Description
Continuous passive motion (CPM) devices are used to keep a joint in motion without patient assistance. CPM is being evaluated for treatment and postsurgical rehabilitation of the upper- and lower-limb joints and for a variety of musculoskeletal conditions.

For individuals who have total knee arthroplasty (TKA) who receive CPM in the home setting, the evidence includes randomized controlled trials (RCTs), case series, and systematic reviews. The relevant outcomes are symptoms and functional outcomes. Early trials generally used CPM in the inpatient setting and are less relevant to today’s practice patterns of short hospital stays followed by outpatient rehabilitation. Current postoperative rehabilitation protocols differ considerably from when the largest body of evidence was collected, making it difficult to apply available evidence to the present situation. For use of CPM after TKA, recent studies have suggested that institutional and home use of CPM has no benefit compared with standard physical therapy (PT). There were no studies evaluating CPM in patients who could not perform standard PT. The evidence is insufficient to determine the effects of the technology on health outcomes.

For patients unable to tolerate exercise regimens following TKA, CPM is an alternative modality. However, there is no evidence to support its use in this situation. Clinical input obtained in 2010 supports the use of CPM under conditions of low postoperative mobility or inability to comply with rehabilitation exercises following a TKA or TKA revision.

For individuals who have articular cartilage repair of the knee who receive CPM in the home setting, the evidence includes nonrandomized studies, case series, and studies with nonclinical outcomes (e.g., histology), and systematic reviews of these studies. The relevant outcomes are symptoms and functional outcomes. Systematic reviews of CPM for this indication have cited studies reporting better histologic outcomes in patients following CPM. A few studies have reported clinical outcomes but inadequacies of these studies do not permit conclusions on efficacy. The evidence is insufficient to determine the effects of the technology on health outcomes.

Despite a lack of published evidence, clinical input obtained in 2016 supports the use of CPM after articular cartilage repair of the knee.

For individuals who have musculoskeletal conditions other than TKA or knee cartilage repair requiring PT who receive CPM in the home setting, the evidence includes RCTs for some conditions and case series for others. The relevant outcomes are symptoms and functional outcomes. Three small RCTs of CPM after rotator cuff surgery showed some evidence that CPM after this shoulder surgery improved short-term pain and range of motion; however, the trials were not high-quality, and the small differences in outcomes may not be clinically important. Two trials reported short-term improvements in range of motion for patients undergoing CPM, and one reported a short-term reduction in pain. None reported long-term improvements, and there are no reported benefits in functional status. Therefore, the clinical significance of the short-term improvements reported is uncertain. In addition, there is uncertainty about the optimal PT regimen following shoulder surgery such that the optimal treatment comparator for CPM is unclear. Two small RCTs compared CPM with conventional PT for treatment of adhesive capsulitis. One of the trials focused on diabetic patients with adhesive capsulitis. Both reported comparable improvements in range of motion and functional ability between treatment groups. For other musculoskeletal conditions, RCTs do not exist; case series either did not show efficacy of CPM or had important methodologic flaws. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have had a stroke requiring PT who receive CPM in the home setting, the evidence includes a small RCT. The relevant outcomes are symptoms and functional outcomes. This trial reported a trend toward improved shoulder joint stability but no statistical difference between CPM plus PT and PT alone. The trial was small and treatment lasted only 20 days. The evidence is insufficient to determine the effects of the technology on health outcomes. 

Background 
Physical therapy (PT) of joints following surgery focuses both on passive motion to restore mobility and on active exercises to restore strength. While passive motion can be administered by a therapist, continuous passive motion (CPM) devices have also been used. CPM is thought to improve recovery by stimulating the healing of articular tissues and the circulation of synovial fluid; reducing local edema; and preventing adhesions, joint stiffness or contractures, or cartilage degeneration. CPM has been investigated primarily in the knee, particularly after total knee arthroplasty or ligamentous or cartilage repair. Acceptance of its use in the knee joint has created interest in CPM use for other weight-bearing joints (i.e., hip, ankle, metatarsals) as well as non-weight-bearing joints (i.e., shoulder, elbow, metacarpals, interphalangeal joints). Use of CPM in stroke and burn patients is also being explored.

The device used for the knee moves the joint (e.g., flexion and extension) without patient assistance, continuously for extended periods of time (i.e., up to 24 h/d). 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 assessed intraoperatively. The ROM is increased by 3° to 5° per day, as rated. The speed and ROM can be varied, depending on joint stability. The use of the device 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. 

Policy
Use of continuous passive motion (CPM) in the home setting may be considered MEDICALLY NECESSARY as an adjunct to physical therapy in the following situations:

• Under conditions of low postoperative mobility or inability to comply with rehabilitation exercises following a total knee arthroplasty (TKA) or TKA revision. This may include patients with complex regional pain syndrome (reflex sympathetic dystrophy); extensive arthrofibrosis or tendon fibrosis; or physical, mental, or behavioral inability to participate in active physical therapy.
• During the non-weight-bearing rehabilitation period following 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 CPM in the home setting for all other conditions is considered NOT MEDICALLY NECESSARY.

Policy Guidelines
Following total knee arthroplasty (TKA), continuous passive motion (CPM) in the home setting will be allowable for up to 17 days after surgery while patients are immobile or unable to bear weight.

Following intra-articular cartilage repair procedures of the knee, CPM in the home setting will be allowable for up to 6 weeks during non-weight-bearing rehabilitation.

Benefit Application
BlueCard/National Account Issues
When offered in the home setting, CPM may be adjudicated under durable medical equipment (DME) benefits. In other settings, CPM may be adjudicated as a form of physical therapy.

State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity.

Rationale
Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., people of color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (lesbian, gay, bisexual, transgender, queer, intersex, asexual); women; and people with disabilities [physical and invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Total Knee Arthroplasty
Clinical Context and Therapy Purpose
The purpose of continuous passive motion in the home setting in patients with total knee arthroplasty is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review:

Populations
The relevant population of interest is patients with total knee arthroplasty.

Interventions
The therapy being considered is continuous passive motion.

Comparators
The following therapies are currently being used for total knee arthroplasty: Physical therapy alone or standard of care, if unable to tolerate physical therapy.

Outcomes
The general outcomes of interest are symptoms and functional outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Early Postoperative In-Hospital Setting
Review of Evidence
Systematic Reviews
This evidence review was informed by a TEC Assessment (1997) that concluded continuous passive motion met the TEC criteria as an adjunct to physical therapy (PT) in patients undergoing total knee arthroplasty.³ Early studies of continuous passive motion machines focused on their use in the hospital setting, in which the impact on length of stay was frequently considered a key clinical outcome, and so the TEC Assessment did not specifically examine the point of service or the length of time continuous passive motion devices were used. A critical study identified in the TEC Assessment was an RCT by McInnes et al. (1992) that compared use of continuous passive motion initiated in the immediate postoperative period and continued through the 7-day hospital stay with standard rehabilitation alone.⁴ At 6 weeks postoperatively, the most salient difference between groups was an increased incidence of arthrofibrosis requiring manipulation in the non-continuous passive motion group.

Efficacy in the early postoperative period has been cited as a reason to support the continued use of these devices in the non-acute care hospital or home setting following early discharge. continuous passive motion after total knee arthroplasty was the subject of a 2003 Cochrane review.⁵ Reviewers reported that continuous passive motion combined with PT significantly increased active knee flexion and decreased length of stay. However, the analysis suggested the benefits of continuous passive motion in a hospital setting may be small and only short-term.⁶ This Cochrane review was updated in 2010 and again in 2014.^7,8 The updated review included 24 RCTs with 1,445 participants and examined short-term (< 6 weeks), medium-term (6 weeks to 6 months), and long-term (> 6 months) effects of continuous passive motion. Most selected studies examined short-term effects. Continuous passive motion was applied for 1.5 to 24 hours a day, over 1 to 17 days. A summary of findings is provided in Table 1.

Table 1. 2014 Cochrane Review Findings on Continuous Passive Motion

Findings	QOE
continuous passive motion increases passive and active knee flexion range of motion (mean difference, 2), but the effects were too small to be clinically relevant	Moderate
continuous passive motion does not have clinically important short-term effects on pain (-0.4 points on a 10-point scale)	Low
continuous passive motion does not have clinically important medium-term effects on function or quality of life	Moderate
continuous passive motion may reduce the need for manipulation under anesthesia (25 fewer manipulations per 1,000; RR = 0.3)	Very low
continuous passive motion reduced the risk of adverse events (13 fewer adverse events per 1000, RR = 0.9)	Low

Adapted from Harvey et al. (2014).7, QOE: quality of evidence; RR: relative risk.
Another 2014 Cochrane systematic review, which included 11 RCTs, found no evidence that continuous passive motion reduced venous thromboembolism after total knee arthroplasty.⁹

Randomized Controlled Trials
Yashar et al. (1997) randomized 178 patients undergoing total knee arthroplasty to continuous passive motion immediately post-surgery or to continuous passive motion 1 day post-surgery.¹⁰ A small but statistically significant improvement in flexion was found at the time of discharge among those started on immediate continuous passive motion, but this difference did not persist at 4 weeks. MacDonald et al. (2000) reported on a randomized trial comparing immediate postoperative continuous passive motion with no continuous passive motion for 120 patients after total knee arthroplasty.¹¹ Patients received a maximum of 24 hours with continuous passive motion. There were no differences between treatment groups in range of motion, length of stay, or analgesic requirements. In a trial reported by Pope et al. (1997), 53 patients were randomized to 1 of 2 schedules of continuous passive motion (both for 48 hours) or to no continuous passive motion.¹² The use of continuous passive motion was not associated with improved long-term function or range of motion. Kumar et al. (1996) randomized 73 patients who had undergone total knee arthroplasty to continuous passive motion immediately postsurgery or to a protocol of early passive flexion, referred to as the “drop and dangle” technique.¹³ Patients assigned to passive flexion were discharged from the hospital one day earlier and also had a statistically better extension range of 2.8 at 6 months than the continuous passive motion group.

Other RCTs have found that 2 to 4 hours of daily continuous passive motion in the hospital after total knee arthroplasty did not improve postoperative outcomes at discharge or follow-up.^14,15,16,17 In one trial, Bruun-Olsen et al. (2009) randomized 63 patients undergoing total knee arthroplasty to active PT exercises with or without continuous passive motion to assess any short-term benefit on pain or function.¹⁴ In both groups, exercises were performed daily for 30 minutes, starting 1 day after surgery and continuing until discharge at 1 week. For the experimental group, continuous passive motion was administered for 4 hours on the day of surgery, followed by 6 hours daily in addition to therapist-guided exercises. Blinded assessments at 1 week and 3 months after surgery showed similar results for pain and function in the 2 groups. At 1 week, both groups had visual analog scale pain ratings of 40 and flexion scores within 2 of each other. Functional testing at 3 months showed no benefit of adjunctive continuous passive motion. The lack of improvement with continuous passive motion in these studies might have been attributable to patients mobilizing or commencing flexion immediately following surgery.¹⁶ A 2014 study of 150 patients undergoing total knee arthroplasty found no benefit of continuous passive motion when used over a 2-day postoperative hospital stay.¹⁷

Non-Acute Care Hospital Setting
In a RCT, Herbold et al. (2014) assessed 141 total knee arthroplasty patients assigned to daily conventional therapy lasting 3 hours or daily continuous passive motion for 2 hours throughout their inpatient rehabilitation stay.¹⁸ After an average length of stay of 8 days, there were no significant differences between the continuous passive motion and no continuous passive motion groups for active range of motion, 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 scores.

In 2000, Chen et al. (2000) randomized 51 patients in an inpatient rehabilitation service who had undergone total knee arthroplasty to conventional active PT or to PT plus continuous passive motion.¹⁹ Referral to the rehabilitation center was made 5 to 6 days after surgery, and most had received continuous passive motion as part of the initial hospitalization. Knee flexion was the principal outcome. No significant differences were noted in passive range of motion between the 2 groups, as measured on admission, on the third and seventh days, and at the time of discharge (8 days postadmission). Thus, the use of continuous passive motion in the rehabilitation hospital offered no added benefit.

In a 2012 retrospective comparative study, the same group as the Herbold et al. RCT evaluated the use of continuous passive motion in 61 matched pairs of patients admitted to a rehabilitation hospital.²⁰ Outcomes following use of continuous passive motion were compared with those from a cohort of 61 inpatients who also had poor initial range of motion, defined as less than 75 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 code. Use of continuous passive motion (2 h/d) was determined primarily by the referring physician and used in 29% of the pool of 633 patients who had poor initial range of motion. 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 Health Insurance Prospective Payment System.

Home Setting
A study by Worland et al. (1998) compared the use of continuous passive motion with active PT in the home setting. At discharge, they randomized 80 patients undergoing total knee arthroplasty to home continuous passive motion (3 h/d for 10 days) or to active PT.²¹ Most studies have examined continuous passive motion as an adjunct to active PT, while this study proposed continuous passive motion as an alternative to PT. At 2 weeks, knee flexion was similar in both groups but a flexion contracture was noted in 1 patient in the continuous passive motion group. At 6 months, no differences were found in knee scores or knee flexion.

In another RCT, Lenssen et al. (2008) evaluated 60 patients with limited flexion range of motion (< 80) at the time of hospital discharge who were assigned to standard PT alone or PT plus continuous passive motion in the home (4 h/d) until assessment on postoperative day 17.²² Blinded assessment showed a trend for increased range of motion for the continuous passive motion group (e.g., 89 vs 84, respectively, p = 0.07), with no differences in function between groups, as measured by the Knee Society Score (function subscore 43 vs 40, respectively) and the Western Ontario and McMaster Universities Osteoarthritis Index difficulty score (49 vs 45, respectively). No differences were observed between groups in range of motion or function at the 6-week or 3-month assessment. In addition, no differences were observed for the secondary outcome measures (perceived effect, medication use, satisfaction with treatment, adherence) at either of the assessment times.

Section Summary: Total Knee Arthroplasty
Numerous RCTs have compared continuous passive motion as adjunctive therapy with PT for patients undergoing total knee arthroplasty. Most trials used continuous passive motion in the inpatient setting and are less relevant to today’s practice patterns of shorter hospital stays followed by outpatient rehabilitation. Some of these trials reported improvements in range of motion for patients receiving continuous passive motion but these improvements were short-term, of small magnitude, and of uncertain clinical significance. The RCTs that specifically evaluated continuous passive motion in the non-acute care hospital setting or home setting did not show improved outcomes with continuous passive motion.

Articular Cartilage Repair of the Knee
Clinical Context and Therapy Purpose
The purpose of continuous passive motion in the home setting in patients with articular cartilage repair of the knee is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review:

Populations
The relevant population of interest is patients with articular cartilage repair of the knee.

Interventions
The therapy being considered is continuous passive motion.

Comparators
The following therapies are currently being used for articular cartilage repair of the knee: standard of care.

Outcomes
The general outcomes of interest are symptoms and functional outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Although no RCTs were identified comparing health outcomes with or without the use of continuous passive motion, continuous passive motion is routinely used as part of the rehabilitation protocol for as long as 6 weeks when weight-bearing is restricted following autologous chondrocyte implantation.^23,24,25 Basic research supports the use of continuous passive motion to facilitate greater healing of articular cartilage of full-thickness defects that penetrate the subchondral bone compared with either immobilization or intermittent mobilization.^26,27

Fazalare et al. (2010) published a systematic review of continuous passive motion after knee cartilage defect surgery.²⁸ 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 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 (eg, histologic outcomes on follow-up biopsies) did favor continuous passive motion.

Another systematic review by Howard et al. (2010) evaluated continuous passive motion and other postoperative practices after knee cartilage repair.²⁹ Reviewers cited several basic science studies using animal models that appear to support continuous passive motion. They identified 2 clinical studies, both of which were retrospective nonrandomized comparative studies. In 1 study (N = 43), there were no differences between groups in clinical or functional outcomes at an average follow-up of 4.2 years. In the other study (N = 77), patients in the continuous passive motion group (n = 46) had greater improvement in grading of the cartilage lesion compared with patients who did not have access to continuous passive motion (n = 31).

Section Summary: Articular Cartilage Repair of the Knee
Current evidence on use of continuous passive motion to facilitate knee rehabilitation after articular cartilage repair includes systematic reviews. These reviews reported methodologic issues with available cohort studies and a paucity of studies assessing clinical application of continuous passive motion to knee rehabilitation.

Other Musculoskeletal Conditions Requiring Physical Therapy
Clinical Context and Therapy Purpose
The purpose of continuous passive motion in the home setting in patients with musculoskeletal conditions other than total knee arthroplasty or knee cartilage repair requiring physical therapy is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of continuous passive motion improve the net health outcome in patients with musculoskeletal conditions other than total knee arthroplasty or knee cartilage repair requiring physical therapy?

The following PICO was used to select literature to inform this review:

Populations
The relevant population of interest is patients with musculoskeletal conditions other than total knee arthroplasty or knee cartilage repair requiring physical therapy.

Interventions
The therapy being considered is continuous passive motion.

Comparators
The following therapies are currently being used for musculoskeletal conditions other than total knee arthroplasty or knee cartilage repair requiring physical therapy: standard of care.

Outcomes
The general outcomes of interest are symptoms and functional outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Articular Knee Fractures
Hill et al. (2014) randomized 40 patients with articular fractures of either the proximal part of the tibia or the distal end of the femur to standardized physical therapy (PT) with or without continuous passive motion for 48 hours postoperatively.³⁰ At the 48-hour assessment, the continuous passive motion group had significantly greater knee flexion (43 difference, p < 0.005). However, 6 of 20 patients were unable to tolerate continuous passive motion and there was no benefit to adding 48 hours of continuous passive motion when assessed at any of the follow-up visits (2, 6, 12, 24 weeks).

Anterior Cruciate Ligament Repair
This literature review did not identify any RCTs of continuous passive motion in the home setting after repair of the anterior cruciate ligament. However, the studies of continuous passive motion after anterior cruciate ligament repair in the immediate postoperative period may be relevant to the non-acute care hospital or home setting for patients discharged following a shorter hospital stay. The TEC Assessment (1997) concluded that continuous passive motion as an adjunct to conventional PT in the immediate postoperative period after anterior cruciate ligament repair offered no demonstrable advantage over conventional PT alone.³ In a systematic review of anterior cruciate ligament reconstruction rehabilitation, Wright et al. (2008) discussed 6 RCTs on continuous passive motion published before 1996; no RCTs published after the 1997 TEC Assessment were identified.³¹ 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. Wright et al. (2008) also noted that most current anterior cruciate ligament rehabilitation protocols initiate early motion within the first postoperative week.

A 2022 review was conducted to synthesize evidence from systematic reviews for rehabilitation interventions following anterior cruciate ligament injury.³² This review identified 1 systematic review that included evidence for continuous passive motion by Gatewood et al. (2017).³³ 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 et al. (2008). 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 1.³⁴ 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.

Rotator Cuff Repair
Du Plessis et al. (2011) published a systematic review of continuous passive motion following rotator cuff repair.³⁵ Three RCTs were included, though meta-analysis could not be conducted due to heterogeneity across trials. Two of the RCTs, by Lastayo et al. (1998) and Raab et al. (1996) are discussed below.^36,37 The third trial was a German-language report by Michael et al. (2005) that found a significant reduction of 12 days in the time to reach 90 abduction compared with the PT control group, with no significant difference in pain between the 2 groups.³⁸

The trial by Lastayo et al. (1998) randomized 31 patients undergoing rotator cuff repair to a 4-week home program of continuous passive motion (average, 3 h/d) or to manual passive elevation and rotation exercises.³⁶ No significant difference in outcomes was observed between the two approaches. Previously, Raab et al. (1996) had randomized 26 patients to postoperative PT alone or to PT plus continuous passive motion.³⁷ Patients were evaluated with preoperative and 3 month postoperative shoulder scores that included pain, function, muscle strength, and range of motion. A statistically significant improvement was found in range of motion for those receiving continuous passive motion, although there was no significant improvement in overall shoulder score between groups. Both of these RCTs were likely under powered to show differences on important clinical outcomes.

Garofalo et al. (2010) reported on a randomized trial assessing the effects of continuous passive motion after rotator cuff repair.³⁹ During weeks 1 to 4 post surgery, all 100 patients underwent passive self-assisted range of motion exercise, with half of the patients also receiving continuous passive motion for 4, 30-minute sessions per day. The physical therapist-supervised exercises included pendulum movements and progressive passive abduction, forward flexion, and external rotation. When patients were not exercising, the shoulder was immobilized in a sling brace. From weeks 5 to 28 post surgery, all patients underwent the same PT protocol. From and visual analog scale ratings for pain were measured at 2.5, 6, and 12 months by an independent examiner. Between groups, visual analog scale ratings were slightly better for patients who received continuous passive motion 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) assessments, all respectively. Range of motion was significantly better in the group receiving continuous passive motion versus those who did not at 2.5-month follow-up (eg, forward flexion, 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.

Subsection Summary: Rotator Cuff Repair
Three RCTs of continuous passive motion following rotator cuff surgery were identified in the English-language literature. Two of these trials reported short-term improvements in range of motion for patients undergoing continuous passive motion, and one reported a short-term reduction in pain. None reported long-term improvements or benefits in functional status. Therefore, the clinical significance of the short-term improvements reported is uncertain. In addition, there is uncertainty about the optimal PT regimen after shoulder surgery, and so the optimal comparator for continuous passive motion is not clear.

Hip Osteoarthritis
One older pilot study (1999) examined the use of continuous passive motion in patients with hip osteoarthritis in the absence of surgical intervention.⁴⁰ 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.

Adhesive Capsulitis of the Shoulder
Dundar et al. (2009) compared continuous passive motion with PT in a randomized trial of 57 patients with adhesive capsulitis (frozen shoulder).⁴¹ Continuous passive motion or PT was provided for 1 hour a day (5 d/wk) for 4 weeks. Pain and function levels were similar in the 2 groups at baseline, with visual analog scale scores for pain ranging from 5.44 (at rest) to 6.34 (with movement). Assessments at baseline, 4, and 12 weeks showed reductions in pain and improvements in function levels for both groups. However, continuous passive motion resulted in greater pain reduction than PT (at rest, 47% vs 25%; with movement, 35% vs 21%; at night, 36% vs 19%, all respectively). There were no differences between groups in range of motion or function. This trial provided modest support for the inclusion of continuous passive motion in a PT regimen for this patient population.

An RCT by Ekim et al. (2016) compared continuous passive motion (n = 20) with PT (n = 21) for the treatment of adhesive capsulitis in patients who had diabetes.⁴² Continuous passive motion or 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 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 PT group, while external and internal rotation improvements were similar across groups.

Elbow Contracture
Postoperative management of open elbow contracture release with continuous passive motion was assessed in a matched cohort study by Lindenhovius et al. (2009).⁴³ Sixteen patients who had used continuous passive motion after open contracture release and 16 patients who had not were matched by age, sex, diagnosis, range of motion, and radiographic appearance. Improvements in range of motion did not differ between groups at the early (range, 4 – 10 months) and the final (range, 11 – 56 months) evaluations.

Hand Repair
In 1997, the TEC Assessment reviewed a multicenter study of continuous passive motion in patients who had undergone flexor tendon repair, and found the data inadequate to permit scientific conclusions about continuous passive motion application.³

Ring et al. (1998) conducted a randomized trial that examined the role of continuous passive motion in patients undergoing silicone interposition arthroplasty of the metacarpophalangeal joints secondary to rheumatoid arthritis.⁴⁴ Patients were randomized to a 6-week protocol of continuous passive motion (10 hands [40 joints]) or to a standard dynamic splint protocol (15 hands [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 21 who did not.⁴⁵ 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.

Foot Repair
One study (2005) has compared continuous passive motion with immobilization following surgical treatment of idiopathic club foot in 37 infants (50 feet).⁴⁶ The infants were randomized to continuous passive motion (4 h/d) or to casting during days 10 to 42 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) through 12 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.⁴⁷

Back Pain
An RCT by Gavish et al. (2015) evaluated a continuous passive motion device for treatment of chronic low back pain in 36 patients.⁴⁸ Although patients treated with the device appeared to have improved outcomes on a numeric rating scale of back pain compared with waiting-list controls, the trial had 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.

Section Summary: Other Musculoskeletal Conditions Requiring Physical Therapy
There is a wide range of studies assessing the use of continuous passive motion for musculoskeletal conditions other than total knee arthroplasty and knee cartilage repair. No RCTs of continuous passive motion conducted in the home setting after anterior cruciate ligament repair were identified; RCTs conducted in the immediate postoperative setting do not indicate clinical benefit with use of continuous passive motion compared to conventional PT. Three small RCTs of continuous passive motion after rotator cuff surgery showed some evidence that continuous passive motion after this shoulder surgery improved short-term pain and range of motion; however, the trials were not high-quality, and the small differences in outcomes may not be clinically important. Two trials reported short-term improvements in range of motion for patients undergoing continuous passive motion, and one reported a short-term reduction in pain. None reported long-term improvements, and there are no reported benefits in functional status. Therefore, the clinical significance of the short-term improvements reported is uncertain. In addition, there is uncertainty about the optimal PT regimen following shoulder surgery such that the optimal treatment comparator for continuous passive motion is unclear. Two small RCTs compared continuous passive motion with conventional PT for treatment of adhesive capsulitis. One of the trials focused on diabetic patients with adhesive capsulitis. Both reported comparable improvements in range of motion and functional ability between treatment groups. For other musculoskeletal conditions, RCTs do not exist; case series either did not show efficacy of continuous passive motion or had important methodologic flaws.

Stroke
Clinical Context and Therapy Purpose
The purpose of continuous passive motion in the home setting in patients with stroke is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review:

Populations
The relevant population of interest is patients with stroke.

Interventions
The therapy being considered is continuous passive motion.

Comparators
The following therapies are currently being used for stroke: standard of care.

Outcomes
The general outcomes of interest are symptoms and functional outcomes.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Consistent with a "best available evidence approach," within each category of study design, studies with larger sample sizes and longer durations were sought.
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
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 post-stroke rehabilitation.⁴⁹ All patients also received standard post-stroke 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, 5 days 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.⁵⁰ All patients received standard-of-care occupational therapy and physical therapy (PT) for 2 hours per week. Crossover occurred following a 12-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%).

Section Summary: Stroke
Two small randomized trials have reported mixed results with different continuous passive motion devices in combination with PT or occupational therapy compared to PT or occupational therapy alone in patients who have experienced stroke, including a statistically non-significant trend toward improvement for the outcome of shoulder joint stability and significant improvements in wrist extension range of motion, manual dexterity, and global symptoms related to upper extremity movement. Both trials were small and treatment lasted only 20 days in the shoulder joint study by Lynch et al.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Clinical Input Range of Motion Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2016 Input
In response to requests, input was received from 2 physician specialty societies and 1 academic medical center while this policy was under review in 2016. Input considered continuous passive motion (continuous passive motion) medically necessary as an adjunct to physical therapy during the non-weight-bearing rehabilitation period following articular cartilage repair procedures of the knee. One reviewer referred to the American Academy of Orthopaedic Surgery (2015) guidelines on the surgical management of osteoarthritis of the knee, which concluded that there was strong evidence that continuous passive motion after knee arthroplasty does not improve outcomes.

2010 Input
In response to requests, input was received from 2 physician specialty societies and 5 academic medical centers while this policy was under review in 2010. Overall, input supported the use of continuous passive motion under conditions of low postoperative mobility or inability to comply with rehabilitation exercises after total knee arthroplasty or total knee arthroplasty revision or during the non-weight-bearing rehabilitation period following articular cartilage repair procedures of the knee. Support was limited for use of continuous passive motion in joints other than the knee or in situations or conditions other than those described in this evidence review.

2008 Input
In response to requests, input was received from 1 physician specialty society and 2 academic medical centers while this policy was under review in 2008. The 3 reviewers interpreted the existing literature as supporting the use of continuous passive motion for the knee for at least 7 days post operatively, whether in the hospital or home, and suggested that longer use of continuous passive motion would be warranted for special conditions.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in Supplemental Information if they were issued by, or jointly by, a U.S. professional society, an international society with U.S. representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Physical Therapy Association
In 2020, the American Physical Therapy Association (APTA) published a clinical practice guideline on physical therapists' management of patients undergoing total knee arthroplasty.⁵¹ 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]."

American Academy of Orthopaedic Surgeons
In 2015, the American Academy of Orthopaedic Surgeons (AAOS) published evidence-based guidelines on the surgical management of osteoarthritis of the knee.⁵² The AAOS identified 2 high-quality studies and 5 moderate-quality studies that evaluated the use of continuous passive motion. In one high-quality study, continuous passive motion was used for about 2 weeks after discharge. The 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.” The 2022 update to the AAOS guidelines, which replaces the 2015 version, does not address use of continuous passive motion.⁵³

U.S. Preventive Services Task Force Recommendations
Not applicable

Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 2.

Table 2. Summary of Key Trials

NCT No.	Trial Name	Planned Enrollment	Completion Date
Ongoing
NCT05226988	Effect of Hybrid Robot-assisted Training Using End-effector and Exoskeleton Devices in Distal Upper Extremity After Stroke: Motor Control, Motor and Daily Function, Quality of Life	70	Oct 2025
Unpublished
NCT01420887	Preservation of Joint Function Using Postoperative Continuous Passive Motion (continuous passive motion): A Pilot Study	60	May 2020

NCT: national clinical trial.

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26. Nugent-Derfus GE, Takara T, O'neill JK, et al. Continuous passive motion applied to whole joints stimulates chondrocyte biosynthesis of PRG4. Osteoarthritis Cartilage. May 2007; 15(5): 566-74. PMID 17157538
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54. Center for Medicare & Medicaid. National Coverage Decision (NCD) for Durable Medical Equipment Reference List (280.1). 2005; https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=190&bc=AgAAQAAAAAAA&ncdver=2. Accessed February 11, 2023.

Coding Section

Codes	Number	Description
CPT		No Appliciable codes
ICD-9 Diagnosis	337.22	Reflex sympathetic dystrophy of the lower limb
	715.16	Osteoarthrosis, loclized, primary; lower leg
	715.26	Osteoarthrosis, loclized, secondary, lower leg
	715.36	Osteoarthrosis, loclized, not specified whether primary or secondary, lower leg
	715.96	Osteoarthrosis, unspecified whether generalized or localized, lower leg
	716.16	Traumatic arthropathy, lower leg
	717.83	Old disruption anterior cruciate ligament
	718.06	Articular cartilage disorder, lower leg
	718.56	Ankylosis of joint, lower leg (includes arthrofibrosis of knee)
	718.86	Other joint derangement, lower leg
	719.86	Other specified disorders of joint, lower leg
	732.7	Osteochondritis dissecans
	821.20-821.39	Fracture of lower end of femur, code range
	822.0-822.1	Fracture of patella, code range
	823.00, 823.10	Fracture of upper end of tibia, code list
	959.7	Injury, other and unspecified, knee, leg, ankle, and foot
	V43.65	Organ or tissue replaced by other means, joint, knee
	V54.81	Aftercare following joint replacement
HCPCS	E0935	Continuous passive motion exercise device for use on knee only
	E0936	Continuous passive motion exercise device for use other than knee
	E1399	Durable medical equipment, miscellaneous
ICD-10-CM (effective 10/01/15)	G57.70-G57.72	Causalgia of lower limb (Includes complex regional pain syndrome ll of lower limb)
	G90.521-G90.529	Complex regional pain syndrome l of lower limb, code range
	M12.561-M12.569	Traumatic arthropathy, knee, code range
	M17.0-M17.9	Osteoarthritis of knee, code range
	M23.50-M23.52	Chronic instability of knee, code range
	M23.8x1-M23.92	Other and unspecified internal derangement of knee, code range
	M24.661-M24.669	Ankylosis, knee, code range
	M93.261-M93.269	Osteochondritis dissecans, knee, code range
	S72.401A-S72.499S	Fracture of lower end of femur, code range
	S82.001A-S82.099S	Fracture of patella, code range (7th characters C, F, J, N, or R do not apply in this code range)
	S82.101A-S82.199S	Fracture of upper end of tibia, code range
	S89.90xA-S89.92xS	Unspecified injury of lower leg, code range
	Z47.1	Aftercare following joint replacement surgery (used with code from 96.6xx to indentify joint)
	Z96.651-Z96.659	Presence of artificial knee joint, code range
ICD-10-PCS (effective 10/01/15)		Not applicable. Policy is only for outpatient services.
Type of Service	Durable Medical Equipment
Place of Service	Outpatient

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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