MEDICAL POLICY

POLICY
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POLICY GUIDELINES
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

Stretching Devices for Joint Stiffness and Contracture

Number 1.01.514

Effective Date February 24, 2014

Revision Date(s) 02/10/14; 02/11/13; 03/13/12; 02/08/11; 01/12/10; 01/13/09; 01/08/08; 01/09/07; 01/10/06, 01/11/05

Replaces N/A

Policy

Mechanical (dynamic) stretching devices for joint stiffness or contracture may be considered medically necessary durable medical equipment (DME) when the criteria are met for ONE of the following:

  • As an adjunct to physical therapy for 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 but less than 4 months after injury or surgery); or
  • In the acute post-operative period for members who have a documented prior history of motion stiffness/loss in a joint and are having additional surgery or procedures done to improve motion of the affected joint

Mechanical (dynamic) stretching devices may be considered medically necessary only when part of a structured physical therapy program following a recent injury or surgery.

Mechanical (dynamic) stretching devices is considered not medically necessary if there is no measurable improvement after four months of use.

Mechanical (dynamic) stretching devices is considered not medically necessary in the prophylactic management of chronic contractures (that is-no significant change in motion occurred for a 4-month period) and chronic joint stiffness due to joint trauma, fractures, burns, head and spinal cord injuries, rheumatoid arthritis, multiple sclerosis, muscular dystrophy or cerebral palsy, and other chronic neuromuscular conditions.

Related Policies

None

 

Policy Guidelines

N/A

Description

Joint stiffness or contractures are commonly caused by immobilization following injury, surgery or a disease process. A joint contracture can occur at any joint in the body and is characterized by a decreased range of motion due to structural changes in muscles, tendons, ligaments and skin that occur when elastic connective tissue is replaced with inelastic fibrous material that is resistant to stretching.

Low-load Prolonged-duration Stretch (LLPS) Devices/Dynamic Splinting Systems

Dynamic splinting systems are spring-loaded, adjustable devices designed to provide low-load prolonged-duration stretch (LLPS) 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, 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 systems include: Dynasplint™, EMPI Advance™, LMB Pro-glide™, SaeboFlex™, and Ultraflex™.

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 address 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 three 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 I 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 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 minutes, and then is allowed to recover for an equal length of time, and is then stretched again. A typical training session lasts 15 minutes, and the usual prescription is to perform 4 to 8 training sessions per day.

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 bi-directional static progressive stretch. Typically, the patient sets the device angle at the beginning of the session, and every several minutes the angle is increased. A typical session lasts 30 minutes, and sessions may be repeated up to three 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.” There are no prospective randomized studies 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.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

Benefit Application

N/A

Rationale

This policy was originally created in 2005 and has been updated based on searches of the MEDLINE database. The most recent literature search was performed for the period of April 2012 through January 2014. The following is a summary of the key findings since the policy was created to date

Tan and colleagues (2007) report on postoperative dynamic extension splinting compared with fixation with Kirschner wires and static splinting in contractures of burned hands. The main disadvantage of skin grafting is a tendency to contract again. The authors compared the outcomes of dynamic and static splinting postoperatively. Fifty-seven patients were studied over a period of 9 years. Thirty six patients (44 hands) had Kirschner (K) wires applied with static splints; twenty-one patients (26 hands) had dynamic splinting. The mean age was 11 (range 2-37) and 15 (range 2-50) years in the two groups. Before and after the operation, basic hand functions were evaluated clinically, and the results analyzed statistically. The mean follow-up times were 18 and 14 months respectively, and recurrence rates were 22% and 14%. The authors concluded that postoperative dynamic splinting is superior to fixation with K-wires with or without static splints. (1)

Berner and Willis (2010) performed a retrospective review of 133 patients with wrist flexion contracture who were treated with a Wrist Extension Dynasplint (WED) following distal radius fractures. Their purpose was to evaluate the initial effect of dynamic splinting as a home therapy on wrist extension (active range of motion {AROM}), in both surgical and non-surgical patients. Their results showed a significant improvement in AROM for all patients after a mean duration of 3.9 weeks of dynamic splinting. Patients showed a mean 62% increase in active extension. There was not a significant difference between patients receiving surgery and those not receiving surgery. The authors concluded that dynamic splinting contributed 138 to 185 hours of stretching in their first month following fracture and was directly responsible for an increase of 16 degrees AROM measurement.(2)

Sameem et al (2011) reported on a systematic review stating 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’ conclusion is that the available level 3 evidence suggested better outcomes when using dynamic splinting over static splinting. The authors that before a conclusive recommendation can be made, additional studies comparing dynamic and early active motion protocols are needed.(3)

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 with the onset commonly occurring after, a bunionectomy or a cheilectomy surgery. A total of 50 patients (aged 29 to 69 years) diagnosed with post-operative HL were enrolled in a randomized controlled trial (RCT). 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 minutes, 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. The authors state that this modality should be considered for standard of care in treating post-operative hallux limitus. (4)

There are no published professional society positions found that address the use of stretching devices.

Summary

In the sub-acute injury or post-operative period, select patients may benefit from treatment with active and passive ranges of motion exercises, as well as progressive splinting/dynamic stretching devices as interventions for joint stiffness or contracture. Several FDA approved commercial devices are available that are designed as an integral component of physical therapy to improve mobilization of stiff joints or in the rehabilitation of soft tissue around joints. There is no evidence that one type of joint contracture device is superior over others. Although there is insufficient data in the peer reviewed literature to validate the effectiveness of these devices, this technology is widely used in the Orthopedic, Rehabilitation Medicine and Physical Therapy communities and has become a community standard.

References

  1. Tan O, Atki 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. Scan J Plast Reconstr Surg Hand Surg. 2007;41(4):197-202
  2. Berner SH, Willis FB. Dynamic splinting in wrist extension following distal radius fractures. Journal of Orthopaedic Surgery and Research 2010. 5:53.
  3. 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.
  4. 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.

Additional resources and websites:

  1. Richard R, Shanesy CP, Miller SF. Dynamic versus Static Splints: A Prospective Case for Sustained Stress. J Burn Care Rehabilitation, 1995; 16(3 pt 1):284-7.
  2. Cohen EJ. Adjunctive Therapy Devices: Restoring ROM Outside of the Clinic. Phys Ther Magazine, 1995; 10-13.
  3. 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.
  4. Joint Active Systems, Inc. JAS OnLine (website). Effingham, IL: Joint Active Systems, 2002; available at http://www.jointactivesystems.com. Last accessed January 4, 2013.
  5. Chester DL, Beale S, Beveridge L et al. A Prospective, Controlled, Randomized Trail Comparing Early Active Extension with Passive Extension Using a Dynamic Splint in the Rehabilitation of Repaired Extensor Tendons. J Hand Surg, 2002; 27(3):283-8.
  6. Harvy L, Herbert R, Crosbie J. Does Stretching Induce Lasting Increases in Joint ROM? A Systematic Review. Physiother Res Int, 2002; 7(1):1-13.
  7. Branch TP, Karsch RE, Mills TJ, Palmer MT. Mechanical Therapy for Loss of Knee Flexion. Am J Orthop, 2003; 32(4):195-200.
  8. Egan M, Brosseau L, Farmer M et al. Splints and Orthosis for Treating Rheumatoid Arthritis (Cochrane Review) in The Cochrane Library, Issue 3, 2003; Oxford, UK: Update Software.
  9. 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: http://www.lni.wa.gov/ClaimsIns/Files/OMD/ermi.pdf Last accessed January 4, 2013.
  10. Michlovitz, SL, Harris BA, Watkins MP. Therapy Interventions for Improving Joint Range of Motion: A Systematic Review. J Hand Ther. 2004; 17(2):118-31.
  11. Hayes Inc. Hayes Medical Technology Directory. Mechanical Stretching Devices for the Treatment of Joint Contractures of the Extremities. Lansdale, PA: Hayes, Inc.; February 2013.

Coding

Codes

Number

Description

HCPCS

E1800

Dynamic adjustable elbow extension/flexion device, includes soft interface material

 

E1801

Static progressive stretch elbow device, extension and/or flexion, with or without range of motion adjustment, includes all components and accessories

 

E1802

Dynamic adjustable forearm pronation/supination device, includes soft interface material

 

E1805

Dynamic adjustable wrist extension/flexion device, includes soft interface material

 

E1806

Static progressive stretch wrist device, flexion and/or extension, with or without range of motion adjustment, includes all components and accessories

 

E1810

Dynamic adjustable knee extension/flexion device, includes soft interface material

 

E1811

Static progressive stretch knee device, extension and/or flexion, with or without range of motion adjustment, includes all components and accessories

 

E1812

Dynamic knee, extension/flexion device with active resistance control

 

E1815

Dynamic adjustable ankle extension/flexion device, includes soft interface material

 

E1816

Static progressive stretch ankle device, flexion and/or extension, with or without range of motion adjustment, includes all components and accessories

 

E1818

Static progressive stretch forearm pronation/supination device, with or without range of motion adjustment, includes all components and accessories

 

E1820

Replacement soft interface material, dynamic adjustable extension/flexion device

 

E1821

Replacement soft interface material/cuffs for bi-directional static progressive stretch device

 

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

 

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

Appendix

N/A

History

Date

Reason

1/11/05

Add to Durable Medical Equipment - New policy

1/10/06

Replace Policy - Policy updated with literature search; policy statement unchanged. Title changed for clarification (old title: Mechanical Stretching Devices for Joint Stiffness and Contracture).

04/21/06

Codes Updated - No other changes

05/26/06

Update Scope and Disclaimer - No other changes.

01/09/07

Replace Policy - Policy updated with literature review; references added; no change in policy statement.

01/08/08

Replace Policy - Policy updated with literature review; no change in policy statement.

01/13/09

Replace Policy - Policy updated with literature review, no change in policy statement. Reference added.

01/12/10

Replace Policy - Policy updated with literature review, no change in policy statement.

02/08/11

Replace Policy - Policy updated with literature review, no change in policy statement. Reference added. New code E1831 added.

03/23/12

Replace Policy. Policy reviewed. No change in policy statement.

02/11/13

Replace policy. Policy section updated with 2 statements: Mechanical (dynamic) stretching devices may be considered not medically necessary when not part of a structured physical therapy program following a recent injury or surgery. Mechanical (dynamic) stretching devices may be considered not medically necessary if there is no significant improvement after four months of use. Rationale section revised based on a literature search through January 2013. Rationale reformatted to delete years without any literature update or addition of references. References 3-4 added; others renumbered or removed. Policy statement changed as noted.

02/24/14

Replace policy. No change to policy statement. Added Hayes reference.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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