Use of Continuous Passive Motion Devices meets primary coverage criteria that there be scientific evidence of effectiveness for:

 

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.)

 

 

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.

 

 

 

Use of Continuous Passive Motion Devices meets primary coverage criteria that there be scientific evidence of effectiveness for:

 

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.)

 

 

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.

 

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:

 

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.

 

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.

 

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.

 

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.

 

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.

 

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.

 

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.

 

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.

 

A search of the literature from 2003 through January 2006 did not identify any additional published clinical trials.

 

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.

 

 

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 (4–10 months) or final (10–56 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).