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Patient Controlled End Range Motion Stretching Devices

Policy Number: MP-578

Latest Review Date: March 2021

Category:  DME 

Policy Grade:  B

POLICY:

The use of bi-directional static progressive (SP) stretch devices are considered investigational.

The use of patient-actuated serial stretch (PASS) is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Patient-controlled stretching devices are used at home to increase range of motion (ROM) in patients who have impaired functional status due to decreased ROM. We address two types of commercially available devices. Static progressive stretch (SPS) devices (e.g., JAS, Static-Pro) provide low- to moderate-intensity stretching with a crank or ratchet that progressively increases the stretch within each session, and serial stretch devices (e.g., ERMI) use hydraulics to alternate between periods of higher intensity stretch and relaxation.

Range of Motion Impairments

Loss of full range of motion (ROM) occurs in a significant proportion of patients following surgical procedures around a joint, such as total knee arthroplasty or anterior cruciate ligament reconstruction. The most common cause of severe postoperative motion loss is the development of intra-articular or extra-articular arthrofibrosis. Arthrofibrosis, characterized by periarticular fibrosis and bands of scar tissue, is described as a painful loss of end ROM compared with the normal contralateral side. Loss of knee ROM can lead to impairments in walking, sitting, rising from a chair, and navigating stairs. Stephenson et al (2010) estimated that, based on the annual rates of total knee arthroplasty and anterior cruciate ligament reconstruction, the number of major knee surgery patients affected by arthrofibrosis in the United States would be at least 85,000 per year, and approximately 21,000 patients each year would be at risk of requiring additional surgery.

Treatment

Treatment of arthrofibrosis may include physical therapy, manipulation under anesthesia, arthroscopic or open lysis of adhesions, or revision surgery. Conservative treatment typically consists of postoperative physical therapy with pressure stretching techniques and home exercises. When rehabilitation has failed, serial casting, static braces, or dynamic splints that provide low-load prolonged stretch may be used. Dynamic splints use spring loading or elastic bands to provide low-intensity tension (less than that exerted by a physical therapist) and designed to be worn over relatively long periods (i.e., 6-8 hours or overnight).

This evidence review focuses on patient-controlled mechanical devices that provide either moderate- to high intensity stretch or static progressive stretch (SPS) in the home. The efficacy of a stretching regimen to permanently remodel tissue is considered to be a function of the intensity, length of the session, number of sessions per day, and number of days per week that stretching is performed. SPS devices provide a low- to moderate-intensity force to hold a joint at its end range and gradually increase the stretch. In contrast to the long periods of low-intensity stretch provided by dynamic splinting devices, patient-controlled serial stretch and SPS devices are designed to be used for 15 to 30 minutes, in up to 8 sessions per day.

Improvement in functional outcomes, such as the ability to perform activities of daily living, is the primary goal of this intervention. Joint ROM is an intermediate outcome. One small study (2000) correlated knee ROM with functional parameters and concluded that 110° is considered the functional ROM necessary to allow patients to perform common activities of daily living such as navigating stairs, rising from a low chair or commode, entering or exiting from a car, or tying one’s shoes. This threshold of ROM is therefore used as a measure of treatment success for individual patients. Loss of knee ROM of more than 15°, which occurs in about 1% to 2%

of patients after anterior cruciate ligament reconstruction, has been associated with loss of quadriceps muscle strength and the development of osteoarthritis. According to the knee examination form developed by the International Knee Documentation Committee (2000), an extension deficit of 6° to 10° or a flexion deficit of 16° to 25° when compared with the non-involved knee is categorized “abnormal,” and an extension deficit of more than 10° or a flexion deficit of more than 25° when compared with the noninvolved knee is categorized “severely abnormal.” ROM thresholds in joints other than the knee have been less clearly defined.

For dynamic low load prolonged duration stretch (LLPS) devices, see Medical Policy 346- “Stretching and Splinting Devices for the Treatment of Joint Stiffness and Contractures”.

KEY POINTS:

The most recent literature update was performed through January 26, 2021.

SUMMARY OF EVIDENCE:

For individuals who have functional limitations in ROM who receive SPS devices and physical therapy, the evidence includes RCTs, a systematic review, and case series. Relevant outcomes include symptoms, change in disease status, functional outcomes, and quality of life. Three RCTs have evaluated SPS devices, but comparators in each differed (physical therapy, a dynamic splint, and a serial stretch device). One RCT reported significant improvements in Disabilities of the Arm Shoulder and Hand questionnaire scores and shoulder ROM compared with physical therapy alone at the end of 4 weeks of treatment, with significant improvements maintained at the 2-year follow-up. A second RCT evaluating SPS in the elbow found similar improvements in most ROM outcomes compared with dynamic splinting, except better Disabilities of the Arm Shoulder and Hand scores in the SPS group at 6 months and better flexion contracture in the dynamic splinting group at 12 months. A third RCT, which compared SPS with serial stretch devices, found greater improvements in Western Ontario and McMaster University Osteoarthritis Index and knee flexion scores with the serial stretch devices. A systematic review and meta-analysis of case reports and series found that similar clinical efficacy for increasing elbow ROM and flexion can be achieved using dynamic splints, SPS devices, and static braces. It is not known whether patient compliance is higher with SPS devices because results have indicated these devices improve ROM faster than comparators. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have functional limitations in ROM who receive serial stretch devices and physical therapy, the evidence includes an RCT and observational studies. Relevant outcomes include symptoms, change in disease status, functional outcomes, and quality of life. The best evidence consists of serial stretching with ERMI devices used to treat knee ROM. One small RCT and a larger retrospective comparative study have reported that high-intensity stretching with ERMI devices improved ROM more than lower intensity stretching devices in patients who were post injury or surgery. Other available data consist of retrospective case series that have demonstrated improved ROM in patients whose ROM had plateaued with physical therapy. The clinical significance of gains in this surrogate outcome measure is unclear. Further high-quality comparative trials are needed to determine whether these patient-controlled devices improve functional outcomes better than alternative treatments and identify the patient populations that might benefit. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

PRACTICE GUIDELINES AND POSITION STATEMENTS:

No guidelines or statements on patient-actuated end-range motion devices were identified.

U.S. Preventive Services Task Force Recommendations:

Not applicable.

KEY WORDS:

Bi-directional static progressive (SP) stretch devices, patient-actuated serial stretch (PASS) devices, FlexPro Knee Flexor, StaticPro® Knee, ERMI (End Range Motion Improvement), Joint Active Systems (JAS), patient-controlled mechanical devices, Stat-A-Dyne® (Ortho-Innovations), AliMed® Turnbuckle Orthosis (Alimed), and Mayo Aircast®, Advance Dynamic ROM, DeROM, Dynasplint, EMPI advance, LMB Pro-glide, Pro-glide Dynamic ROM, SaeboFlex, SaeboReach, Ultraflex.

APPROVED BY GOVERNING BODIES:

The FDA has determined that devices classified as “Exerciser, Non-Measuring” are class I devices by the U.S. Food and Drug Administration (FDA) and are exempt from 510(k) requirements. This classification does not require submission of clinical data on efficacy, only notification to FDA prior to marketing.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

HCPCS

E1399

Durable Medical Equipment Miscellaneous

E1801

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

E1806

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

E1811

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

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

E1821

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

E1831

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

E1841

Static progressive stretch shoulder device, with or without range of motion adjustment, includes all components and accessories.

                   

REFERENCES:

  1. Bonutti PM, McGrath MS, Ulrich SD, et al. Static progressive stretch for the treatment of knee stiffness. Knee. Aug 2008; 15(4):272-276.
  2. Branch TP, Karsch RE, Mills TJ, et al. Mechanical therapy for loss of knee flexion. Am J Orthop (Belle Mead NJ). Apr 2003; 32(4):195-200.
  3. Dempsey AL, Branch TP, Mills T, et al. High-intensity mechanical therapy for loss of knee extension for worker's compensation and non-compensation patients. Sports Med Arthrosc Rehabil Ther Technol. 2010; 2:26.
  4. Dempsey AL, Mills T, Karsch RM, et al. Maximizing total end range time is safe and effective for the conservative treatment of frozen shoulder patients. Am J Phys Med Rehabil. Sep 2011; 90(9):738-745.
  5. Doornberg JN, et al.  Static progressive splinting for post-traumatic elbow stiffness. Journal of Orthopedic Trauma, July 2006; 20(6): 400-404.
  6. Hussein AZ, Ibrahim MI, Hellman MA, et al. Static progressive stretch is effective in treating shoulder adhesive capsulitis: Prospective, randomized, controlled study with a two-year follow-up. Eur J Physiother. 2015; 17(3):138-147.
  7. Ibrahim M, Donatelli R, Hellman M, et al. Efficacy of a static progressive stretch device as an adjunct to physical therapy in treating adhesive capsulitis of the shoulder: a prospective, randomised study. Physiotherapy. Sep 2014; 100(3):228-234.
  8. Ibrahim MI, Johnson AJ, Pivec R, et al. Treatment of adhesive capsulitis of the shoulder with a static progressive stretch device: a prospective, randomized study. J Long Term Eff Med Implants. 2012; 22(4):281-291.
  9. International Knee Documentation Committee. International Knee Documentation Committee criteria. 2000; www.sportsmed.org/Research/IKDC_Forms/. Accessed February 8, 2020.
  10. Jacobs CA, Sciascia AD. Factors that influence the efficacy of stretching programs for patients with hypomobility. Sports Health. Nov 2011; 3(6):520-523.
  11. Johnson et al. Assessment of Static Progressive Stretch for the Treatment of Shoulder Stiffness: A Prospective Case Series. Journal of Long-Term Effects of Medical Implants, 2012; 22(4): 293-303.
  12. 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. Apr 18 2012; 94(8):694-700.
  13. Lucado AM, Li Z, Russell GB, et al. Changes in impairment and function after static progressive splinting for stiffness after distal radius fracture. J Hand Ther. Oct-Dec 2008; 21(4):319-325.
  14. 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.
  15. McGrath MS, Ulrich SD, Bonutti PM, et al. Static progressive splinting for restoration of rotational motion of the forearm. J Hand Ther. Jan-Mar 2009; 22(1):3-8; quiz 9.
  16. Muller AM, Sadoghi P, Lucas R, et al. Effectiveness of bracing in the treatment of nonosseous restriction of elbow mobility: a systematic review and meta-analysis of 13 studies. J Shoulder Elbow Surg. Aug 2013; 22(8):1146-1152.
  17. Papotto BA, Mills T. Treatment of severe flexion deficits following total knee arthroplasty: a randomized clinical trial. Orthop Nurs. Jan-Feb 2012; 31(1):29-34.
  18. Rowe PJ, Myles CM, Walker C, et al. Knee joint kinematics in gait and other functional activities measured using flexible electrogoniometry: how much knee motion is sufficient for normal daily life? Gait Posture. Oct 2000; 12(2):143-155.
  19. Schwartz, D. Static progressive orthoses for the upper extremity: a comprehensive literature review. American Association for Hand Surgery, 2012; 7:10-17.
  20. Shelbourne KD, Gray T. Minimum 10-year results after anterior cruciate ligament reconstruction: how the loss of normal knee motion compounds other factors related to the development of osteoarthritis after surgery. Am J Sports Med. Mar 2009; 37(3):471-480.
  21. Sodhi N, Yao B, Anis HK, et al. Patient satisfaction and outcomes of static progressive stretch bracing: a 10-year prospective analysis. Ann Transl Med. 2019 Feb;7(4).
  22. 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. May 2010; 26(5):1109-1118.
  23. 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. Mar 2010; 19(2):196-201.

POLICY HISTORY:

Medical Policy Group, January 2009 (3)

Medical Policy Administration Committee, July 2009

Medical Policy Group, September 2009 (3)

Medical Policy Administration Committee, October 2009

Available for comment October 3-November 17, 2009

Medical Policy Group, December 2009 (3)

Medical Policy Group, December 2010 – Add CPT Code effective Jan 1, 2011

Medical Policy Group, April 2011 – Added Key Points, Key Word, and References

Medical Policy Group, February 2012 (3): Added new devices in Policy Section.

Medical Policy Administration Committee, February 2012

Medical Policy Group, May 2013: Effective 05/1/2013: Active Policy but no longer scheduled for regular literature reviews and updates.

Medical Policy Group, September 2013 (2): Added new Key Word ‘FlexPro Knee Flexor’

Medical Policy Group, August 2014 (5): Added References; no change to policy statement.

Medical Policy Panel, January 2015

Medical Policy Group, January 2015 (6):  2015 Update:  Creation of individual policy with all references related to Patient-actuated End Range Motion Stretching Devices from Medical Policy #346; Update to Key Points, Key Words and References; no change in Policy Statement

Medical Policy Panel, July 2016

Medical Policy Group, July 2016 (6): 2016 Updates to Policy Title, Description, Key Points, Key Words, Approved by Governing Bodies and References. No change to policy statement.

Medical Policy Panel, March 2017

Medical Policy Group, March 2017 (6): Updates to Description, Key points and Summary. No change to policy intent.

Medical Policy Group, April 2017 (6): Updates to coding, added E1399 Durable Medical Equipment Miscellaneous

Medical Policy Panel, March 2018

Medical Policy Group, April 2018 (6): Updates to Description and Key Points.

Medical Policy Panel, March 2019

Medical Policy Group, March 2019 (6): Updates to Description and Key Points. No change to policy statement.

Medical Policy Panel, March 2020

Medical Policy Group, March 2020 (6): Updates to Description, Key Points and References.

Medical Policy Panel, March 2021

Medical Policy Group, March 2021 (6): Updates to Key Points. Policy statement updated to remove “not medically necessary,” no change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.