Coverage Policy Manual
Policy #: 1997041
Category: Rehabilitation
Initiated: July 1993
Last Review: April 2024
  Orthopedic Postoperative Rehabilitative Devices in the Home Setting (eg. CPM; ROMTech®)

Description:
Continuous passive motion (CPM) devices are utilized to keep a joint in motion without patient assistance. CPM is being evaluated for treatment and post-surgical rehabilitation of the upper and lower limb joints and for a variety of musculoskeletal conditions. Other rehabilitative equipment with clinician remote monitoring and adjustment capabilities have also been developed to provide range of motion exercise post joint surgery.
 
Physical therapy of joints following surgery focuses both on passive motion to restore mobility and active exercises to restore strength. While passive motion can be administered by a therapist, continuous passive motion (CPM) devices have also been used. Continuous passive motion is thought to improve recovery by stimulating the healing of articular tissues and circulation of synovial fluid; reduce local edema; and prevent adhesions, joint stiffness or contractures, or cartilage degeneration (O’Driscoll, 2000). CPM has been most thoroughly investigated in the knee, particularly after total knee arthroplasty or ligamentous or cartilage repair, but its acceptance in the knee joint has created interest in extrapolating this experience to other weight-bearing joints (i.e., hip, ankle, metatarsals) and non-weight-bearing joints (i.e., shoulder, elbow, metacarpals, and interphalangeal joints). Use of CPM in stroke and burn patients is also being explored.
 
The device moves the joint (e.g., flexion/extension), without patient assistance, continuously for extended periods of time, i.e., up to 24 hours/day. An electrical power unit is used to set the variable range of motion (ROM) and speed. The initial settings for ROM are based on a patient’s level of comfort and other factors that are assessed intra-operatively. The ROM is increased by 3–5 degrees per day, as tolerated. The speed and range of motion can be varied, depending on joint stability. The use of the devices may be initiated in the immediate postoperative period and then continued at home for a variable period of time.
 
Over the past 10 to 20 years, hospital lengths of stay have progressively shortened and, in some cases, surgical repair may be done either as an outpatient or with a length of stay of 1 to 2 days. As a result, there has been a considerable shift in the rehabilitation regimen, moving from an intensive in-hospital program to a less intensive outpatient program. Some providers may want patients to continue CPM in the home setting as a means of duplicating services offered with a longer (7-day) hospital stay.
 
The focus of the current review is to examine the literature on the use of CPM in the home setting as it is currently being prescribed postoperatively. Relevant comparisons are treatment outcomes of CPM when used alone or with PT, compared with PT alone.
 
Regulatory Status
Continuous passive motion (CPM) devices are considered class I devices by FDA and are exempt from 510(k) requirements. This classification does not require submission of clinical data regarding efficacy but only notification of the FDA before marketing. FDA product code: BXB.
 
The U.S. Food and Drug Administration identifies the ROMTech PortableConnect® and ROMTech AccuAngle® device as an isokinetic testing and evaluation system (product code IKK) which the FDA exempts from the premarket notification approval (FDA, 2020).
 

Policy/
Coverage:
Home exercise equipment is a contract exclusion in some member benefit certificates of coverage. The following Policy/Coverage statements apply to those members with contracts without these limitations and exclusions.
 
Effective July 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Use of Continuous Passive Motion Devices meets primary coverage criteria that there be scientific evidence of effectiveness for:
 
    • total knee replacement procedures;
    • reconstruction of the anterior cruciate ligament;
    • supracondylar fracture of the femur extending into the knee joint; and
    • intra-articular cartilage repair procedures of the knee (e.g., microfracture, osteochondral grafting, autologous chondrocyte implantation, treatment of osteochondritis dissecans, repair of tibial plateau fractures).
 
Use of the device must commence within two days following surgery.  Coverage is limited to that  portion of the three week period following surgery during which the device is used in the patient's  home. (There is insufficient evidence to justify coverage of these devices for longer periods of  time or for other applications.)
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Use of Continuous Passive Motion Devices for treatment of other joint problems does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.  
 
For members with contracts without primary coverage criteria, use of Continuous Passive Motion Devices for treatment of other joint problems is considered investigational treatment. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
The use of home exercise equipment with or without remote monitoring or adjustment capabilities (eg, ROMTech PortableConnect® and ROMTech AccuAngle®) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for all indications.
 
For members with contracts without primary coverage criteria, the use of home exercise equipment with or without remote monitoring or adjustment capabilities (eg, ROMTech PortableConnect® and ROMTech AccuAngle®) is considered investigational for all indications. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
 
Effective September 2010 - June 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Use of Continuous Passive Motion Devices meets primary coverage criteria that there be scientific evidence of effectiveness for:
 
    • total knee replacement procedures;
    • reconstruction of the anterior cruciate ligament;
    • supracondylar fracture of the femur extending into the knee joint; and
    • intra-articular cartilage repair procedures of the knee (e.g., microfracture, osteochondral grafting, autologous chondrocyte implantation, treatment of osteochondritis dissecans, repair of tibial plateau fractures).
 
Use of the device must commence within two days following surgery.  Coverage is limited to that  portion of the three week period following surgery during which the device is used in the patient's  home. (There is insufficient evidence to justify coverage of these devices for longer periods of  time or for other applications.)
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Use of Continuous Passive Motion Devices for treatment of other joint problems does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.  
 
For members with contracts without primary coverage criteria, use of Continuous Passive Motion Devices for treatment of other joint problems is considered investigational treatment. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective August 2001-August 2010
Until controlled trial studies are published, coverage for Continuous Passive Motion Devices will be limited to total knee replacement procedures,  reconstruction of the anterior cruciate ligament, and supracondylar fracture of the femur extending into the knee joint under the following guidelines:
    • Use of the device must commence within two days following surgery;
    • Coverage is limited to that portion of the three week period following surgery during which the device is used in the patient's home. (There is insufficient evidence to justify coverage of these devices for longer periods of time or for other applications.)
 
For Member Benefit Contracts or Plans with Primary Coverage Criteria, Continuous Passive Motion Device for treatment of other joint problems is not covered because they fail to meet the Primary Coverage Criteria (“The Criteria”) of the applicable benefit certificate or health plan. (The Criteria require, among other things, that there be scientific evidence of effectiveness, as defined in The Criteria.  The Criteria exclude coverage of treatments, such as Continuous Passive Motion Device for treatment of other joint problems for which there is lack of scientific evidence).
 
For Member Benefit Contracts or Plans with explicit exclusion language for experimental or investigational services, Continuous Passive Motion Device for treatment of other joint problems is not covered because it is considered experimental or investigational treatment, as defined in the applicable benefit contract or health plan, which excludes coverage of experimental or investigational treatment or services.
 
Effective July 1993 – July 2001
Continuous Passive Motion Devices have been developed for treatment of a number of joint, muscle, and tendon problems. There is fairly extensive medical literature on continuous passive motion, but there are few controlled studies available. Until controlled trial studies are published, coverage for Continuous Passive Motion Devices will be limited to total knee replacement procedures and reconstruction of the anterior cruciate ligament under the following guidelines:  (1) Use of the device must commence within two days following surgery; (2) Coverage is limited to that portion of the three week period following surgery during which the device is used in the patient's home. (There is insufficient evidence to justify coverage of these devices for longer periods of time or for other applications.)
 
Continuous Passive Motion Device for treatment of other joint problems is not covered due to lack of medical data attesting to the effectiveness and is considered investigational.
 

Rationale:
2002-2003 Update
The focus of this update is to examine the literature regarding home use of CPM. It specifically examines the treatment outcome of CPM when used alone or when used in addition to conventional physical therapy compared to active or passive physical therapy alone, as administered by a physical therapist or other caregiver in the home setting. While CPM may be commonly used in the hospital setting, this aspect of its use is not as relevant to medical policy issues compared to its use in the home setting. In fact, early studies of CPM machines focused on their use in the hospital setting, where frequently the impact on length of stay was considered a key clinical outcome.
 
For this update, a literature review based on the MEDLINE database was performed for the period of 1996 to September 2003. The literature search focused on randomized trials of CPM used in the home settings. The majority of studies identified focused on the use of CPM in the knee. The following discussion first focuses on the knee, followed by a review of literature regarding CPM of other joints.
 
Knee
Anterior Cruciate Ligament Repair and Autologous Chondrocyte Transplantation
The literature search did not identify any additional randomized controlled trials of CPM after repair of the anterior cruciate ligament in any setting—either acute hospital or in the home setting. Over the past 10 years, hospital lengths of stay have progressively shortened, and in some cases ACL repair may be done either as an outpatient or with a length of stay of 1–2 days. Therefore, with early discharge, some providers may wish to continue CPM in the home as a means of duplicating the services offered with a longer (7-day) hospital stay. Therefore, the studies of CPM after ACL repair in the immediate postoperative period may possibly be relevant to the home setting for patients who are discharged with an abbreviated hospital stay. CPM in the immediate postoperative period as an adjunct to conventional physical therapy offered no demonstrable advantage over conventional physical therapy alone. CPM has also been included in the postoperative management of patients undergoing autologous chondrocyte transplantation. No published data were identified that addressed this application of CPM.
 
Total Knee Arthroplasty (TKA)
A study by Worland and colleagues was the only identified controlled study that compared the use of CPM and active physical therapy in the home setting. In this study, 80 patients undergoing TKA were randomly assigned to receive, at discharge, home CPM (3 hours/day for 10 days) versus active physical therapy, as offered by professional physical therapists.  The vast majority of studies have examined CPM as an adjunct to active physical therapy; therefore, this study is unique in that CPM is proposed as an alternative. At 2 weeks, knee flexion was similar in the 2 groups, but a flexion contracture was noted in 1 patient in the CPM only group. At 6 months, no differences were found in knee scores or knee flexion.
 
Chen and colleagues randomized 51 patients in an inpatient rehabilitation service who had undergone TKA to receive either conventional active physical therapy or physical therapy plus CPM.  Referral to the rehabilitation center was made 5–6 days after surgery, and the majority had received CPM as part of the initial hospitalization. Knee flexion was the principal outcome. No significant difference was noted in range of passive motion between the 2 groups, as measured on admission, on the third and seventh hospital days, and at the time of discharge (8 days after admission). The authors concluded that the use of CPM in the rehabilitation hospital offered no added benefit. While a rehabilitation service does not duplicate the home environment, it does reflect the use of CPM beyond the initial acute hospitalization.
 
A variety of trials focused on the use of CPM in the hospital setting. In this setting, researchers have focused on whether the use of CPM is safe (i.e., whether or not it impacts on healing of tissues), what range of motion can be tolerated at what point in the postoperative recovery, and whether or not the use of CPM permits earlier hospital discharge by accelerating the recovery of range of motion. Although these studies are not relevant to the use of CPM in the home, they will be briefly reviewed here for completeness. Yashar and colleagues reported on a trial that randomized 178 patients undergoing TKA to CPM immediately in the postoperative period or to CPM 1 day after surgery. A small but statistically significant improvement in flexion was found at the time of discharge in those started on early CPM, but this difference did not persist at 4 weeks.  MacDonald and colleagues reported on a randomized trial focusing on immediate postoperative versus no postoperative CPM in a group of patients undergoing TKA.  Patients received a maximum of 24 hours with CPM. There were no differences in the treatment groups regarding range of motion, length of stay, or analgesic requirements. In the trial reported by Pope and colleagues, 53 patients were randomized either to 2 different schedules of CPM versus no CPM. The use of CPM was not associated with improved function or range of motion.  Kumar and colleagues randomized 73 patients who had undergone TKA to receive either CPM in the immediate postoperative period versus protocol of early passive flexion referred to as the "drop and dangle" technique.  Patients assigned to the drop and dangle technique were discharged from the hospital earlier and also had a statistically better extension range at 6 months compared to the CPM group. Therefore, the use of CPM after TKA, even in the acute care setting, still appears to be controversial.
 
CPM after TKA was the subject of a 2003 Cochrane review.  This review reported that CPM combined with physical therapy was found to statistically significantly increase active knee flexion and decrease length of stay. The Cochrane review noted that studies focused on the role of CPM in the immediate postoperative period.
 
Hip
The literature search did not identify any controlled studies focusing on CPM of the hip after surgical intervention. As noted here, the success of CPM in the knee is still controversial, and it is unclear whether or not any treatment success in the knee, a hinge joint with one plane of movement, can be extrapolated to the hip joint, a ball and socket joint with multiple planes of movement. One pilot study looked at the use of CPM of the hip in patients with osteoarthritis in the absence of surgical intervention.  This uncontrolled study examined the use of CPM for 1 to 7 hours daily for a 12-week trial. While improvements were noted in the patient's assessment of pain, a controlled trial is needed to validate this treatment effect, particularly in comparison to a program of regular walking.
 
Shoulder
Passive shoulder motion may be recommended after shoulder surgery, particularly after repair of the rotator cuff. Lastayo and colleagues reported on the results of a trial that randomized 31 patients undergoing rotator cuff repair to 1 of 2 types of postoperative management: a 4-week home program of continuous passive motion or manual passive range-of-motion exercises.  No significant difference in outcomes was observed between the 2 approaches, as measured by a self-administered questionnaire. Raab and colleagues also conducted a trial that randomized 26 patients to undergo postoperative physical therapy alone or physical therapy in addition to CPM.   Patients were evaluated with pre- and 3-month postoperative shoulder scores that incorporated pain, function, muscle strength, and range of motion. There was no significant improvement in shoulder score in the CPM group compared to the control group, although a significant improvement was found in the subscore of range of motion.
 
Elbow
No controlled studies were identified.
 
Metacarpophalangeal Joint Arthroplasty
Ring and colleagues examined the role of CPM in 15 hands (60 joints) undergoing silicone interposition arthroplasty of the metacarpophalangeal joint secondary to rheumatoid arthritis.  Patients were randomized to receive a 6-week protocol CPM plus the standard dynamic splint protocol versus the dynamic splint protocol alone. The authors did not identify any clear advantages of adding CPM to the standard protocol.
 
2006 Update
A search of the literature from 2003 through January 2006 did not identify any additional published clinical trials.
 
2007 Update
A search of the MEDLINE database for the period of January 2006 through June 2007 did not identify any literature that would support a change in the policy statement.
 
Efficacy in the early postoperative period has been cited to support the continued use of these devices in the home setting following early discharge. Although this policy addresses the use of CPM devices in the home, it is notable that a meta-analysis of older studies suggests that the benefits of CPM in a hospital setting may be small and only short term.  Two recent randomized controlled trials find that 2 hours of daily CPM in the hospital after total knee replacement does not improve postoperative outcomes at discharge or 1-year follow-up.  The lack of improvement with CPM in recent studies may be due to the current practice of permitting patients to mobilize or commence flexion immediately following surgery.
 
Another study compared passive motion versus immobilization following surgical treatment of idiopathic club foot in 38 infants (50 feet).  The infants were randomized to CPM (4 hours each day) or casting during days 10–42 following surgery. Blinded analysis showed improvements in the Dimeglio club foot score (9.7 to 3.1) that were significantly greater than the control group (10.3 to 4.2) through 12 months (97% follow-up). Between 12 and 18 months this trend reversed, and by 48 months after surgery there was no significant difference between the 2 groups. These recent results provide further support for the current policy statement.
 
CPM is also being studied as a means to aid recovery of motor skills following stroke. One study randomized 35 patients to daily sessions of CPM (25 min) or daily group therapy sessions consisting of self-range motion for post-stroke rehabilitation.  All patients also received standard post-stroke therapy for 3.5 hours per day. Following 20 days of therapy, there was a trend for greater shoulder joint stability in the passive motion group (n = 17, p < 0.06) compared with the control group (n=15). No statistically significant differences were found for measures of motor impairment. This study is limited by the small sample size and the short follow-up period; additional studies are needed to determine whether treatment with passive motion over a longer duration could aid in the recovery of motor skills following stroke.
 
Clinical practice guidelines from the French Physical Medicine and Rehabilitation Society conclude that there is not sufficient evidence to recommend substituting CPM for other rehabilitation techniques aimed at early mobilization after TKA.  The evidence review found no positive effect of CPM over intermittent early mobilization, at short or long-term follow-up.
 
2010 Update
A literature review was conducted through August 2010 on the use of CPM in the home setting.  There was no literature to support the use of CPM in joints other than the knee.
 
Dundar et al. compared CPM with physiotherapy in a randomized trial of 57 patients with adhesive capsulitis (frozen shoulder) (Dundar, 2009).  CPM or physiotherapy was provided for 1 hour per day (5 days a week) for 4 weeks. Pain and function were similar in the 2 groups at baseline, with visual analog scale (VAS) scores for pain ranging from 5.44 (at rest) to 6.34 (with movement). Assessments at baseline, 4, and 12 weeks showed improvements in pain and function in both groups. CPM resulted in better pain reduction than physiotherapy (at rest, 47% vs. 25%; with movement, 35% vs. 21%; and at night, 36% vs. 19%, all respectively). There were no differences between groups in range of motion or functional ability. Although this unblinded study provides some support for the inclusion of CPM in a physiotherapy program, additional studies are needed to evaluate CPM when provided at home.
 
Postoperative management of open elbow contracture release with CPM was assessed in a matched cohort study by Lindenhovius et al (Lindenhovius, 2009).  Sixteen patients who had used CPM after open contracture release and 16 patients who had not used CPM after surgery were matched for age, gender, diagnosis, range of motion, and radiographic appearance. Chart review was utilized when possible; patients who had insufficient follow-up in the medical record were invited back for follow-up and radiograph. Twenty-three patients (72%) were evaluated by an investigator who was not involved in their care. Improvements in range of motion were not different between the 2 groups for either early (410 months) or final (1056 months) evaluations.
 
Although no controlled clinical studies were identified that compared health outcomes with or without the use of CPM, CPM is used as a part of the rehabilitation protocol for as long as 6 weeks when weight bearing is restricted following autologous chondrocyte implantation (ACI) (Nugent-Derfus, 2007) (Salter, 1989) (Browne, 2005).  Basic research supports greater healing of articular cartilage of full-thickness defects that penetrate the subchondral bone than either immobilization or intermittent mobilization (Farr, 2007) (Rosenberger, 2008).  Based on expert opinion and the available literature, the coverage statement will be expanded to include coverage for intra-articular cartilage repair procedures of the knee (e.g., microfracture, osteochondral grafting, autologous chondrocyte implantation, treatment of osteochondritis dissecans, repair of tibial plateau fractures).
 
2012 Update
Rotator Cuff
Passive shoulder motion has been studied after shoulder surgery, particularly after repair of the rotator cuff. Du Plessis et al. published a systematic review of CPM following rotator cuff repair in 2011, with a literature search performed in 2009 (Du Plessis, 2011).  Three RCTs with a total of 113 patients were included in the review. A meta-analysis could not be conducted due to heterogeneity in populations studied, outcome measurements and tools, interventions and comparisons. Two of the RCTs included in this review were the studies by Lastayo et al. and Raab et al. discussed below (Lastayo, 1998; Raab, 1996). The third study included in the systematic review was a German language report that found a significant reduction of 12 days in the time to reach 90 degree abduction compared to a physiotherapy control group, with no significant difference in pain between the 2 groups.
 
The 2 RCTs included in the systematic review were small. Lastayo and colleagues reported the results of a trial that randomly assigned 31 patients undergoing rotator cuff repair to 1 of 2 types of postoperative management: a 4-week home program of CPM (average of 3 hours per day) or manual passive elevation and rotation exercises (Lastayo, 1998).  No significant difference in outcomes was observed between the 2 approaches. Raab and colleagues conducted a trial that randomly assigned 26 patients to undergo postoperative physical therapy alone or CPM in addition to physical therapy (Raab, 1996).  Patients were evaluated with pre- and 3-month postoperative shoulder scores that incorporated pain, function, muscle strength, and ROM. A significant improvement was found in the subscore of ROM, although there was no significant improvement in overall shoulder score in the CPM group compared to the control group. Both of these RCTs were likely underpowered to show differences on important clinical outcomes.
 
In 2010, Garofalo et al. reported another randomized study on the effects of CPM after rotator cuff repair (Garofalo, 2010).  All of the 100 patients underwent passive self-assisted ROM exercise, with additional use of CPM in roughly half of the patients for 2 hours per day (4 sessions of 30 min. each) over 4 weeks. The physiotherapist-supervised exercises included pendulum movements and progressive passive abduction, forward flexions, and external rotation. Otherwise, the shoulder was immobilized in a sling brace for 4 weeks after surgery. From the 5th to the 28th week, all patients underwent the same physical therapy protocol. ROM and VAS for pain were measured at 2.5, 6, and 12 months by an independent examiner. In the CPM group, VAS was slightly better at 2.5-month follow-up (7.5 vs. 9.1), but not at the 6-month (0.5 vs. 0.6) or 12-month (0.2 vs. 0.2 – all respectively) evaluation. Use of pain medication was not examined. ROM was significantly better in the group of patients who used CPM at 2.5-month follow-up (e.g., forward flexion of 133.0 vs. 120.7) and 6 months (158.1 vs. 151.7), but not at 12 months (165.2 vs. 158.0 – all respectively).
 
Conclusions. Three small RCTs of CPM post-rotator cuff surgery have been identified in the English language literature. Two of these trials report short-term improvements in ROM for patients undergoing CPM, and one reports a short-term reduction in pain. None of the trials report long-term improvements, nor are there any reported benefits in functional status or quality of life. Therefore, the clinical significance of the short-term improvements reported is uncertain. In addition, there is uncertainty about the optimal physical therapy regimen post-shoulder surgery such that the optimal comparison for CPM is not clear. Larger RCTs with longer follow-up are required to determine whether CPM following rotator cuff surgery results in clinically meaningful improvements in health outcomes.
 
2013 Update
This policy was reviewed with a literature search using the MEDLINE database through August 2013 did not reveal any new literature that would prompt a change in the coverage statement. A retrospective comparative study by Herbold et al. evaluated use of CPM in 61 matched pairs of patients admitted to a rehabilitation hospital (Herbold, 2012). Outcomes following use of CPM were compared with those from a cohort of 61 inpatients who also had poor initial ROM, defined as less than 75 degrees of active knee flexion at the time of admission, and matched for postoperative day at admission, age, length of stay, and Health Insurance Prospective Payment System (HIPPS) code. Use of CPM (2 hours per day) was determined primarily by the referring physician, and was used in 29% of the pool of 633 patients who had poor initial ROM. The average length of stay was 7.85 days. There were no significant differences in outcomes at discharge, including knee flexion or extension, discharge to the community, need for home care services, need for an assistive device, or functional scores on the HIPPS.
 
The policy statement is unchanged.
 
2014 Update
A literature search conducted through August 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below
 
TKA
Early Postoperative Period: Efficacy in the early postoperative period has been cited to support the continued use of these devices in the home setting following early discharge. CPM after TKA was the subject of a 2003 Cochrane review (Milne, 2003). This review reported that CPM combined with physical therapy was found to statistically significantly increase active knee flexion and decrease length of stay. However, the analysis suggests that the benefits of CPM in a hospital setting may be small and only short term. This Cochrane review was updated in 2010 and 2014 (Harvey, 2014). The updated review included  24 randomized trials with 1445 participants and examined short-term (<6 weeks), medium-term (6 weeks-6 months), and long-term (>6 months) effects of CPM. Most of the included studies examined short-term effects. CPM was applied for 1.5 to 24 hours a day, over 1 to 17 days. The review found that there was moderate-quality evidence that CPM increases passive and active knee flexion range of motion (ROM, mean difference, 2 degrees), but the effects were too small to be clinically worthwhile. Low-quality evidence indicated that CPM does not have clinically important short-term effects on pain (-0.4 points on a 10-point scale), and moderate-quality evidence indicated that CPM does not have clinically important medium-term effects on function or quality of life. Very low-quality evidence indicated that CPM may reduce the need for manipulation under anesthesia (25 fewer manipulations per 1000, risk ratio [RR]=0.3), and low-quality evidence suggested that CPM reduced the risk of adverse events (13 fewer adverse events per 1000, RR=0.9). The review concluded that CPM does not have clinically important effects on active knee flexion ROM, pain, function, or quality of life to justify its routine use. It may reduce the risk of manipulation under anesthesia and risk of adverse events, although the quality of evidence supporting these findings was very low and low, respectively.
 
A 2014 study of 150 patients undergoing TKA found no benefit of CPM when used over a 2-day postoperative hospital stay (Boese, 2014).
 
Inpatient Rehabilitation Hospital: In a 2014 randomized trial by Herbold et al, 141 TKA patients were assigned to either 3 hours of CPM daily or to 2 hours total CPM during their inpatient rehabilitation stay (Hervbold, 2014). After an average length of stay of 8 days for both groups, there were no significant differences between the CPM and no CPM groups for active ROM, Timed Up and Go test, knee girth, Functional Independence Measure scores, ambulation device at discharge, or on the self-reported Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
 
Cartilage Repair of the Knee
Karnes et al conducted a 2013 review of CPM protocols following ACI, microfracture, marrow stimulation, mosaicplasty osteochondral autograft or osteochondral allograft (Karnes, 2013). They identified 107 studies that described the use of CPM following cartilage repair surgery. Although reporting of CPM parameters was poor, the most commonly prescribed protocol was for 6 to 8 hours daily over 6 weeks.
 
2015 Update
A literature search conducted through May 2015 did not reveal any new information that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
A 2014 Cochrane review that included 11 randomized controlled trials (RCTs) found no evidence that CPM reduced venous thromboembolism after TKA (He, 2014).
 
Intra-Articular Knee Fractures
Hill and colleagues randomized 40 patients with intra-articular fractures of either the proximal part of the tibia or the distal end of the femur to standardized PT with or without the use of CPM for 48 hours postoperatively (Hill, 2014). At the 48-hour assessment, the CPM group had significantly greater knee flexion (43° difference, p<0.005). However, 6 of 20 patients were unable to tolerate CPM, and there was no benefit to adding 48 hours of CPM when assessed at any of the follow-up visits (2, 6, 12, 24 weeks).
 
2016 Update
A literature search conducted through August 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A systemic review by Howard and colleagues evaluated CPM and other postoperative practices after knee cartilage repair (Howard, 2010). This review cites several basic science studies that appear to support CPM. The authors identified 2 clinical studies, both of which were nonrandomized comparative studies. In 1 study, there were no differences between groups in clinical or functional outcomes at an average follow-up of 4.2 years. In the other study, the CPM group had greater improvement in grading of the cartilage lesion.
 
A randomized trial evaluated a specific CPM device for treatment of chronic low back pain in 36 patients (Gavish, 2015).  Although patients treated with the device appeared to have improved outcomes on a numeric rating scale of back pain compared to waiting-list controls, the study has significant methodologic problems. Patients who received other treatments were excluded, a large number of subjects dropped out, and control patients did not receive any conservative management.
 
American Academy of Orthopaedic Surgeons
The American Academy of Orthopaedic Surgeons (AAOS) published evidence-based guidelines on the surgical management of osteoarthritis of the knee in 2015 (AAOS, 2015). AAOS identified 2 high-quality studies and 5 moderate-quality studies that evaluated the use of CPM. In 1 high-quality study, CPM was used for about 2 weeks after discharge. AAOS concluded that, “the combined results provide strong evidence that the surgical outcomes for those who used continuous passive motion are not better than for those who did not use continuous passive motion.”
 
2017-2019 Update
A literature search conducted using the MEDLINE database did not identify any new literature that would prompt a change in the coverage statement.
 
2017-2019 Update
A literature search was conducted through November 2018.  There was no new information identified that would prompt a change in the coverage statement.  
 
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2020. No new literature was identified that would prompt a change in the coverage statement.
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2021. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2022. No new literature was identified that would prompt a change in the coverage statement.
 
July 2023 Update
Rehabilitation therapy device with Remote Monitoring and Adjustment
No studies have been published which evaluate the effects of any rehabilitation therapy device with remote monitoring or adjustment capabilities on improving health outcomes. No nationally recognized guidelines have been published that recommend the use of such devices for any medical purpose.
 
One clinical trial [NCT04497129 - ROMTECH PortableConnect Rehabilitation Device Usage Post Unilateral Total Knee Arthroplasty (TKA)] has been identified that is currently recruiting participants.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A systematic review of continuous passive motion after knee cartilage defect surgery was published (Fazalare, 2010). Reviewers found that continuous passive motion had been used following autologous chondrocyte implantation, microfracture, and osteochondral autografts in numerous studies in the previous 5 years. Four level III (cohort) studies with 262 patients were identified that compared continuous passive motion with no continuous passive motion; no RCTs were identified. Procedures in these 4 studies included microfracture, periosteal transplant of the patella, and high tibial osteotomy with diagnostic arthroscopy or abrasion arthroplasty. continuous passive motion regimens ranged from range of motion 6 days to 8 weeks. Heterogeneity in the studies and outdated surgical techniques limited conclusions drawn from these trials. Clinical outcomes did not permit a definitive conclusion of efficacy of continuous passive motion. However, reviewers cited several studies in which other outcomes (e.g., histologic outcomes on follow-up biopsies) did favor continuous passive motion.
 
In a systematic review of anterior cruciate ligament reconstruction rehabilitation, it was discussed 6 RCTs on continuous passive motion published before 1996; no RCTs published after the 1997 TEC Assessment were identified (Wright, 2008). Reviewers found no substantial advantage for continuous passive motion use and concluded that continuous passive motion for anterior cruciate ligament rehabilitation could not be justified. It was also noted that most current anterior cruciate ligament rehabilitation protocols initiate early motion within the first postoperative week (Wright, 2008).
A 2022 review was conducted to synthesize evidence from systematic reviews for rehabilitation interventions following anterior cruciate ligament injury (Culvenor, 2022). This review identified 1 systematic review that included evidence for continuous passive motion by (Gatewood, 2017). The authors identified 2 RCTs of continuous passive motion in the immediate postoperative setting, 1 of which was not included in the review by Wright. In this study, 60 patients (95% of whom were men) were randomized to use of a continuous active motion device or continuous passive motion device for 7 days, beginning on postoperative day 1 (Friemert, 2006). No difference was identified between groups in knee range of motion or pain at postoperative day 7. Patients in the continuous active motion group demonstrated a significant improvement in joint position sense (measured by passive angle reproduction) relative to the continuous passive motion group at postoperative day 7, with a between-group difference of 2.2 degrees.
 
One older pilot study (1999) examined the use of continuous passive motion in patients with hip osteoarthritis in the absence of surgical intervention (Simkin, 1999). In this uncontrolled study, continuous passive motion was used for 1.2 to 7.6 hours daily during the 12-week trial. While improvements were noted in patients’ pain assessments, a controlled trial is needed to validate this treatment effect, particularly compared with a program of regular walking.
 
An RCT compared continuous passive motion (n=20) with physical therapy PT (n=21) for the treatment of adhesive capsulitis in patients who had diabetes (Ekim, 2016). Continuous passive motion or physical therapy PT was provided for 1 hour a day (5 d/wk) for 4 weeks. All patients received electrotherapy and after the 4-week initial treatment phase, were instructed to continue with an 8-week at home exercise program. Outcome measures were pain (at rest, in motion, at night) and range of motion (active and passive). Pain decreased significantly in both treatment groups, though patients in the continuous passive motion group reported a larger improvement in pain scores than those in the physical therapy PT group. Range of motion improved significantly in both treatment groups as well. Patients in the continuous passive motion group reported larger improvements in abduction and flexion measures than patients in the continuous passive motion group PT group, while external and internal rotation improvements were similar across groups.
 
A randomized trial was conducted that examined the role of continuous passive motion in patients undergoing silicone interposition arthroplasty of the metacarpophalangeal joints secondary to rheumatoid arthritis (Ring, 1998). Patients were randomized to a 6-week protocol of continuous passive motion (10 hands [40 joints]) or to a standard dynamic splint protocol (15hands [60 joints]). The trial did not show better outcomes in the continuous passive motion group.
 
In 2008, a retrospective chart review compared 15 patients who had received continuous passive motion after tenolysis with 21who did not (Schwartz, 2008). Patients who received continuous passive motion improved total active motion by 40 (range, 137-177), while patients who did not improved total active motion by 32 (range, 152-184); this difference was not statistically significant.
 
One study (2005) has compared continuous passive motion with immobilization following surgical treatment of idiopathic clubfoot in 37 infants (50 feet) (Zeifang, 2005). The infants were randomized to continuous passive motion (4 h/d) or to casting during days 10 to42 following surgery. Blinded analysis showed improvements in the Dimeglio Clubfoot Score with continuous passive motion(range of motion 9.7 to 3.1) that were significantly greater than those in the control group (range of motion 10.3 to 4.2) through12 months (97% follow-up). Between 12 and 18 months, this trend reversed and by 48 months post-surgery, there was no significant difference between groups. Another study (2007) by the same group reported low compliance with this treatment (Kasten, 2007).
 
Continuous passive motion has been studied as a means to aid recovery of motor skills following stroke. One study (2005) randomized 35 patients to daily sessions of use of a shoulder joint continuous passive motion device (25 minutes) or to daily group therapy sessions consisting of self-directed shoulder range of motion for poststroke rehabilitation (Lynch, 2005). All patients also received standard poststroke therapy for 3.5 hours a day. After 20 days of therapy, there was a trend for greater shoulder joint stability in the continuous passive motion group (n=17, p=0.06) compared with the control group (n=15). No statistically significant differences were found for measures of motor impairment. This trial had a small sample size and short follow-up period, suggesting it may have had inadequate power to detect important differences in key outcomes.
 
In a 2022 randomized, single-blind crossover study, 18 patients aged 20 to 79 years with mild to severe arm-hand impairment following unilateral stroke were assigned (at least 6 months post-stroke) to undergo home-based therapy sessions twice daily, 5days per week for 4 weeks, consisting of either task-specific motor training with an occupational therapist or home-based therapy with a robotic exoskeleton system combining continuous passive motion and robot-assisted gripping exercises (Kuo, 2022). All patients received standard-of-care occupational therapy and physical therapy (PT) for 2 hours per week. Crossover occurred following a12-week washout. Patients initially assigned to the robotic exoskeleton intervention followed by task-specific motor training experienced significantly greater improvement in wrist extension range of motion at the end of treatment compared to those who received interventions in the opposite order. Assessments of manual dexterity and motor performance of the upper extremity were significantly improved following exoskeleton therapy, whereas no significant differences in these measures were noted following task-specific motor training. A significantly greater proportion of patients reported improvements in global symptoms after exoskeleton therapy (77%) than after task-specific motor training (11%).
 
In 2020, the American Physical Therapy Association (APTA) published a clinical practice guideline on physical therapists’ management of patients undergoing total knee arthroplasty (Jette, 2020). The APTA identified 4 high-quality studies, 6 moderate-quality studies, and 2 low-quality studies evaluating the effect of continuous passive motion devices on knee flexion and extension range of motion and need for manipulation under anesthesia, with moderate-quality studies indicating benefit with continuous passive motion contradicted by high-quality studies indicating no significant difference. Meta-analyses did not indicate a significant impact of continuous passive motion on function or hospital length of stay. The APTA concluded that "physical therapists should NOT use CPMs [continuous passive motion devices] for patients who have undergone primary, uncomplicated TKA [total knee arthroplasty]."
 
In 2005, the Centers for Medicare & Medicaid Services issued a national coverage determination on durable medical equipment reference, which stated:
 
“Continuous passive motion devices are devices covered for patients who have received a total knee replacement. To qualify for coverage, use of the device must commence within 2 days following surgery. In addition, coverage is limited to that portion of the3-week period following surgery during which the device is used in the patient's home. There is insufficient evidence to justify coverage of these devices for longer periods of time or for other applications.” (Center for Medicare & Medicaid, 2005)
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through March  2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A a systematic review was conducted of continuous passive motion compared to PT in patients with primary adhesive capsulitis (Baradaran, 2023). A total of 5 studies were included in the meta-analysis, but the conclusions were limited by heterogeneity. The authors concluded that continuous passive motion may be slightly effective in the short-term, but that long-term efficacy is still unknown.
 
The results of a randomized trial were reported that compared continuous passive motion to PT in patients who underwent retrograde femoral nailing for femoral fracture (Olasinde, 2023). The 88 participants were randomized to continuous passive motion or conventional PT, each for 2 hours daily. Knee stiffness at weeks 1, 2, and 6 were significantly lower among patients who received continuous passive motion compared to patients who received conventional PT (all p<.0001). Pain scores (measured by visual analogue scale) were significantly lower for the first 7 days in the continuous passive motion group, and total arc of motion gained postoperatively was also significantly larger at postoperative weeks 1, 2, and 6 (all p<.05). Interpretation of these results is limited because the duration of the intervention was not clearly stated.

CPT/HCPCS:
E0935Continuous passive motion exercise device for use on knee only
E0936Continuous passive motion exercise device for use other than knee
E1399Durable medical equipment, miscellaneous

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