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MP 1.01.100

Stretching Devices for the Treatment of Joint Stiffness and Contracture

 

Medical Policy    
Section
Durable Medical Equipment
Original Policy Date
09/08

Last Review Status/Date
Created local policy with literature search/9:2008

Issue
12:2008
  Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.

 


Description

Joint stiffness or contractures are commonly caused by immobilization following injury, disease, or surgery.  A joint contracture is characterized by persistently reduced range of motion as a result of structural changes in muscles, tendons, ligaments, and skin which occur when elastic connective tissue is replaced with inelastic fibrous material, resulting in tissue that is resistant to stretching.

Several types of stretching devices are available and may be classified as follows:
  • Dynamic (low-load prolonged-duration stretch [LLPS]) devices – allow resisted active and passive motion (elastic traction) within a restricted range. LLPS devices sustain a set level of tension using integrated springs. Examples of LLPS devices include: Dynasplint System®, EMPI Advance Dynamic ROM®, and LMB Pro-Glide™. 
  • Bi-directional static progressive (SP) stretch devices - maintain the joint in a set position but permit manual modification of the joint angle and may allow for active motion without resistance (inelastic traction). Examples include the Joint Active Systems (JAS) splints (e.g., JAS Elbow, JAS Shoulder, JAS Ankle, JAS Knee, JAS Wrist, and JAS Pronation-Supination) and Air Cast®.
  • Patient-actuated serial stretch (PASS) devices - allow resisted active and passive motion (elastic traction) within a limited range. PASS devices supply a low to high-level load to the joint, using pneumatic or hydraulic systems that can be adjusted by the patient. Examples include the ERMI Knee Extensionater®, ERMI Elbow Extensionater®, ERMI Knee/Ankle Flexionater®, and ERMI Shoulder Flexionater®.

Dynamic stretching devices are intended to stretch joints that have reduced range of motion secondary to immobilization, surgery, contracture, fracture, dislocation, or a number of additional non-traumatic disorders.  These devices are intended to replace, reduce, or supplement the number of physical therapist-directed sessions by providing frequent and controlled joint mobilization in a hospital or in the patient's home. The goal is to cause permanent elongation of the connective tissue in order to increase range of motion. 

They are spring-loaded, adjustable devices designed to provide low-load prolonged stretch commonly 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.


 

Policy

Mechanical stretching devices for joint stiffness or contracture may be considered 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 but less than 4 months after injury or surgery); or
  2.  In the acute post-operative period for members who have a prior documented history of motion stiffness/loss in a joint and are having additional surgery or procedures done to improve motion to that joint.

The use of mechanical stretching devices in the management of chronic contractures(no significant change in motion 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 is considered not medically necessary.

Dynamic (LLPS) devices are considered medically necessary for use on the knee, elbow, wrist or finger in any of the following clinical settings:

  1. As an addition to physical therapy in the subacute injury or post-operative period (≥ 3 weeks but ≤ 4 months after injury or operation) in patients with signs and symptoms of persistent joint stiffness.
  2. In the acute post-operative period for patients who are undergoing additional surgery to improve the range of motion of a previously affected joint.
  3. For patients unable to benefit from standard physical therapy modalities because of an inability to exercise for as long as four months to see if improvement occurs, and then for as long as improvement can be documented.

Dynamic (LLPS) devices are considered not medically necessary for patients unable to benefit from standard physical therapy modalities because of an inability to exercise after documentation of no improvement despite use for 4 months.

If there is no significant improvement after four months of use, dynamic (LLPS) devices are considered not medically necessary.Dynamic (LLPS) devices are considered investigational for use on any other joint or any other condition not listed above, including but not limited to the management of chronic joint stiffness and/or chronic or fixed contractures.Bi-directional static progressive (SP) stretch devices are considered investigational.Patient-actuated serial stretch (PASS) devices are considered investigational.


 

Rationale

Dynamic (LLPS) devices
Although there are inadequate data in the published peer reviewed literature to validate the effectiveness of dynamic splinting in improving joint range of motion (ROM), this technology is widely used in the orthopedic and physical therapy communities for selected patient populations. On the basis of national community standards, dynamic splinting may be considered medically necessary in the clinical settings outlined under the Policy section of this document. Due to a lack of scientific evidence demonstrating effectiveness of this technology, it is considered investigational and not medically necessary for use in the management of other joints, chronic joint stiffness, and/or contractures.

Bi-directional static progressive (SP) stretch devices
Static progressive stretch devices do not have published scientific literature validating their effectiveness. Research is limited to case reports and small uncontrolled studies.  There is no evidence that static progressive stretch devices whose method is similar to manual therapy, significantly improve clinical outcomes. Use of these devices has not given rise to a community standard.Patient-actuated serial stretch (PASS) devices
In 2003 Branch et al. conducted a prospective study to determine the effectiveness of using patient-controlled home mechanical therapy to increase knee ROM in patients with knee contracture.  The sample size included 34 patients who had failed to reach full ROM with a 6-week regimen of conventional physical therapy.  Patients included those who developed knee contractures following anterior cruciate ligament (ACL) injury (n =14), peripatellar injury (n =7), fracture (n =4), and other, unspecified causes (n =9). These patients used a patient-controlled device (the ERMI Knee/Ankle Flexionater®) four to eight times daily for 15 minutes.  The duration of the treatment ranged from two to 12 weeks.  Thirty-one (91.2%) of these patients regained functional flexion after 6.7 weeks. Full ROM was regained by 74% of the patients and mean knee flexion progressed from 70.8 degrees to 130.6 degrees. Two patients in this study required surgical manipulation. Conclusions regarding this study are limited by the small sample size and lack of a control group.  Furthermore, due to the overall lack of published studies investigating PASS devices, no conclusion can be drawn regarding their efficacy.

 

References:

  1. Hepburn GR, Crivelli KJ.  Use of elbow Dynasplint for reduction of elbow flexion contractures: A case study.  J Orthop Sports Phys Ther. 1984; 5(5):269-274.
  2. Hepburn GR. Case Studies: Contracture and Stiff joint Management with Dynasplint. J of Orthopedic and Sports Physical Therapy 1987: 498-504.
  3. Chow JA, Thomes LJ, Dovelle S, et al. Controlled motion rehabilitation after flexor tendon repair and grafting. J Bone Joint Surg. 1988; 70-B (4):591-595.
  4. Brown EZ, Ribik CA. Early dynamic splinting for extensor tendon injuries. J Hand Surg. 1989; 14A:72-76.  
  5. 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; 14B:18-20.  
  6. Kerr CD, Burczak JR. Dynamic traction after extensor tendon repair in zone 6, 7, and 8: A retrospective study. J Hand Surg. 1989; 14B:21-25.
  7. MacKay-Lyons M. Low-load, prolonged stretch in treatment of elbow flexion contractures secondary to head trauma: a case report.  Physical Therapy 1989; 69(4): 292-296.
  8. Hung LK, Chan A, Chang J, et al. Early controlled active mobilization with dynamic splintage for treatment of extensor tendon injuries. J Hand Surg. 1990; 15A (2):251-257. .
  9. Blair WF, Steyers CM. Extensor tendon injuries. Orthop Clin North Am. 1992; 23(1):141-148.
  10. Bonutti PM, Windau JE, Ables BA, et al. Static progressive stretch to reestablish elbow range of motion. Clin Orthop. 1994; 303: 128-134.
  11. Joint Active Systems, Inc. JAS OnLine (website). Effingham, IL: Joint Active
     Systems, 2002; available at http://www.jointactivesystems.com.
  12. 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, 2002; 27(3):283-8.
  13. 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.
  14. Berlet GC, Andereson RB, Kiebzak GM, et al.  A prospective trail of night splinting in the treatment of recalcitrant plantar fasciitis: the Ankle Dorsiflexion Dynasplint.  Orthopedics 2002; 25(11):1273-1275.
  15. Branch TP, Karsch RE, Mills TJ, Palmer MT. Mechanical Therapy for Loss of KneeFlexion. Am J Orthop, 2003; 32(4):195-200.
  16. 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.
  17. 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://lni.wa.gov/ClaimsIns/default.asp
  18. 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.
  19. Thien TB, Becker JR, Theis J-C. Rehabilitation after surgery for flexor tendon injuries in the hand. The Cochrane Library (ISSN 1464-780X) 2006;4. Available online at: http://www.cochrane.org/reviews/en/ab003979.html
  20. Farmer SE, Woollam PJ, Patrick JH, et al. Dynamic orthoses in the management of joint contracture. J Bone Joint Surg Br. 2005;87(3):291-5.
  21. Mont MA, Seyler TM, Marulanda GA, et al.  Surgical treatment and customized rehabilitation for stiff knee arthroplasties. Clin Orthop Relat Res. 2006; 446:193-200.
  22. Premera Blue Cross Corporate Medical Policy 1.01.514 , Stretching Devices for Joint Stiffness and Contracture
  23. Anthem Medical Policy DME.00028, Stretching Devices for Joint Stiffness and Contracture

Web sites for additional information:

 

Dynasplint Systems, Inc. Products. .Available at: http://www.dynasplint.com Accessed on December 24, 2008. 

ERMI Inc. Available at: http://www.getmotion.com/index.htm  Accessed on December 24, 2008.

ERMI Inc. Available at: http://www.getmotion.com/index.htm  Accessed on May 16, 2007.

Joint Active Systems, Inc. Available at: http://www.jointactivesystems.com. Accessed on December 24, 2008.

Ultraflex Systems Inc. Available at:  http://www.ultraflexsystems.com.  Accessed on December 24, 2008.
 

Codes

Number

Description

ICD-9 Diagnosis 715.00-715.98 Osteoarthritis and allied disorders
  716.00-716.99 Other and unspecified arthropathies
  717.0-717.9 Internal derangement of knee
  718.00-718.99 Other derangement of knee
  719.00-719.99 Other and unspecified disorders of joint; effusion, hemarthrosis, pain in joint, difficulty in walking
  813.00-813.93 Fractures of radius and ulna
  814.00-818.1 Fractures; carpal bones, metacarpal bones, one or more phalanges, multiple fractures, ill-defined fractures of upper limb
  822.0-822.1 Fracture of patella
  832.00-833.19 Dislocation; elbow, wrist
  836.0-836.69 Dislocation of knee
  841.0-842.19 Sprains and strains; wrist, hand, elbow, forearm
  844.0-844.9 Sprains and strains; knee, leg
  959.-959.5 Injury, other/unspecified; elbow, forearm, wrist, finger
  959.7 Injury, other/unspecified; knee, leg, ankle, foot
HCPCS  E1800 Dynamic adjustable elbow extension/flexion device, includes soft surface 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, extension and/or flexion, 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, extension and/or flexion, with or without range of motion adjustment, includes all components and accessories
  E1818 Static progressive stretch forearm device, extension and/or flexion, 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
  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

 


Index

Bidirectional Static Progressive Splint
Dynamic Splinting
Dynasplint
ERMI
JAS
PASS
Patient-Actuated Serial Stretch (PASS) Splint
Spring Loaded Dynamic Splinting
Static Progressive Stretch Splint
Static Splint
Ultraflex

 


Policy History

Date Action Reason
09/11/08 Add policy to DME section New policy