405 Effective Date: Revision Date: 06/24/2016

Policy Name: Mechanical Stretching Devices for Contracture and Joint Stiffness

Type of Submission – Check all that apply: New Policy Revised Policy* Annual Review – No Revisions

*All revisions to the policy must be highlighted using track changes throughout the document. Please provide any clarifying information for the policy below:

CPB 0405 Mechanical Stretching Devices for Contracture and Joint Stiffness

Clinical content was last revised on 06/24/2016 . Additional non-clinical updates were made by Corporate since the last PARP submission, as documented below.

Update History since the last PARP Submission:

03/12/2019-This CPB has been updated with additional coding.

Name of Authorized Individual (Please type or print):

Dr. Bernard Lewin, M.D.

Signature of Authorized Individual:

http://www.aetna.com/cpb/medical/data/400_499/0405.html

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(https://www.aetna.com/)

Mechanical Stretching Devices forContracture and Joint Stiffness

Clinical Policy Bulletins Medical Clinical Policy Bulletins

Policy History

Last Revi

ew

03/12/2019

Effective: 04/04/200

Next Review:

04/11/2019

Review Hi

story

Definitions

Additional Information

Number: 0405

Policy *Please see amendment for Pennsylvania Medicaid at the end of this CPB.

Dynamic Splinting Devices

Aetna considers dynamic splinting devices for the knee, elbow, wrist, finger, or toe

medically necessary durable medical equipment (DME) if either of the following two

selection criteria is met:

1. As an adjunct to physical therapy in members with documented signs and

symptoms of significant motion stiffness/loss in the sub-acute injury or post-

operative period (i.e., at least 3 weeks after injury or surgery); or

2. For members who have a prior documented history of motion stiffness/loss in a

joint, have had a surgery or procedure done to improve motion to that joint, and

are in the acute post-operative period following a second or subsequent surgery

or procedure.

Note: Dynamic splinting systems include, but are not limited to, such products as

Advance Dynamic ROM, Dynasplint, EMPI Advance Dynamic ROM, LMB Pro-glide,

Pro-glide Dynamic ROM, SaeboFlex, SaeboReach, Stat-A-Dyne, and Ultraflex.

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Note: The SaeboMas dynamic mobile arm support system is considered

experimental and investigational because of insufficient published evidence of its

clinical value.

Aetna considers the prophylactic use of dynamic splinting experimental and

investigational in the management of chronic contractures (no significant change in

motion for a 4-month period) and joint stiffness due to joint trauma, fractures, burns,

head and spinal cord injuries, rheumatoid arthritis, multiple sclerosis, muscular

dystrophy or cerebral palsy because of insufficient evidence in the peer-reviewed

literature. However, if surgery is being performed for a “chronic” condition, the use

of a dynamic splinting system may be considered medically necessary if the

member meets the selection criteria stated above.

Aetna considers the use of dynamic splinting experimental and investigational for

the following indications (not an all-inclusive list) because there is a lack of scientific

evidence regarding its effectiveness for these indications.

Carpal tunnel syndrome

Cerebral palsy

Foot drop associated with neuromuscular diseases

Head and spinal cord injuries

Improvement of outcomes following botulinum toxin injection for treatment

of limb spasticity

Injuries of the ankle, and shoulder

Multiple sclerosis

Muscular dystrophy

Plantar fasciitis

Rheumatoid arthritis

Stroke

Trismus

Flexionators and Extensionators

Aetna considers patient-actuated serial stretch (PASS) devices (e.g., the

ERMI Knee/Ankle flexionator, the ERMI Shoulder flexionator, the ERMI Elbow

extensionator, the ERMI Knee extensionator, the ERMI MPJ extensionator, JAS EZ

(ankle, elbow, finger, knee extension, knee flexion, pronation/ supination, shoulder,

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toe and wrist), and knee extension devices (e.g., the Elite Seat) experimental and

investigational because of insufficient scientific evidence of the effectiveness of

these devices.

Joint Active Systems (JAS) Splints

Aetna considers JAS splints (e.g., JAS Elbow, JAS Shoulder, JAS Ankle, JAS

Knee, JAS Wrist, and JAS Pronation-Supination) experimental and investigational

because there is insufficient evidence in the peer-reviewed published medical

literature concerning their effectiveness.

Aetna considers the use of the EZ Turnbuckle orthosis (JAS orthosis) after open

reduction internal fixation (ORIF) for radial head fracture experimental and

investigational because its effectiveness has not been established.

Background

Mechanical stretching devices differ from continuous passive motion devices in that

they are nonmotorized and include the following types: low-load prolonged-duration

stretch (LLPS) devices, patient-actuated serial stretch (PASS) devices and static

progressive stretch (SPS) devices. Mechanical stretching devices are generally

proposed as an adjunct treatment to PT and/or exercise.

LLPS devices, also referred to as dynamic splinting, permit active and

passive motion with elastic traction within a limited range and maintain a

set level of tension by means of incorporated springs. Examples of LLPS

devices include, but may not be limited to, Advance Dynamic ROM,

Dynasplint, EMPI Advance Dynamic ROM, Proglide Advance Dynamic ROM,

LMB Pro-Glide, SaeboFlex, SaeboReach, Stat-A-Dyne and Ultraflex.

PASS devices are purported to permit active and passive motion with elastic

traction within a limited range, but also provide a low- to high-level load to

the joint using pneumatic, hydraulic or tensioning systems that can be

adjusted by the individual. Examples of PASS devices include, but may not

be limited to, Elite Seat, ERMI Elbow Extensionater, ERMI Knee

Extensionater, ERMI Knee/Ankle Flexionater and ERMI Shoulder Flexionater,

JAS EZ Systems (ankle, elbow, finger, knee extension, knee flexion,

pronation/supination, shoulder, toe and wrist).

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SPS devices hold the joint in a set position but are purported to allow for

manual modification of the joint angle without exerting stress on the tissue

unless the angle is set to the joint’s limitations. While these devices allow for

movement (passive or active) within a limited range, the motion is free and

does not provide elastic traction. Examples of SPS devices include, but may

not be limited to, Joint Active Systems (JAS) Splints (eg, JAS Ankle, JAS Elbow,

JAS Knee, JAS Pronation-Supination, JAS Shoulder, JAS Wrist).

Jaw mobility mechanical stretching devices are suggested for use in the

treatment of temporomandibular joint (TMJ) disorders, trismus or other

conditions in which jaw movement is limited. Examples of this type of

mechanical stretching device include, but may not be limited to, TheraBite

Jaw Motion Rehabilitation System, Dynasplint Trismus System or Orastretch.

Dynamic Splinting Systems

Dynamic splinting systems are spring-loaded, adjustable devices designed to

provide low-load prolonged stretch while patients are asleep or at rest. Dynamic

splinting units (for both extension as well as flexion) are available for elbow, wrist,

fingers, knee, ankle and toes. These units are being marketed for the treatment of

joint stiffness due to immobilization or limited range of motion (ROM) as a

consequence of fractures, dislocations, tendon and ligament repairs, joint

arthroplasties, total knee replacements, burns, rheumatoid arthritis, hemophilia,

tendon releases, head trauma, spinal cord injuries, cerebral palsy (CP), multiple

sclerosis, and other traumatic and non-traumatic disorders.

Dynamic splinting is commonly used in the post-operative period for the prevention

or treatment of motion stiffness/loss in the knee, elbow, wrist or finger. It is not

generally used in other joints such as the hip, ankle or foot.

Product names commonly encountered on the market for dynamic splinting include:

Dynasplint™, Ultraflex™, LMB Pro-glide™, EMPI Advance™ and SaeboFlex™.

The SaeboFlex has been promoted for use in rehabilitation in persons with

hemiplegia following cerebrovascular accident. However, there is no peer-reviewed

published medical literature of the effectiveness of the device for this indication.

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Goodyear-Smith and Arroll (2004) undertook a literature review to produce evidence-

based recommendations for non-surgical family physician management of carpal

tunnel syndrome (CTS). These investigators assessed 2 systematic reviews, 16

randomized controlled trials, and 1 before-and-after study using historical controls. A

considerable percentage of CTS resolves spontaneously.

There is strong evidence that local corticosteroid injections, and to a lesser extent

oral corticosteroids, give short-term relief for CTS sufferers. There is limited

evidence to indicate that splinting, laser-acupuncture, yoga, and therapeutic

ultrasound may be effective in the short-to-medium term (up to 6 months).

Graham et al (2004) evaluated the role of steroid injections combined with wrist

splinting for the management of CTS. A total of 73 patients with 99 affected hands

were studied. Patients presenting with known medical causes or muscle wasting

were excluded. Diagnosis was made clinically and electrodiagnostic studies were

performed only when equivocal clinical signs were present. Each patient received

up to 3 betamethasone injections into the carpal tunnel and wore a neutral-position

wrist splint continuously for 9 weeks. After that period, symptomatic patients

received an open carpal tunnel release, and those who remained asymptomatic

were followed-up regularly for at least 1 year. Patients who relapsed were

scheduled for surgery. At a minimum follow-up of 1 year, 7 patients (9.6 %) with 10

affected hands (10.1 %) remained asymptomatic. This group had a significantly

shorter duration of symptoms (2.9 months versus 8.35 months; p = 0.039, Mann-

Whitney test) and significantly less sensory change (40 % versus 72 %; p = 0.048,

Fisher's exact test) at presentation when compared with the group who had

surgery. It is concluded that steroid injections and wrist splinting are effective for

relief of CTS symptoms; but have a long-term effect in only 10 % of patients.

In a systematic review, Larson and Jerosch-Herold (2008) examined the clinical

effectiveness of post-operative splinting after surgical release of Dupuytren's

contracture. Studies were included if they met the following inclusion criteria:

prospective or retrospective, experimental, quasi-experimental or observational

studies investigating the effectiveness of static or dynamic splints worn day and/or

night-time for at least 6 weeks after surgery and reporting either individual joint or

composite finger range of motion and/or hand function. The methodological quality

of the selected articles was independently assessed by the two authors using the

guidelines for evaluating the quality of intervention studies developed by

McDermid. Four studies, with sample sizes ranging from 23 to 268, met the

inclusion criteria for the systematic review. Designs included retrospective case

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review, prospective observational and one controlled trial without randomization.

Interventions included dynamic and static splinting with a mean follow-up ranging

from 9 weeks to 2 years. Pooling of results was not possible due to the

heterogeneity of interventions (splint type, duration and wearing regimen) and the

way outcomes were reported. The authors concluded that there is empirical

evidence to support the use of low-load prolonged stretch through splinting after

hand surgery and trauma, however only a few studies have investigated this

specifically in Dupuytren's contracture. The low level evidence regarding the effect

of post-operative static and dynamic splints on final extension deficit in severe PIP

joint contracture (greater than 40 degrees) is equivocal, as is the effect of patient

adherence on outcome. While total active extension deficit improved in some

patients wearing a splint, there were also deficits in composite finger flexion and

hand function. The lack of data on the magnitude of this effect makes it difficult to

interpret whether this is of clinical significance. There is a need for well-designed

controlled trials with proper randomization to evaluate the short-term and long-term

effectiveness of splinting following Dupuytren's surgery.

Foot drop usually refers to weakness or contracture of the muscles around the

ankle joint. It may arise from many neuromuscular diseases. In a Cochrane

review, Sackley and colleagues (2009) performed a systematic review of

randomized trials for the treatment of foot drop resulting from neuromuscular

disease. Randomized and quasi-randomized trials of physical, orthotic and surgical

treatments for foot drop resulting from lower motor neuron or muscle disease and

related contractures were included. People with primary joint disease were

excluded. Interventions included a "wait and see" approach, physiotherapy,

orthoses, surgery and pharmacological therapy. The primary outcome measure

was quantified ability to walk while secondary outcome measures included range

of motion (ROM), dorsiflexor torque and strength, measures of activity and

participation, quality of life and adverse effects. Methodological quality was

evaluated by 2 authors using the van Tulder criteria. Four studies with a total of

152 participants were included in the review. Heterogeneity of the studies

precluded pooling the data. Early surgery did not significantly affect walking speed

in a trial including 20 children with Duchenne muscular dystrophy. Both groups

deteriorated during the 12 months follow-up. After 1 year, the mean difference

(MD) of the 28-feet walking time was 0.00 seconds (95 % confidence interval [CI]:

-0.83 to 0.83) and the MD of the 150-feet walking time was -2.88 seconds, favoring

the control group (95 % CI: -8.18 to 2.42). Night splinting of the ankle did not

significantly affect muscle force or ROM about the ankle in a trial of 26 participants

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with Charcot-Marie-Tooth disease. Improvements were observed in both the

splinting and control groups. In a trial of 26 participants with Charcot-Marie-Tooth

disease and 28 participants with myotonic dystrophy, 24 weeks of strength training

significantly improved 6-meter timed walk in the Charcot-Marie-Tooth group

compared to the control group (MD 0.70 seconds, favoring strength training, 95 %

CI: 0.23 to 1.17), but not in the myotonic dystrophy group (MD -0.20 seconds,

favoring the control group, 95 % CI: -0.79 to 0.39). No significant differences were

observed for the 50-meter timed walk in the Charcot-Marie-Tooth disease group

(MD 1.90 seconds, favoring the training group, 95 % CI: -0.29 to 4.09) or the

myotonic dystrophy group (MD -0.80 seconds, favoring the control group, 95 % CI:

-5.29 to 3.69). In a trial of 65 participants with facio-scapulo-humeral muscular

dystrophy, 26 weeks of strength training did not significantly affect ankle strength.

After 1 year, the mean difference in maximum voluntary isometric contraction was

-0.43 kg, favoring the control group (95 %CI: -2.49 to 1.63) and the mean difference

in dynamic strength was 0.44 kg, favoring the training group (95 % CI: -0.89 to

1.77). The authors concluded that only 1 study, involving people with Charcot- Marie-

Tooth disease, demonstrated a statistically significant positive effect of strength

training. No effect of strength training was found in people with either myotonic

dystrophy or facio-scapulo-humeral muscular dystrophy. Surgery had no significant

effect in children with Duchenne muscular dystrophy and night splinting of the ankle

had no significant effect in people with Charcot-Marie-Tooth disease.

They stated that more evidence generated by methodologically sound studies is

needed.

In another Cochrane review, Rose et al (2010) evaluated the effect of interventions

to reduce or resolve ankle equinus in people with neuromuscular disease.

Randomized controlled trials evaluating interventions for increasing ankle

dorsiflexion ROM in neuromuscular disease. Outcomes included ankle dorsiflexion

ROM, functional improvement, foot alignment, foot and ankle muscle strength, health-

related quality of life, satisfaction with the intervention and adverse events. Two

authors independently selected papers, assessed trial quality and extracted data.

Four studies involving 149 participants met inclusion criteria for this review. Two

studies assessed the effect of night splinting in a total of 26 children and adults with

Charcot-Marie-Tooth disease type 1A. There were no statistically or clinically

significant differences between wearing a night splint and not wearing a night

splint. One study assessed the efficacy of prednisone treatment in 103 boys with

Duchenne muscular dystrophy. While a daily dose of prednisone at 0.75 mg/kg/day

resulted in significant improvements in some strength and function parameters

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compared with placebo, there was no significant difference in ankle ROM between

groups. Increasing the prednisone dose to 1.5 mg/kg/day had no significant effect

on ankle ROM. One study evaluated early surgery in 20 young boys with

Duchenne muscular dystrophy. Surgery resulted in increased ankle dorsiflexion

range at 12 months but functional outcomes favored the control group. By 24

months, many boys in the surgical group experienced a relapse of achilles tendon

contractures. The authors concluded that there is no evidence of significant benefit

from any intervention for increasing ankle ROM in Charcot-Marie-Tooth disease

type 1A or Duchenne muscular dystrophy. They stated that more research is

needed.

In a pilot study, Postans and colleagues (2010) investigated the feasibility of

applying the combination of dynamic splinting and neuromuscular electrical

stimulation (NMES) in order to improve wrist and elbow function, and ROM, in

children with upper limb contractures due to CP. A total of 6 children aged 7 to 16,

with contractures at the wrist or elbow, were recruited. Following a 12-week

baseline period all subjects underwent a 12-week treatment period where dynamic

splinting was used for 1 hour per day and combined with NMES for the second half

of the 1-hr treatment. A 12-week follow-up period then ensued. Upper limb

function was assessed with the Melbourne assessment, physical disability with the

Pediatric Evaluation of Disability Index and the Activity Scale for Kids, and quality of

life with the Pediatric Quality of Life Scale. Passive and active ROM at the wrist

and elbow were measured using manual and electrical goniometers. The

technique of using combined NMES and dynamic splinting was demonstrated to be

feasible and compliance with the intervention was good. There was an increase in

passive elbow extension in 2 subjects treated for elbow contractures, although no

accompanying change in upper limb function was reported. Wrist ROM improved

in 1 subject treated for wrist contracture. The findings of this pilot study need to be

validated by well-designed studies.

John et al (2011) stated that hallux limitus (HL) is a pathology of degenerative

arthritis in the first metatarsophalangeal joint (MTJ) of the great toe. Chief

complaints of HL include inflammation, edema, pain, and reduced flexibility. The

onset of HL commonly occurs after one of the two most common surgical

procedures for foot pathologies, a bunionectomy or a cheilectomy. These

investigators determined the effectiveness of dynamic splinting in treating patients

with post-operative hallux limitus, in a randomized, controlled trial. A total of 50

patients (aged 29 to 69 years) were enrolled after diagnosis of HL following

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surgery. The duration of this study was 8 weeks, and all patients received non-

steroidal anti-inflammatory drugs, orthotics, and instructions for a home exercise

program. Experimental patients were also treated with dynamic splinting for first

MTJ extension (60 mins, 3 times per day). The dependent variable was change in

active ROM (AROM). A repeated measures analysis of variance was used with

independent variables of patient categories, surgical procedure (cheilectomy versus

bunionectomy) and duration since surgery. There was a significant difference in

change of AROM for experimental versus control patients (p < 0.001, T = 4.224, n =

48); there was also a significant difference for patient treated within 2 months of

surgery (p = 0.0221). The authors concluded that dynamic splinting was effective

in reducing contracture of post-operative hallux limitus in this study; experimental

patients gained a mean 250 % improvement in AROM. This modality should be

considered for standard of care in treating post-operative hallux limitus.

Sameem et al (2011) stated that controversy exists as to which rehabilitation

protocol provides the best outcomes for patients after surgical repair of the extensor

tendons of the hand. These researchers determined which rehabilitation protocol

yields the best outcomes with respect to ROM and grip strength in extensor zones V-

VIII of the hand. A comprehensive literature review and assessment was undertaken

by 2 independent reviewers. Methodological quality of randomized controlled trials

(RCTs) and cohort studies was assessed using the Scottish Intercollegiate Guidelines

Network scale. A total of 17 articles were included in the final analysis (κ = 0.9). From

this total, 7 evaluated static splinting, 12 evaluated dynamic splinting, and 4 evaluated

early active splinting. Static splinting yielded "excellent/good" results ranging from 63

% (minimum) to 100 % (maximum) on the total active motion (TAM) classification

scheme and TAM ranging from 185° (minimum) to 258° (maximum) across zones V-

VIII. Dynamic splinting studies demonstrated a percentage of "excellent/good" results

ranging from 81 % (minimum) and 100 % (maximum) and TAM ranging from 214°

(minimum) and 261° (maximum). Early active splinting studies showed

"excellent/good" results ranging from 81 % (minimum) and 100 % (maximum). Only

1 study evaluated TAM in zones V-VIII, which ranged from 160° (minimum) and 165°

(maximum) when using 2 different early active modalities. The authors concluded that

the available level 3 evidence suggested better outcomes when using dynamic

splinting over static splinting. Moreover, they stated that additional studies comparing

dynamic and early active motion protocols are needed before a conclusive

recommendation can be made.

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Trismus refers to the spastic contraction of the muscles of mastication, which can

lead to mandibular hypomobility. Mandibular hypomobility is a condition in which

the patient lacks normal ROM in the temporomandibular joint (TMJ). Patients

suffering from this condition are unable to separate the maxilla and mandible

without pain, or simply are unable to open the mouth to the extent of functional

disability. They are unable to chew or eat normally or without pain, and may be

unable to speak normally or maintain proper oral hygiene. Severe jaw hypomobility

can lead to malnutrition, infection, and serious disability.

The Dynasplint Trismus System is designed to aid in restoring physical function in

patients suffering from joint or muscle stiffness and limited range ROM in the

posterior mandibular or TMJ region. These functional limitations can be caused by

a variety of conditions, such as: TMJ dysfunction, head and neck cancers, head

and neck surgery, radiation therapy, fractures, trauma, infection, burns,

congenital/developmental conditions, osteoarthritis, scleroderma, and others.

Stubblefield et al (2010) conducted a retrospective cohort study examining the

effectiveness of a dynamic jaw opening device (Dynasplint Trismus System [DTS])

as part of a multi-modal treatment strategy for trismus in 20 patients with head and

neck cancer. All patients underwent assessment by a board-certified physiatrist

and were referred to physical therapy for delivery of the DTS and instructed to

progress use of the DTS to 30 minutes 3 times a day. Additional modalities for the

treatment of trismus including pain medications and botulinum toxin injections were

prescribed as clinically indicated. Change in maximal interincisal distance (MID) as

documented in the medical record. The use of the DTS as part of multi-modal

therapy including physical therapy, pain medications, and botulinum toxin injections

as deemed clinically appropriate resulted in an overall improvement of the MID from

16.5 mm to 23.5 mm (p < 0.001). Patients who could comply with the treatment

recommendations for DTS treatment did better than those who could not, with an

improvement of the MID from 16 mm to 27 mm (p < 0.001) versus 17 mm to 22 mm

(p = 0.88).

In a retrospective clinical trial, Schulman and colleagues (2008) evaluated the effect

of the DTS (Dynasplint Systems Inc, Severna Park, MD) for patients recently

diagnosed with trismus following radiation therapy, dental treatment, oral surgery,

or following a neural pathology such as a stroke. The histories of 48 patient

(treated in 2006 to 2007) were reviewed, and divided into 4 cohort groups (radiation

therapy for head/neck cancer, dental treatment, oral surgery, or stroke), to measure

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the efficacy of this treatment's modality. Patients were prescribed the DTS after

diagnosis of trismus based on examination that showed less than 40 mm MID. The

DTS uses low-load, prolonged-duration stretch with replicable, dynamic tension to

achieve longer time at end ROM. Each patient used this device for 20 to 30 mins, 3

times per day. In this cohort case series the results showed that there was a

statistically significant difference within all patient groups (p < 0.0001; t = 10.3289),

but there was not a significant difference between groups (p = 0.374). The

biomechanical modality of DTS with a low-load, prolonged-duration stretch was

attributed to the success in reducing contracture in this study. This improved ROM

allowed patients to regain the eating, hygiene and speaking patterns they had

before developing trismus.

Guidelines from the International Society for Oral Oncology (2011) state that "[n]o

guideline [is] possible regarding use of Dynasplint® Trismus System in the reduction

of RT-induced trismus, although may have some benefit for reduction of contracture

of the muscles of mastication (Level of evidence III, Recommendation grade B)."

Furia et al (2013) evaluated the safety and effectiveness of dynamic splinting as it

is used to treat joint contracture in lower extremities, and determined if duration on

total hours of stretching had an effect on outcomes. Reviews of PubMed, Science

Direct, Medline, AMED, and EMBASE websites were conducted to identify the term

'contracture reduction' in manuscripts published from January 2002 to January

2012. Publications selected for inclusion were controlled trials, cohort studies, or

case series studies employing prolonged, passive stretching for lower extremity

contracture reduction. A total of 354 abstracts were screened and 8 studies (487

subjects) met the inclusion criteria. The primary outcome measure was change in

active ROM (AROM). The mean aggregate change in AROM was 23.5º in the 8

studies examined. Dynamic splinting with prolonged, passive stretching as home

therapy treatment showed a significant direct, linear correlation between the total

number of hours in stretching and restored AROM. No adverse events were

reported. The authors concluded that dynamic splinting is a safe and effective

treatment for lower extremity joint contractures. Joint specific stretching protocols

accomplished greater durations of end-range stretching that may be considered to

be responsible for connective tissue elongation.

Veltman et al (2015) performed a comprehensive review of the literature to evaluate

the best current evidence for non-operative treatment options for post-traumatic

elbow stiffness. These investigators performed a search of all studies on non-

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operative treatment for elbow stiffness in human adults. All articles describing non-

operative treatment of elbow stiffness, written in the English, German, French or

Dutch language, including human adult patients and with the functional outcome

reported were included in this study. A total of 8 studies (including 232 patients)

met the eligibility criteria and were included for data analysis and pooling. These

studies included 1 RCT and 7 retrospective cohort studies. Static progressive

splinting was evaluated in 160 patients. The average pre-splinting ROM of all

elbows was 72°, which improved by 36° after splinting to an average post-splinting

arc of motion of 108°. Dynamic splinting was evaluated in 72 patients with an

average pre-splinting ROM of 63°. The average improvement was 37° to an average

post-splinting arc of motion of 100°. The authors concluded that both dynamic

orthoses and static progressive splinting showed good results for the treatment of

elbow stiffness, regardless of etiology. The choice for one treatment over the other

is based on the preference of the surgeon and patient. These investigators

recommended continuing non-operative treatment with dynamic or static bracing for

12 months or until patients stop making progression in ROM of the elbow.

Dynamic Splinting to Improve Outcomes following Botulinum Toxin Injection for Treatment of Limb Spasticity

Mills and colleagues (2016) examined the quality of evidence from RCTs on the

effectiveness of adjunct therapies following botulinum toxin (BTX) injections for limb

spasticity. MEDLINE, EMBASE, CINAHL, and Cochrane Central Register of

Controlled Trials electronic databases were searched for English language human

studies from 1980 to May 21, 2015. Randomized controlled trials evaluating

adjunct therapies post-BTX injection for treatment of spasticity were included. Of

the 268 studies screened, 17 met selection criteria. Two reviewers independently

assessed risk of bias using the Physiotherapy Evidence Database (PEDro) scale

and graded according to Sackett's levels of evidence. A total of 10 adjunct

therapies were identified. Evidence suggested that adjunctive use of ES, modified

constraint-induced movement therapy, physiotherapy (all Level 1), casting and

dynamic splinting (both Level 2) result in improved Modified Ashworth Scale scores

by at least 1 grade. There is Level 1 and 2 evidence that adjunctive taping,

segmental muscle vibration, cyclic functional ES, and motorized arm ergometer

may not improve outcomes compared with BTX injections alone. There is Level 1

evidence that casting is better than taping, taping is better than ES and stretching,

and extra-corporeal shock wave therapy is better than ES for outcomes including

the Modified Ashworth Scale, ROM and gait. All results are based on single

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studies. The authors concluded that there is high level evidence to suggest that

adjunctive therapies may improve outcomes following BTX injection. Moreover,

they stated that no results have been confirmed by independent replication; all

interventions would benefit from further study.

Flexionators and Extensionators

The shoulder flexionator (ERMI Shoulder Flexionater) is designed to isolate and

treat decreased glenohumeral abduction and external rotation. The device is

intended to addresses the needs of patients with excessive scar tissue. This

customizable device has biomechanically and anatomically located pads to focus

treatment on the glenohumeral joint, without stressing the other shoulder joints.

Once customized, the shoulder flexionator can be used by the patient at home

without assistance to perform serial stretching exercises, alternately stretching and

relaxing the scar tissue surrounding the glenohumeral joint. The device has 3

sections, the main frame, arm unit and pump unit. The shoulder flexionator was

listed with the FDA in 2001, and is Class I exempt.

The knee/ankle flexionator (ERMI Knee/Ankle Flexionater) is a self-contained

device that facilitates recovery from decreased range of motion of the knee and/or

ankle joints. The knee flexionator is designed to address the needs of patients with

arthrofibrosis (excessive scar tissue within and around a joint). The knee/ankle

flexionator is a variable load/variable position device that uses a hydraulic pump

and quick-release mechanism to allow patients to perform dynamic stretching

exercises in the home without assistance, alternately stretching and relaxing the

scar tissue surrounding affected joints. The knee/ankle flexionator includes a frame

to house hydraulic components, a pump handle and quick release valve for patient

control, supporting footplate and specially incorporated padded chair. The frame

attaches to a folding chair and is adjustable to accommodate treatment of either

extremity, or both extremities simultaneously. The load potential ranges from a few

ounces up to 500 foot-pounds. The knee/ankle flexionator was listed with the FDA

in 2002, and is Class 1 exempt.

The knee extensionator (ERMI Knee Extensionater) and elbow extensionator

(ERMI Shoulder Extensionater) provide serial stretching, using a patient-controlled

pneumatic device that can deliver variable loads to the affected joint. The

manufacturer claims that the knee and shoulder extensionators are the only

devices on the market that can “consistently stretch scar tissue, without causing

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Page 14 of 27

vascular re-injury and thereby significantly reduce the need for additional

surgery” (ERMI, 2002). The extensionator telescopes to the appropriate length,

and is applied to the leg with Velcro straps. During a typical training session, the

joint is stretched from 1 to 5 mins, and then is allowed to recover for an equal

length of time, and is then stretched again. A typical training session lasts 15 mins,

and the usual prescription is to perform 4 to 8 training sessions per day. There are

no controlled published peer-reviewed studies on the effectiveness of the

knee/ankle flexionator, the shoulder flexionator, the knee extensionator, or the

elbow extensionator. There is insufficient scientific evidence to support the

manufacturer's claims that these home-based stretching devices can consistently

stretch scar tissues without causing vascular re-injury and thus significantly reduce

the need for additional surgery (e.g., surgery for arthrofibrosis after knee surgery).

Furthermore, there is a lack of published data to support the claim that these

devices can reduce the need for surgery manipulation under anesthesia.

Therefore, extensionator and flexionator devices are considered experimental and

investigational.

The Elite Seat is a portable knee hyper-extension rehabilitation device that is used

to correct the loss of knee extension, increase ROM, decrease knee pain and

improve function. However, there is insufficient evidence to support the use of the

Elite Seat.

Joint Active Systems (JAS) Splints

JAS splints (e.g., JAS Elbow, JAS Shoulder, JAS Ankle, JAS Knee, JAS Wrist, and

JAS Pronation-Supination) (Joint Active Systems, Effingham, IL) use static

progressive stretch. According to the manufacturer's website, "Static Progressive

Stretch (SPS) and dynamic splinting are two fundamentally different techniques

used to permanently lengthen shortened connective tissues." Typically, the patient

sets the device angle at the beginning of the session, and every several mins the

angle is increased. A typical session lasts 30 mins, and sessions may be repeated

up to 3 times per day. Unlike the flexionator, the joint is not allowed to recover

during the stretch period. According to the manufacturer, JAS systems are

designed to simulate manual therapy. The manufacturer claims that JAS devices

eliminate the risk of joint compression, provide soft tissue distraction, and “achieve

permanent soft tissue lengthening in a short amount of time.” Published reports of

the effectiveness of JAS splints are limited to case reports and small

uncontrolled observational studies. There are no prospective randomized studies


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Page 15 of 27

demonstrating that the addition of the use of JAS devices to the physical therapy

management of patients with joint injury or surgery significantly improves patient's

clinical outcomes. Thus, JAS splints are considered experimental and

investigational.

EZ Turnbuckle Orthosis (Joint Active Systems Orthosis)

Green and McCoy (1979) reported the findings of 15 patients with acute flexion

contractures of the elbow after injuries or operations were treated with a turnbuckle

splint. Satisfactory correction was achieved in 12 patients. An average reduction in

deformity of about 37 degrees was recorded after an average treatment period of

20 weeks. The treatment was unsuccessful in 3 patients with severe intra-articular

damage because the splint caused excessive discomfort. The average

improvement in the arc of motion of the elbow was approximately 43 degrees. This

was a small study (n = 15); its findings need to be validated in well-designed

studies.

Gelinas et al (2000) treated 22 patients with an elbow contracture using a static

progressive turnbuckle splint for a mean of 4.5 +/- 1.8 months. All had failed to

improve with supervised physiotherapy and splinting. The mean range of flexion

before splintage was from 32 +/- 10 degrees to 108 +/- 19 degrees and afterwards

from 26 + 10 (p = 0.02) to 127 +/- 12 degrees (p = 0.0001). A total of 11 patients

gained a “functional arc of movement”, defined as at least 30 degrees to 130

degrees. In 8 patients movement improved with turnbuckle splinting, but the

functional arc was not achieved; 6 of these were satisfied and did not wish to

proceed with surgical treatment and 2 had release of the elbow contracture. In 3

patients, movement did not improve with the use of the turnbuckle splint and 1

subsequently had surgical treatment. The authors concluded that these findings

showed that turnbuckle splinting is a safe and effective treatment that should be

considered in patients whose established elbow contractures have failed to respond

to conventional physiotherapy. This was a small study (n = 22); its findings need to

be validated in well-designed studies.

Bhat et al (2010) evaluated the effectiveness of a turnbuckle orthosis as a means of

improving the range of motion (ROM) in patients with elbow stiffness. A total of 17

males and 11 females aged 8 to 68 (mean of 32) years underwent static

progressive stretching using a turnbuckle orthosis for elbow stiffness secondary to

trauma or surgery. Patients were instructed to wear the orthosis during the daytime

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for a mean of 15 hours and remove it during sleep as well as at breakfast, lunch,

and dinner. One hour of ROM exercise was performed during each break.

Patients were followed-up every month and ROM was recorded with a standard

goniometer. The use of orthosis was discontinued when there was no further

improvement; ROM exercise was encouraged thereafter to maintain the results.

The extent of flexion contracture and ROM before and after the treatment were

compared. The mean duration of orthosis use was 5 (range of 3 to 8) months. The

mean flexion contracture reduced from 59 degrees to 27 degrees and ROM

improved from 57 degrees to 102 degrees; 19 of the patients achieved functional

ROM. Improvement in ROM was excellent in 6 patients, good in 11, satisfactory in

7; at the end of follow-up (mean of 29 months), the results were maintained or

improved further in 20 patients (even in those with long-standing contractures).

The authors concluded that static progressive stretching using a turnbuckle orthosis

is reliable and cost-effective for treating elbow stiffness. Again, this was a small

study (n = 28); its findings need to be validated in well-designed studies.

CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

CPT codes covered if selection criteria are met:

29126 Application of short arm splint (forearm to hand); dynamic [not covered

for carpal tunnel syndrome]

29131 Application of finger splint; dynamic

Other CPT codes related to the CPB:

25515 Open treatment of radial shaft fracture, includes internal fixation, when

performed

29105 Application of long arm splint (shoulder to hand)

29505 Application of long leg splint (thigh to ankle or toes)

29515 Application of short leg splint (calf to foot)

97760 Orthotic(s) management and training (including assessment and fitting

when not otherwise reported), upper extremity(s), lower extremity(s)

and/or trunk, each 15 minutes

HCPCS codes covered if selection criteria are met:

Advance Dynamic ROM, Pro-glide dynamic ROM, SaeboReach, EZ Turnbuckle Orthosis:

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Code Code Description

No specific code

E1800 Dynamic adjustable elbow extension/flexion device, includes soft

interface material

E1802 Dynamic adjustable forearm pronation/supination device, includes soft

interface material [not covered for carpal tunnelsyndrome]

E1805 Dynamic adjustable wrist extension/flexion device, includes soft

interface material [not covered for carpal tunnel syndrome]

E1810 Dynamic adjustable knee extension/flexion device, includes soft

interface material

E1825 Dynamic adjustable finger extension/flexion device, includes soft

interface material

E1830 Dynamic adjustable toe extension/flexion device, includes soft interface

material

E1831 Static progressive stretch toe device, extension and/or flexion, with or

without range of motion adjustment, includes all components and

accessories

HCPCS codes not covered for indications listed in the CPB:

ERMI Knee/Ankle Flexionator, MPJ Extensionator, ERMI Elbow Extensionator , ERMI Shoulder Flexionator, ERMI Knee Extensionator, SaeboMas, JAZ EZ:

No specific code

E1801 Static progressive stretch elbow device, extension and/or flexion, woth

or without range of motion adjustment, includes all components and

accessories

E1806 Static progressive stretch wrist device, flexion and/or extension, with or


accessories

E1811 Static progressive stretch knee device, extension and/or flexion, with or


accessories

E1815 Dynamic adjustable ankle extension/flexion device, includes soft

interface material

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Page 18 of 27

Code Code Description

E1816 Static progressive stretch ankle device, flexion and/or extension, with or


accessories

E1818 Static progressive stretch forearm pronation/supination device, with or


accessories

E1821 Replacement soft interface material/cuffs for bi-directional static

progressive stretch device

E1840 Dynamic adjustable shoulder flexion/abduction/rotation device, includes

soft interface material

E1841 Static progressive stretch shoulder device, with or without range of

motion adjustment, includes all components and accessories

Other HCPCS codes related to the CPB:

J0585 Injection, onabotulinumtoxinA, 1 unit

J0586 Injection, abobotulinumtoxinA, 5 units

J0587 Injection, rimabotulinumtoxinB, 100 units

J0588 Injection, incobotulinumtoxinA, 1 unit ICD

10 codes not covered for indications listed in the CPB: G35

Multiple sclerosis

G56.00 - G56.03 Carpal tunnel syndrome

G71.00 - G72.9,

G73.7

Primary disorders of muscles and other and unspecified myopathies

G80.0 - G80.9 Cerebral palsy

G97.31 - G97.32 Intraoperative hemorrhage and hematoma of a nervous system organ or

structure complicating a procedure

I63.00 - I66.9 Occlusion and stenosis of precerebral and cerebral arteries [stroke]

I97.810 -

I97.821

Intraoperative and postprocedural cerebrovascular infarction

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Page 19 of 27

06/28/2019

M21.379

M72.2

R25.2

S06.0x0+ -

S06.9x9+

S09.90x+




Page 20 of 27

The above policy is based on the following references:

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Rehabilitation Medicine: Principles and Practice. 2nd ed. JA DeLisa, ed.

Philadelphia, PA: J.B. Lippincott Co.; 1993; Ch. 33: 681-699.

2. McClure PW, Blackburn LG, Dusold C. The use of splints in the treatment

of joint stiffness: Biologic rationale and an algorithm for making clinical

decisions. Phys Ther. 1994;74(12):1101-1107.

3. Hepburn GR, Crivelli KJ. Use of elbow Dynasplint for reduction of elbow

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(5):269-274.

4. Richard RL. Use of the Dynasplint to correct elbow flexion burn

contracture: A case report. J Burn Care Rehabil. 1986;7(2):151-152.

5. Mackay-Lyons M. Low-load, prolonged stretch in treatment of elbow

flexion contractures secondary to head trauma: A case report. Phys Ther.

1989;69(4):292-296.

6. Richard RL, Jones LM, Miller SF, Finley RK Jr. Treatment of exposed bilateral

Achilles tendons with use of the Dynasplint. Phys Ther. 1988;68(6):989

991.

7. Hepburn GR. Case studies: Contracture and stiff joint management with

Dynasplint. J Orthop Sports Phys Ther. 1987;8:498-504.

8. Steffen TM, Mollinger LA. Low-load, prolonged stretch in the treatment of

knee flexion contractures in nursing home residents. Phys Ther. 1995;75

(10):886-897.

9. Chow JA, Thomes LJ, Dovelle S, et al. Controlled motion rehabilitation after

flexor tendon repair and grafting. J Bone Joint Surg. 1988;70(4):591-595.

10. Chow JA, Dovelle S, Thomes LJ, et al. A comparison of results of extensor

tendon repair followed by early controlled mobilization versus static

immobilization. J Hand Surg. 1989;14(1):18-20.

11. Browne EZ Jr, Ribik CA. Early dynamic splinting for extensor tendon

injuries. J Hand Surg [Am]. 1989;14(1):72-76.

12. Kerr CD, Burczak JR. Dynamic traction after extensor tendon repair in zone

6, 7, and 8: A retrospective study. J Hand Surg [Br]. 1989;14(1):21-25.

13. Saldana MJ, Chow JA, Gerbino P 2nd, et al. Further experience in

rehabilitation of zone II flexor tendon repair with dynamic traction

splinting. Plast Reconstr Surg. 1991;87(3):543-546.

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Page 21 of 27

14. Hung LK, Chan A, Chang J, et al. Early controlled active mobilization with

dynamic splintage for treatment of extensor tendon injuries. J Hand Surg

[Am]. 1990;15 (2):251-257.

15. Saldana MJ, Choban S, Westerbeck P, Schacherer TG. Results of acute zone

III extensor tendon injuries treated with dynamic extension splinting. J

Hand Surg [Am]. 1991;16 (6):1145-1150.

16. Rives K, Gelberman R, Smith B, Carney K. Severe contractures of the

proximal interphalangeal joint in Dupuytren's disease: Results of a

prospective trial of operative correction and dynamic extension splinting. J

Hand Surg [Am]. 1992;17 (6):1153-1159.

17. May EJ, Silfverskiold KL, Sollerman CJ. The correlation between controlled

range of motion with dynamic traction and results after flexor tendon

repair in zone II. J Hand Surg [Am]. 1992;17 (6):1133-1139.

18. Blair WF, Steyers CM. Extensor tendon injuries. Orthop Clin North Am.

1992;23(1):141-148.

19. Center for Medicare and Medicaid Services (CMS). Payment and coding

determinations for new durable medical equipment. CMS Public Meeting

Agenda. Baltimore, MD: CMS; June 17, 2002. Available

at: http://www.hcfa.gov/medicare/jun2dme.pdf. Accessed July 25, 2002.

20. ERMI, Inc. Insurance Provider Information Folder. Decatur, GA: ERMI; 2002.

21. Bonutti PM, Windau JE, Ables BA, et al. Static progressive stretch to

reestablish elbow range of motion. Clin Orthop. 1994;303:128-134.

22. Steffan TM, Mollinger LA. Low-load, prolonged stretch in the treatment of

knee flexion contractures in nursing home residents. Phys Ther.

1995;75:886-897.

23. Jansen CM, Windau JE, Bonutti PM, et al. Treatment of a knee contracture

using a knee orthosis incorporating stress-relaxation techniques. Phys

Ther. 1996;76(2):182-186.

24. Cohen EJ. Adjunctive therapy devices: Restoring ROM outside of the clinic.

Phys Ther Magazine. 1995 Mar:10-13.

25. Crosby CA, Wehbe MA. Early protected motion after extensor tendon

repair. J Hand Surg [Am]. 1999;24(5):1061-1070.

26. Joint Active Systems, Inc. JAS OnLine [website]. Effingham, IL: Joint Active

Systems; 2002. Available at: http://www.jointactivesystems.com. Accessed

September 11, 2002.

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Page 22 of 27

27. Khandwala AR, Webb J, Harris B, et al. A comparison of dynamic extension

splinting and controlled active mobilization of complete divisions of

extensor tendons in zones 5 and 6. J Hand Surg [Br]. 2000;25(2):140-146.

28. Hewitt B, Shakespeare D. Flexion vs. extension: A comparison of post

operative total knee arthroplasty mobilisation regimes. Knee. 2001;8

(4):305-309.

29. Harvey L, Herbert R, Crosbie J. Does stretching induce lasting increases in

joint ROM? A systematic review. Physiother Res Int. 2002;7(1):1-13.

30. Branch TP, Karsch RE, Mills TJ, Palmer MT. Mechanical therapy for loss of

knee flexion. Am J Orthop. 2003;32(4):195-200.

31. Washington State Department of Labor and Industries, Office of the

Medical Director. ERMI Flexionators and Extensionators. Health

Technology Assessment Brief. Olympia, WA: Washington State

Department of Labor and Industries; updated June 6, 2003. Available

at: www.lni.wa.gov/ClaimsInsurance/Files/OMD/ermi.pdf. Accessed June 3,

2004.

32. Michlovitz SL, Harris BA, Watkins MP. Therapy interventions for improving

joint range of motion: A systematic review. J Hand Ther. 2004;17(2):118

131.

33. Thien TB, Becker JH, Theis J-C. Rehabilitation after surgery for flexor

tendon injuries in the hand. Cochrane Database Syst Rev. 2004;

(4):CD003979.

34. Joint Active Systems, Inc. Principles of static progressive stretch. JAS

Professionals. Joint Active Systems: The Static Progressive Stretch

Company [website]. Effingham, IL: Joint Active Systems; 2008. Available at:

http://www.jointactivesystems.com/pf_principles.html. Accessed May 29,

2008.

35. Germann G, Wagner H, Blome-Eberwein S, Karle B, Wittemann. Early

dynamic motion versus postoperative immobilization in patients with

extensor indicis proprius transfer to restore thumb extension: A

prospective study. J Hand Surg. 2001;26A:1111-1115.

36. Chester DL, Beale S, Beveridge L, et al. A prospective, controlled,

randomized trial comparing early active extension with passive extension

using a dynamic splint in the rehabilitation of repaired extensor tendons. J

Hand Surg (Br). 2002; 27N(3):283-288.

37. Bruner A, Whittemann A, Jester A, et al. Dynamic splinting after extensor

tendon repair in zones V to VII. J Hand Surg (Br). 2003;28B(3):224-227.

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http://www.jointactivesystems.com/pf_principles.html


Page 23 of 27

38. Greer MA, Miklos-Essenberg ME. Early mobilization using dynamic

splinting with acute triceps tendon avulsion. J Hand Ther. 2005;18:365-371.

39. Mowlavi A, Burns M, Brown RE. Dynamic versus static splinting for simple

zone V and zone VI extensor tendon repairs: A prospective, randomized,

controlled study. Plast Recontr Surg. 2005;115:482-487.

40. Ring D, Hotchkiss RN, Guss D, Jupiter JB. Hinged elbow external fixation for

severe elbow contracture. J Bone Joint Surg Am. 2005;87(6):1293-1296.

41. Farmer SE, Woollam PJ, Patrick JH, et al. Dynamic orthoses in the

management of joint contracture. J Bone Joint Surg Br. 2005;87(3):291-295.

42. Doornberg JN, Ring D, Jupiter JB. Static progressive splinting for

posttraumatic elbow stiffness. J Orthop Trauma. 2006;20(6):400-404.

43. Tan O, Atik B, Dogan A, et al. Postoperative dynamic extension splinting

compared with fixation with Kirschner wires and static splinting in

contractures of burned hands: A comparative study of 57 cases in 9 years.

Scand J Plast Reconstr Surg Hand Surg. 2007;41(4):197-202.

44. Verdugo RJ, Salinas RS, Castillo J, Cea JG. Surgical versus non-surgical

treatment for carpal tunnel syndrome. Cochrane Database Syst Rev. 2003;

(3):CD001552.

45. Goodyear-Smith F, Arroll B. What can family physicians offer patients with

carpal tunnel syndrome other than surgery? A systematic review of

nonsurgical management. Ann Fam Med. 2004;2(3):267-273.

46. Graham RG, Hudson DA, Solomons M, Singer M. A prospective study to

assess the outcome of steroid injections and wrist splinting for the

treatment of carpal tunnel syndrome. Plast Reconstr Surg. 2004;113

(2):550-556.

47. Larson D, Jerosch-Herold C. Clinical effectiveness of post-operative

splinting after surgical release of Dupuytren's contracture: A systematic

review. BMC Musculoskelet Disord. 2008;9:104.

48. Sackley C, Disler PB, Turner-Stokes L, et al. Rehabilitation interventions for

foot drop in neuromuscular disease. Cochrane Database Syst Rev. 2009;

(3):CD003908.

49. Evans PJ, Nandi S, Maschke S, et al. Prevention and treatment of elbow

stiffness. J Hand Surg Am. 2009;34(4):769-778.

50. Lucado AM, Li Z. Static progressive splinting to improve wrist stiffness

after distal radius fracture: A prospective, case series study. Physiother

Theory Pract. 2009;25:297-309.

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Page 24 of 27

51. Bonutti PM, McGrath MS, Ulrich SD, et al. Static progressive stretch for the

treatment of knee stiffness. Knee. 2008;15(4):272-276.

52. McGrath MS, Ulrich SD, Bonutti PM, et al. Evaluation of static progressive

stretch for the treatment of wrist stiffness. J Hand Surg Am. 2008;33

(9):1498-1504.

53. McGrath MS, Bonutti PM, Marker DR, et al. Static progressive splinting for

restoration of rotational motion of the forearm. J Hand Ther. 2009;22 (1):3

9.

54. Sharma NK, Loudon JK. Static progressive stretch brace as a treatment of

pain and functional limitations associated with plantar fasciitis: a pilot

study. Foot Ankle Spec. 2010;3:117-124.

55. Bonutti PM, Marulanda GA, McGrath MS, et al. Static progressive stretch

improves range of motion in arthrofibrosis following total knee

arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2010;18(2):194-199.

56. Ulrich SD, Bonutti PM, Seyler TM, et al. Restoring range of motion via

stress relaxation and static progressive stretch in posttraumatic elbow

contractures. J Shoulder Elbow Surg. 2010;19(2):196-201.

57. Rose KJ, Burns J, Wheeler DM, North KN. Interventions for increasing ankle

range of motion in patients with neuromuscular disease. Cochrane

Database Syst Rev. 2010;(2):CD006973.

58. Berner SH, Willis FB. Dynamic splinting in wrist extension following distal

radius fractures. J Orthop Surg Res. 2010;5:53.

59. Sheridan L, Lopez A, Perez A, et al. Plantar fasciopathy treated with

dynamic splinting: A randomized controlled trial. J Am Podiatr Med Assoc.

2010;100(3):161-165.

60. Postans N, Wright P, Bromwich W, et al. The combined effect of dynamic

splinting and neuromuscular electrical stimulation in reducing wrist and

elbow contractures in six children with cerebral palsy. Prosthet Orthot Int.

2010;34(1):10-19.

61. John MM, Kalish S, Perns SV, Willis FB. Dynamic splinting for postoperative

hallux limitus: A randomized, controlled trial. J Am Podiatr Med Assoc.

2011;101(4):285-288.

62. Sameem M, Wood T, Ignacy T, et al. A systematic review of rehabilitation

protocols after surgical repair of the extensor tendons in zones V-VIII of

the hand. J Hand Ther. 2011;24(4):365-372.

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Page 25 of 27

63. Neuhaus V, Wong G, Russo KE, Mudgal CS. Dynamic splinting with early

motion following zone IV/V and TI to TIII extensor tendon repairs. J Hand

Surg Am. 2012;37(5):933-937.

64. Shulman DH et al. Treating trismus with dynamic splinting: a cohort, case

series. Adv Ther. 2008;25(1): 9-16.

65. Stubblefield MD et al. A preliminary report on the efficacy of a dynamic

jaw opening device (dynasplint trismus system) as part of the multimodal

treatment of trismus in patients with head and neck cancer. Arch Phys

Med Rehabil. 2010;91(8): 1278-1282.

66. Kitis A, Ozcan RH, Bagdatli D, et al. Comparison of static and dynamic

splinting regimens for extensor tendon repairs in zones V to VII. J Plast

Surg Hand Surg. 2012;46(3-4):267-271.

67. Lindenhovius AL, Doornberg JN, Brouwer KM, et al. A prospective

randomized controlled trial of dynamic versus static progressive elbow

splinting for posttraumatic elbow stiffness. J Bone Joint Surg Am. 2012;94

(8):694-700.

68. Stephenson JJ, Quimbo RA, Gu T. Knee-attributable medical costs and risk

of re-surgery among patients utilizing non-surgical treatment options for

knee arthrofibrosis in a managed care population. Curr Med Res Opin.

2010;26(5):1109-1118.

69. Uhl TL, Jacobs CA. Torque measures of common therapies for the

treatment of flexion contractures. J Arthroplasty. 2011;26(2):328-334.

70. Dempsey AL, Mills T, Karsch RM, Branch TP. Maximizing total end range

time is safe and effective for the conservative treatment of frozen

shoulder patients. Am J Phys Med Rehabil. 2011;90(9):738-745.

71. Papotto BA, Mills T. Treatment of severe flexion deficits following total

knee arthroplasty: A randomized clinical trial. Orthop Nurs. 2012;31(1):29

34.

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Based Management Strategies for Oral Complication from Cancer

Treatment. Hillerød, Denmark: MASCC; 2011.

73. Furia JP, Willis FB, Shanmugam R, Curran SA. Systematic review of

contracture reduction in the lower extremity with dynamic splinting. Adv

Ther. 2013;30(8):763-770.

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Page 26 of 27

74. Veltman ES, Doornberg JN, Eygendaal D, et al. Static progressive versus

dynamic splinting for posttraumatic elbow stiffness: A systematic review of

232 patients. Arch Orthop Trauma Surg. 2015;135(5):613-617.

75. Green DP, McCoy H. Turnbuckle orthotic correction of elbow-flexion

contractures after acute injuries. J Bone Joint Surg Am. 1979;61(7):1092

1095.

76. Gelinas JJ, Faber KJ, Patterson SD, King GJ. The effectiveness of turnbuckle

splinting for elbow contractures. J Bone Joint Surg Br. 2000;82(1):74-78.

77. Bhat AK, Bhaskaranand K, Nair SG. Static progressive stretching using a

turnbuckle orthosis for elbow stiffness: A prospective study. J Orthop Surg

(Hong Kong). 2010;18(1):76-79.

78. Mills PB, Finlayson H, Sudol M, O'Connor R. Systematic review of adjunct

therapies to improve outcomes following botulinum toxin injection for

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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan

benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,

general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care

services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in

private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible

for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to

change.

Copyright © 2001-2019 Aetna Inc.

http://www.aetna.com/cpb/medical/data/400_499/0405.html 06/28/2019


AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number: 0405 Mechanical

Stretching Devices for Contracture and Joint Stiffness

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania updated 03/12/2019

http://www.aetnabetterhealth.com/pennsylvania

Documents

Prior Authorization Review Panel MCO Policy Submission A ... · Aetna considers dynamic splinting devices for the knee, elbow, wrist, finger, or toe medically necessary durable medical