Patient-Controlled End Range of Motion Stretching Devices

POLICY NUMBER

A.1.03.05

DESCRIPTION

Patient-controlled stretching devices are used at home to increase range of motion in individuals who have impaired functional status due to decreased range of motion. Two types of commercially available devices are addressed in this policy. Static progressive stretch devices (eg, Joint Active Systems, 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 (eg, End Range of Motion Improvement (ERMI)) use hydraulics to alternate between periods of higher intensity stretch and relaxation.

Range of Motion Impairments

Loss of full range of motion 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 for 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 range of motion compared with the normal contralateral side. Loss of knee range of motion can lead to impairments in walking, sitting, rising from a chair, and navigating stairs. A 2010 publication 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 are designed to be worn over relatively long periods (ie, 6 to 8 hours or overnight). 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.

This policy focuses on patient-controlled mechanical devices that provide either moderate- to high-intensity stretch or static progressive stretch in the home. Patient-controlled stretching devices are used at home to increase range of motion in patients who have impaired functional status due to decreased range of motion. Two types of commercially available devices are addressed in this policy. Static progressive stretch devices (eg, Joint Active Systems, 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 (eg, End Range of Motion Improvement) use hydraulics to alternate between periods of higher intensity stretch and relaxation.

Improvement in functional outcomes, such as the ability to perform activities of daily living, is the primary goal of this intervention. Joint range of motion is an intermediate outcome. In 2000, one small study correlated knee range of motion with functional parameters and concluded that 110° is considered the functional range of motion necessary to allow patients to perform common activities of daily living such as navigating stairs, risingfrom a low chair or commode, entering or exiting from a car, or tying one’s shoes. This threshold of range of motion is therefore used as a measure of treatment success for individual patients. Loss of knee range of motion 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 noninvolved 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.” Range of motion thresholds in joints other than the knee have been less clearly defined.

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

POLICY

Patient-controlled end range of motion stretching devices (static progressive and serial) are considered investigational.

POLICY EXCEPTIONS

None 

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

04/09/2015: Approved by Medical Policy Advisory Committee.

08/03/2015: Code Reference section updated for ICD-10.

05/31/2016: Policy number A.1.03.05 added.

08/23/2016: Policy title changed from "Patient-Actuated End Range Motion Stretching Devices" to "Patient-Controlled End Range of Motion Stretching Devices." Policy description updated regarding devices. Policy statement updated to change "patient-actuated" to "patient-controlled."

03/24/2017: Policy description updated regarding devices. Policy statement unchanged.

04/03/2018: Policy description updated regarding outcome measures. Policy statement unchanged.

04/03/2019: Policy reviewed; no changes.

04/14/2020: Policy description updated. Policy statement unchanged.

05/24/2021: Policy description updated regarding regarding devices. Policy statement unchanged.

05/06/2022: Policy reviewed; no changes.

04/12/2023: Policy reviewed. Policy statement updated to add "static progressive and serial."

04/16/2024: Policy reviewed; no changes.

04/01/2025: Code Reference section updated to add new HCPCS code E1832, effective 04/01/2025.

04/16/2025: Policy description updated. Policy statement unchanged.

SOURCE(S)

Blue Cross and Blue Shield Association Policy # 1.03.05

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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