Continuous Passive Motion (CPM) Machines

Number: 0010

  1. Aetna considers continuous passive motion (CPM) machines medically necessary durable medical equipment (DME) to improve range of motion in any of the following circumstances:

    1. During the post-operative rehabilitation period for members who have received a total knee arthroplasty or replacement as an adjunct to on-going physical therapy (PT); or
    2. Members who have had an anterior cruciate ligament repair until the member is participating in an active PT program; or  
    3. Members undergoing surgical release of arthrofibrosis/adhesive capsulitis or manipulation under anesthesia of any joint (knee, shoulder, and elbow the commonest) until the member is participating in an active PT program; or   
    4. To promote cartilage growth and enhance cartilage healing during the non weight-bearing period following any of the following until the member begins the weight-bearing phase of recovery:
      1. After abrasion arthroplasty or microfracture procedure ; or 
      2. Autologous chondrocyte transplantation; or  
      3. Chondroplasties of focal cartilage defects; or  
      4. Surgery for intra-articular cartilage fractures; or  
      5. Surgical treatment of osteochondritis dissecans; or
      6. Treatment of an intra-articular fracture of the knee (e.g., tibial plateau fracture repair); or 
    5. Members who have undergone certain surgeries and may not be able to benefit optimally from active PT, for example members with:

      1. Dupuytren's contracture; or 
      2. Extensive tendon fibrosis; or 
      3. Mental and behavioral disorders; or 
      4. Reflex sympathetic dystrophy; or
    6. Members who are unable to undergo active PT.

    Note: Where the CPM device is used for surgical rehabilitation, the use of this device must commence within 2 days following surgery to meet medical necessity guidelines.  Although the usual duration of CPM usage is 7 to 10 days, up to 3 weeks of CPM therapy may be considered medically necessary upon individual consideration.  Use of the CPM machine beyond 21 days post-op is not supported by the medical literature.  There is insufficient evidence to justify use of these devices for longer periods of time or for other applications.

  2. Aetna considers CPM machines experimental and investigational for all other indications, including the ones listed below (not an all-inclusive list), because there is insufficient scientific evidence to support the use of these machines for other indications:
    • Motion or strength following metacarpophalangeal arthroplasty
    • Rehabilitation following back surgery
    • Rehabilitation following foot surgery (e.g., for congenital talipes equinovarus (clubfoot))
    • Rehabilitation following quadriceps tear
    • Rehabilitation following temporomandibular joint repair
    • Rehabilitation following total hip replacement
    • Rehabilitation of distal radial fractures
    • Rheumatoid arthritis in the absence of a covered indication
    • Treatment of low back pain or trauma.

Published studies suggest that continuous passive motion (CPM) can improve range of motion (ROM) in those patients undergoing surgical release of arthrofibrosis of the knee or manipulation of the knee under anesthesia.  In these settings, CPM provides for early post-operative motion and is considered a substitute for active physical therapy (PT).  Once the patient is participating in active PT, CPM is no longer medically necessary.  These observations may be extended to other joints, such as the elbow where arthrofibrosis is a common complication of trauma.

Of all the applications of CPM, the scientific evidence is perhaps strongest for its use in promoting cartilage growth.  In addition, clinical studies suggest that CPM can enhance cartilage healing during the non weight-bearing period following surgery for intra-articular cartilage fractures, chondroplasties of focal cartilage defects and surgical treatment of osteochondritis dissecans.  Once the patient is weight-bearing, CPM is no longer necessary.

Systematic evidence reviews have found weak or limited evidence for CPM for a number of indications.  In a Cochrane review, Handoll et al (2006) evaluated the effects of rehabilitation interventions in adults with conservatively or surgically treated distal radial fractures.  Fifteen trials, involving 746 mainly female and older patients, were included.  Initial treatment was conservative, involving plaster cast immobilization, in all but 27 participants whose fractures were fixed surgically.  Though some studies were well-conducted, others were methodologically compromised.  For interventions started during immobilization, there was weak evidence of improved hand function for hand therapy in the days after plaster cast removal, with some beneficial effects continuing 1 month later (1 trial).  There was weak evidence of improved hand function in the short- term, but not in the longer term (3 months), for early occupational therapy (1 trial), and of a lack of differences in outcome between supervised and unsupervised exercises (1 trial).  For interventions started post-immobilization, there was weak evidence of a lack of clinically significant differences in outcome in patients receiving formal rehabilitation therapy (4 trials), passive mobilization (2 trials), ice or pulsed electromagnetic field (1 trial), or whirlpool immersion (1 trial) compared with no intervention.  There was weak evidence of a short-term benefit of CPM (post-external fixation) (1 trial), intermittent pneumatic compression (1 trial) and ultrasound (1 trial).  There was weak evidence of better short-term hand function in participants given physiotherapy than in those given instructions for home exercises by a surgeon (1 trial).  The authors concluded that available evidence from randomized controlled trials is insufficient to establish the relative effectiveness of the various interventions used in the rehabilitation of adults with fractures of the distal radius.

A systematic evidence review by Michlovitz et al (2004) of non-surgical interventions to restore ROM to persons with injuries to the upper extremities found insufficient evidence to support the use of continuous passive motion.  The systematic evidence review identified 1 cohort study, which found CPM to be similar to ROM exercises at improving ROM and extension, but better at improving flexion, after surgery for elbow flexion contractures.  The review identified another cohort study that found CPM to be no better than passive ROM exercises after rotator cuff repair.  The investigators concluded that "[t]he quality and quantity of evidence in this area were moderate to low."

In a Cochrane review, Massy-Westropp et al (2008) compared the effectiveness of post-operative therapeutic regimens for increasing hand function following metacarpophalangeal (MCP) arthroplasty in adults with rheumatoid arthritis.  Randomized controlled trials and controlled clinical trials were accepted if they evaluated the efficacy of a post-operative therapeutic regimen for MCP arthroplasty.  No data analyses were performed as only 1 controlled clinical trial was found.  The data from that study were described.  These investigators' search only identified 1 controlled clinical trial involving 22 subjects.  The majority of the evidence for various splinting and exercise regimens consisted of case series and case studies.  Results from the 1 (poor quality) trial suggested that the use of CPM is not effective in increasing motion or strength after MCP arthroplasty.  The authors concluded that well-designed randomized controlled trials which compare the effectiveness of different therapeutic splinting programs following MCP arthroplasty are required.  At this time, the results of 1 study suggested that CPM alone is not recommended for increasing motion or strength after MCP arthroplasty.

In a randomized controlled study, Lenssen and colleagues (2008) examined the effectiveness of prolonged CPM use in the home setting as an adjunct to standardized PT.  Effectiveness was assessed in terms of faster improvements in ROM as well as functional recovery, measured at the end of the active treatment period, 17 days after surgery.  A total of 60 patients with knee osteoarthritis undergoing total knee arthroplasty (TKA) and experiencing early post-operative flexion impairment were randomized into 2 treatment groups.  The experimental group received CPM + PT for 17 consecutive days after surgery, whereas the usual care group received the same treatment during the in-hospital phase (i.e., about 4 days), followed by PT alone (usual care) in the first 2 weeks after hospital discharge.  From 18 days to 3 months following surgery, both groups received standardized PT.  The primary focus of rehabilitation was functional recovery (e.g., ambulation) and regaining ROM in the knee.  Prolonged use of CPM slightly improved short-term ROM in patients with limited ROM at the time of discharge after TKA when added to a semi-standard PT program.  Assessment at 6 weeks and 3 months after surgery found no long-term effects of this intervention.  These researchers also did not detect functional benefits of the improved ROM at any of the outcome assessments.  The authors concluded that although results indicate that prolonged CPM use might have a small short-term effect on ROM, routine use of prolonged CPM in patients with limited ROM at hospital discharge should be re-considered, since neither long-term effects nor transfer to better functional performance was detected.

In a Cochrane review, Gray et al (2012) evaluated the effectiveness of interventions for congenital talipes equinovarus (CTEV).  The review found, among other things, a lack of evidence for continuous passive motion treatment following major foot surgery. The authors could draw no conclusions from other included trials because of the limited use of validated outcome measures and lack of available raw data; and future randomized controlled trials should address these issues.

There is also a scarcity of peer-reviewed evidence on the use of CPM for other conditions including degenerative joint diseases (e.g., rheumatoid arthritis) as well as rehabilitation following quadriceps tear and temporo-mandibular joint repair.

Ring and colleagues (1998) examined if a post-operative rehabilitation protocol incorporating CPM would increase the total ROM obtained 6 months following silicone interposition arthroplasty of the metacarpophalangeal joints in patients with rheumatoid arthritis.  A prospective trial randomizing patients to receive either CPM or the standard dynamic splint protocol (modified Madden protocol) was undertaken.  A total of 15 hands (60 joints) were treated with the modified Madden protocol and 10 hands (40 joints) had CPM.  The mean 6-month post-operative ROM was 7 degrees in the modified Madden cohort compared with 39 degrees in the CPM cohort, representing an improvement of 22 degrees in the modified Madden cohort compared with an improvement of only 5 degrees in the CPM cohort.  Residual ulnar deviation 8 degrees versus 12 degrees and grip strength (2.3 kgf versus 3.7 kgf) were both lower in the CPM cohort.  The authors concluded that incorporation of the CPM machine in the post-operative rehabilitation protocol does not offer sufficient advantages to justify the added costs.

An UpToDate review on “Total joint replacement for severe rheumatoid arthritis” (Weisman and Rinaldi, 2013) states that “It is unclear whether the use of continuous passive motion devices in the postoperative management of total knee arthroplasty results in enough clinical benefit to justify the inconvenience and expense of the procedure”.

In a systematic review, Rogan and colleagues (2013) evaluated treatment effects of CPM after surgical cartilage repair.  These researchers performed a literature search in the Cochrane Central Register of Controlled Trials, EMBASE, International Clinical Trials Registry Platform, MEDLINE, Trip Database and in bibliographies of included studies.  Two independent researchers evaluated the quality of original investigations by the Cochrane Risk of Bias tool.  Systematic reviews were checked by the CBO/Dutch Cochrane Centre Guideline.  A total of 1,541 studies were initially retrieved from the databases.  After screening for inclusion criteria, 1 review and 10 original papers could be included for further evaluation.  Studies showed methodological weaknesses.  Heterogeneity of outcome measures and the fact that 6 of 9 studies with a 1-group pre-post design measured the combined effect of surgical treatment and CPM prevented a meta-analysis.  The authors concluded that 3 studies described significant improvements with regard to subjective outcome such as pain, swelling, Quality Life Survey, Knee Society score, WOMAC score or rating Cincinnati due to the surgical treatment and the CPM intervention of cartilage defects in the knee;  6 (case) studies suggested an enhanced cartilage quality of the patients after CPM.  They stated that more high-quality RCTs are needed to provide high-level evidence.

Tabor (2013) determined which total knee replacement (TKR) patients, if any, benefit from the use of the CPM machine.  For the study period, most patients received active PT.  Patients were placed in the CPM machine if, on post-operative day 1, they had a ROM less than or equal to 45° and/or pain score of 8 or greater on a numeric rating scale (NRS) of 0 to 10, 0 being no pain and 10 being the worst pain.  Both groups of patients healed at similar rates.  The incidence of adverse events, length of stay, and functional outcomes was comparable between groups.  The author concluded that given the demonstrated lack of relative benefit to the patient and the cost of the CPM, this study supported discontinuing the routine use of the CPM.

Nikolaou and colleagues (2014) noted that TKR is a widely used operation that has radically improved the quality of life of millions of people during the last few decades.  However, some technical details, concerning the surgical procedure and the rehabilitation following TKA, are still a matter of a strong debate.  In this review of the literature, these investigators have included the best evidence available of the last decade, in an effort to shed light on some of the most controversial subjects related to TKR surgery: (i) Posterior-stabilized or cruciate-retaining prosthesis? (ii) To use a tourniquet during operation or not? (iii) Do patients need CPM for their post-surgery rehabilitation? and (iv) To resurface patella or not?  These are some of the most controversial topics that until now have been persistent dilemmas for the orthopedic surgeon.  Results of this systematic review of the literature were highly controversial.  These conflicting results were an indication that larger and more well-conducted high-quality trials are needed in order to gain more secure answers.

In a RCT, Herbold et al (2014) examined the effects of using a CPM device for individuals with poor ROM after a TKR admitted for post-acute rehabilitation.  Adults (n = 141) after TKR with initial active knee flexion less than 75° on admission to the Inpatient rehabilitation facility (IRF) were included in this study.  Two randomized groups: group 1 (n = 71) received the conventional 3 hours of therapy per day, and group 2 (n = 70) received the addition of daily CPM use for 2 hours throughout their length of stay.  The primary outcome measure was active knee flexion ROM.  Secondary outcome measures included active knee extension ROM, length of stay, estimate of function using the FIM and Timed Up and Go test, girth measurement, and self-reported Western Ontario and McMaster Universities Osteoarthritis Index scores.  All subjects significantly improved from admission to discharge in all outcome measures.  However, there were no statistically significant differences in any of the discharge outcome measures of the CPM group compared with the non-CPM group.  The authors concluded that CPM did not provide an additional benefit over the conventional interventions used in an IRF for patient after TKR, specifically in patients with poor initial knee flexion ROM after surgery.

In a RCT, Boese and colleagues (2014) determined the effectiveness of CPM following TKA.  Post-operative outcomes of interest were: swelling, drop in hemoglobin, self-reported pain scores, ROM, and hospital length of stay.  A total of 160 subjects were randomized into 1 of 3 treatment groups: (i) CPM device on and moving from the immediate post-operative period, (ii) CPM device on and stationary at 90 degree flexion for the 1st night and then moving throughout the rest of their stay, and (iii) no CPM (n = 55, 51, and 54, respectfully).  Subjects were followed during the 1st and 2nd post-operative day until their first follow-up appointment approximately 3 to 4 weeks post-operatively.  Cost of CPM was further evaluated. The authors concluded that CPM provided no benefit to patients recovering from TKA.

On behalf of the National Health and Medical Research Council (NHMRC) of Australia, Mak et al (2014) evaluated the evidence for different interventions in the pre-operative, peri-operative and post-operative care for people undergoing elective TKR and total hip replacement (THR).  A multi-disciplinary working group comprising consumers, managers and clinicians from the areas of orthopedics, rheumatology, aged care and rehabilitation evaluated randomized controlled trials (RCTs) and systematic reviews/meta-analyses concerning aspects of pre-operative, peri-operative and post-operative clinical care periods for THR/TKR through systematic searching of Medline, Embase, CENTRAL and the Cochrane Database of Systematic Reviews from May 2007 to April 2011.  Multiple reviewers determined study eligibility and one or more members extracted primary study findings.  The body of evidence was assessed and specific recommendations made according to NHMRC guidelines.  A total of 25 aspects were identified for review.  Recommendations for 16 of 25 areas of care were made: impact of waiting, multi-disciplinary preparation, pre-operative exercise, smoking cessation, interventions for co-morbid conditions, predictors of outcome, clinical pathways, implementation of a blood management program, antibiotic prophylaxis, regional anesthesia and analgesia, use of a tourniquet in knee replacement, venous thromboembolism prophylaxis, early post-operative cryotherapy, early mobilization and CPM.  In the post-operative period, study heterogeneity across all aspects of care precluded specific recommendations.  The authors concluded that there was a deficiency in the quality of the evidence supporting key aspects of the continuum of care for primary THR/TKR surgery.  Consequently, recommendations were limited.  Prioritization and funding for research into areas likely to impact clinical practice and patient outcomes after elective joint replacement surgery are the next important steps.

In a Cochrane review, He and colleagues (2014) examined the effectiveness of CPM therapy for preventing venous thromboembolism (VTE) in patients after TKA.  For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Coordinator searched the Specialised Register (last searched February 2014), CENTRAL (2014, Issue 1), Ovid MEDLINE (to week 1 February 2014) and EMBASE (to Week 07 2014).  Randomized controlled trials comparing the use of CPM with control in preventing deep venous thrombosis (DVT) or pulmonary embolism (PE) following TKA were selected for analysis.  People aged 18 years and older who had undergone TKA were included in this review.  These researchers excluded studies of patients who presented with DVT at baseline.  The experimental and control groups received similar postoperative care and therapy other than the CPM.  Two review authors independently assessed the citations retrieved by the search strategies for reports of relevant RCTs.  They independently selected trials that satisfied the inclusion criteria, extracted data and undertook quality assessment.  Effects were estimated as risk ratios (RRs), mean differences or standardized mean differences (SMD) with 95 % CIs.  Meta-analyses were performed using a fixed-effect model for continuous variables.  Where heterogeneity existed (determined by the I(2) statistic) a random-effects model was used.  A total of 11 RCTs involving 808 participants met the inclusion criteria.  The methodological quality of the included studies was variable and most of the pre-defined outcomes were reported by only 1 or 2 studies, therefore the quality of the evidence was low.  Five studies with a total of 405 patients reported the incidence of DVT.  In the CPM group (205 patients) 36 developed DVT (18 %) compared to 29 (15 %) in the control group (200 patients).  The results of the meta-analysis showed no evidence that CPM had any effect on preventing VTE after TKA (RR 1.22, 95 % CI: 0.84 to 1.79).  One trial (150 participants) did not find PE in any of the patients during hospitalization or in the subsequent 3 months.  Pulmonary embolism was not reported in the other included studies.  None of the trials reported deaths among the included participants.  The authors concluded that there is not enough evidence from the available RCTs to conclude that CPM reduces VTE after TKA.  These researchers cannot assess the effect of CPM on mortality because no such events occurred among the participants of these trials.  The quality of the evidence was low.  The results were supported by only a small number of studies, most of which are of low to moderate quality.

In a Cochrane review, Harvey et al (2014) evaluated the benefits and harms of CPM and standard post-operative care versus similar post-operative care, with or without additional knee exercises, in people with TKA.  These investigators searched the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 12), MEDLINE (January 1966 to 24 January 2013), EMBASE (January 1980 to 24 January 2013), CINAHL (January 1982 to 24 January 2013), AMED (January 1985 to 24 January 2013) and PEDro (to 24 January 2013).  Randomized controlled trials in which the experimental group received CPM, and both the experimental and control groups received similar post-operative care and therapy following TKA in people with arthritis were selected for analysis.  Two review authors independently selected trials for inclusion, extracted data and assessed risk of bias.  The primary outcomes of interest were active knee flexion ROM, pain, quality of life, function, participants' global assessment of treatment effectiveness, incidence of manipulation under anesthesia and adverse events.  The secondary outcomes were passive knee flexion ROM, active knee extension ROM, passive knee extension ROM, length of hospital stay, swelling and quadriceps strength.  These researchers estimated effects for continuous data as mean differences or SMD, and effects for dichotomous data as risk ratios; all with 95 % CIs.  If appropriate, these investigators performed meta-analyses using random-effects models.  They identified 684 papers from the electronic searches after removal of duplicates and retrieved the full reports of 62 potentially eligible trials.  A total of 24 RCTs of 1,445 participants met the inclusion criteria; 4 of these trials were new to this update.  There was moderate-quality evidence to indicate that CPM does not have clinically important short-term effects on active knee flexion ROM: mean knee flexion was 78 degrees in the control group, CPM increased active knee flexion ROM by 2 degrees (95 % CI: 0 to 5) or absolute improvement of 2 % (95 % CI: 0 % to 4 %).  The medium- and long-term effects were similar although the quality of evidence is lower.  There was low-quality evidence to indicate that CPM does not have clinically important short-term effects on pain: mean pain was 3 points in the control group, CPM reduced pain by 0.4 points on a 10-point scale (95 % CI: -0.8 to 0.1) or absolute reduction of -4 % (95 % CI: -8 % to 1 %).  There was moderate-quality evidence to indicate that CPM does not have clinically important medium-term effects on function: mean function in the control group was 56 points, CPM decreased function by 1.6 points (95 % CI: -6.1 to 2.0) on a 100-point scale or absolute reduction of -2 % (95 % CI: -5 % to 2 %).  The SMD was -0.1 standard deviations (SD) (95 % CI: -0.3 to 0.1).  There was moderate-quality evidence to indicate that CPM does not have clinically important medium-term effects on quality of life: mean quality of life was 40 points in the control group, CPM improved quality of life by 1 point on a 100-point scale (95 % CI: -3 to 4) or absolute improvement of 1 % (95 % CI: -3 % to 4 %).  There was very low-quality evidence to indicate that CPM reduces the risk of manipulation under anesthesia; risk of manipulation in the control group was 7.2 %, risk of manipulation in the experimental group was 1.6 %, CPM decreased the risk of manipulation by 25 fewer manipulations per 1,000 (95 % CI: 9 to 64) or absolute risk reduction of -4 % (95 % CI: -8 % to 0 %).  The risk ratio (RR) was 0.3 (95 % CI: 0.1 to 0.9).  There was low-quality evidence to indicate that CPM reduces the risk of adverse events; risk of adverse events in the control group was 16.3 %, risk of adverse events in the experimental group was 17.9 %, CPM decreased the risk of adverse event by 150 fewer adverse events per 1,000 (95 % CI: 103 to 216) or absolute risk reduction of -1 % (95 % CI: -5 % to 3 %).  The RR was 0.9 (95 % CI: 0.6 to 1.3).  The estimates for risk of manipulation and adverse events were very imprecise and the estimate for the risk of adverse events did not distinguish between a clinically important increase and decrease in risk.  There was insufficient evidence to determine the effect of CPM on participants' global assessment of treatment effectiveness.  The authors 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 developing adverse events although the quality of evidence supporting these findings is very low and low, respectively.  The effects of CPM on other outcomes are unclear.

Husted et al (2014) noted that traditions are passed on from experienced surgeons to younger fellows and become "the right way to do it".  Traditions associated with arthroplasty surgery may, however, not be evidence-based and may be potentially deleterious to both patients as well as society, increasing morbidity and mortality, slowing early functional recovery, and increasing cost.  These investigators identified selected traditions and performed a literature search using relevant search criteria (June 2014).  They presented a narrative review grading the studies according to evidence, and suggested some lines of future research.  These researchers presented traditions and evaluated them against the published evidence.  Pre-operative removal of hair, urine testing for bacteria, use of plastic adhesive drapes intra-operatively, and pre-warming of the operation room should be abandoned; as should use of a tourniquet, a space suit, a urinary catheter, and closure of the knee in extension.  The safety and effectiveness of tranexamic acid is supported by meta-analyses.  Post-operatively, there is no evidence to support postponement of showering or postponement of changing of dressings to after 48 hours.  They also stated that there is no evidence to recommend routine dental antibiotic prophylaxis, CPM, the use of compression stockings, cooling for pain control or reduction of swelling, flexion of at least 90 degrees as a discharge criterion following TKA, or having restrictions after THA.  The authors presented evidence supporting the use of NSAIDs, early mobilization, allowing early travel, and a low hemoglobin trigger for transfusion.  Moreover, they stated that revision of traditions and myths surrounding hip and knee arthroplasty towards more contemporary evidence-based principles can be expected to improve early functional recovery, thus reducing morbidity, mortality, and costs.

Also, an UpToDate review on “Total knee arthroplasty” (Martin et al, 2014) states that “The use of continuous passive motion (CPM) devices to improve knee range of motion is common in postoperative rehabilitative care in many institutions, but there is uncertainty regarding whether the clinical benefits justify the inconvenience and expense of CPM”.  Also, an UpToDate review on “Total joint replacement for severe rheumatoid arthritis” (Weisman and Rinaldi, 2014) states that “It is unclear whether the use of continuous passive motion devices in the postoperative management of total knee arthroplasty results in enough clinical benefit to justify the inconvenience and expense of the procedure”.

Furthermore, the American Physical Therapy Association (APTA) recommended against CPM following TKR.  In the Choosing Wisely Campaign, the APTA stated “Don’t use continuous passive motion machines for the postoperative management of patients following uncomplicated total knee replacement”.  The APTA stated that CPM treatment does not lead to clinically important effects on short- or long-term knee extension, long-term knee flexion, long-term function, pain and quality of life in patients undergoing TKA.

In a Cochrane review, Gray et al (2014) evaluated the effectiveness of interventions for congenital talipes equinovarus (CTEV).  On April 29, 2013, these investigators searched CENTRAL (2013, Issue 3 in The Cochrane Library), MEDLINE (January 1966 to April 2013), EMBASE (January 1980 to April 2013), CINAHL Plus (January 1937 to April 2013), AMED (1985 to April 2013), and the Physiotherapy Evidence Database (PEDro to April 2013).  They also searched for ongoing trials in the WHO International Clinical Trials Registry Platform (2006 to July 2013) and (to November 2013); and checked the references of included studies.  They searched NHSEED, DARE and HTA for information for inclusion in the Discussion.  Randomized controlled trials and quasi-RCTs evaluating interventions for CTEV were selected for analysis.  Participants were people of all ages with CTEV of either 1 or both feet.  Two authors independently assessed risk of bias in included trials and extracted the data.  They contacted authors of included trials for missing information; and collected adverse event information from trials when it was available.  These researchers identified 14 trials in which there were 607 participants; 1 of the trials was newly included at this 2014 update.  The use of different outcome measures prevented pooling of data for meta-analysis even when interventions and participants were comparable.  All trials displayed bias in 4 or more areas.  One trial reported on the primary outcome of function, though raw data were not available to be analyzed.  These investigators were able to analyze data on foot alignment (Pirani score), a secondary outcome, from 3 trials.  Two of the trials involved participants at initial presentation.  One reported that the Ponseti technique significantly improved foot alignment compared to the Kite technique.  After 10 weeks of serial casting, the average total Pirani score of the Ponseti group was 1.15 (95 % CI: 0.98 to 1.32) lower than that of the Kite group.  The second trial found the Ponseti technique to be superior to a traditional technique, with average total Pirani scores of the Ponseti participants 1.50 lower (95 % CI: 0.72 to 2.28) after serial casting and Achilles tenotomy.  A trial in which the type of presentation was not reported found no difference between an accelerated Ponseti or standard Ponseti treatment.  At the end of serial casting, the average total Pirani scores in the standard group were 0.31 lower (95 % CI: -0.40 to 1.02) than the accelerated group.  Two trials in initial cases found relapse following Ponseti treatment was more likely to be corrected with further serial casting compared to the Kite groups which more often required major surgery (risk difference 25 % and 50 %).  There is a lack of evidence for different plaster casting products, the addition of botulinum toxin A during the Ponseti technique, different types of major foot surgery, CPM treatment following major foot surgery, or treatment of relapsed or neglected cases of CTEV.  Most trials did not report on adverse events.  In trials evaluating serial casting techniques, adverse events included cast slippage (needing replacement), plaster sores (pressure areas) and skin irritation.  Adverse events following surgical procedures included infection and the need for skin grafting.  The authors concluded that from the limited evidence available, the Ponseti technique produced significantly better short-term foot alignment compared to the Kite technique and compared to a traditional technique.  The quality of this evidence was low to very low.  An accelerated Ponseti technique may be as effective as a standard technique, according to moderate quality evidence.  Relapse following the Kite technique more often led to major surgery compared to relapse following the Ponseti technique.  These investigators also noted that no conclusions could be drawn from other included trials because of the limited use of validated outcome measures and lack of available raw data.  They stated that future RCTs should address these issues,

Hill et al (2014) stated that the use of CPM in the post-operative treatment of intra-articular fractures around the knee is increasing.  These researchers determined the effects of a CPM device on knee ROM after operative treatment of intra-articular fractures around the knee.  A total of 40 patients with intra-articular fractures of either the proximal part of the tibia or the distal end of the femur were prospectively randomized to the use of CPM or standardized PT in the immediate post-operative period for 48 hours.  The primary outcome was knee ROM.  Secondary outcome measures included pain scores, Lower Limb Outcomes Questionnaire scores, and Short Musculoskeletal Function Assessment scores.  Evaluations were conducted at 48 hours, 2 weeks, 6 weeks, 3 months, and 6 months post-operatively.  There was no significant difference in knee extension between the groups at any time-point measured.  Knee flexion was significantly greater at 48 hours in the group managed with the CPM device than in the group managed without the CPM device (p < 0.005).  However, there was no significant difference in knee flexion at any other time-point.  There was no significant difference in knee pain at 48 hours between groups.  Six (30 %) of 20 patients were unable to tolerate the use of the CPM device.  There were no significant differences in overall complications.  The authors concluded that the findings of this study suggested that the use of CPM in the immediate post-operative period following the treatment of intra-articular fractures offered no benefit with regard to knee motion at 6 months and was not tolerated by all patients.

In a prospective, randomized, waiting-list-controlled (WLC) trial, Gavish et al (2014) evaluated the effectiveness of a novel, angular, CPM device for self-treatment at home in patients with mild-to-moderate, non-specific, chronic low back pain (LBP).  A total of 36 patients with a score less than or equal to 6 on the NRS for pain were enrolled; 28 patients completed treatment.  Participants were randomized to receive the Kyrobak (Radiancy, Hod-hasharon, Israel) at enrollment [immediate treatment (IT) group] or 3 weeks later (WLC group).  Self-treatment was prescribed for 10 minutes, 1 to 3 times per day, for 3 weeks.  The treatment period was followed by a 3-week follow-up period.  Primary outcome was self-reported pain level (NRS).  Three weeks of self-treatment with the Kyrobak reduced pain levels significantly in the IT group compared with the WLC group {mean [standard deviation (SD)] ΔNRS score from baseline to post-treatment: IT group, 1.4 (1.5), 95 % CI: 0.5 to 2.3; WLC group, -0.1 (2.2), 95 % CI: -1.1 to 1.2; effect mean difference 1.5}.  This benefit was maintained over the follow-up period [from baseline to end of follow-up, mean (SD) ΔNRS score 1.1 (1.8), 95 % CI: 0.4 to 1.8].  Multi-linear regression analysis found that higher baseline pain resulted in greater pain reduction (p = 0.003).  Eighty-three percent of participants with a baseline NRS score greater than 4.35 (threshold determined by logistic regression, p = 0.01) achieved the minimal important change criterion of ΔNRS score greater than or equal to 2.  Daily NRS score reduced gradually over the treatment period [regression slope -0.052 (0.01), 95 % CI: -0.07 to -0.03].  The authors concluded that preliminary evidence suggested that the Kyrobak may be beneficial for short-term relief of non-specific, chronic LBP, particularly in participants with a moderate level of pain.  They stated that a longer treatment period may lead to a further reduction in pain.  These preliminary findings need to be validated by well-designed studies with larger sample size and longer follow-up periods.

CPT Codes / HCPCS Codes/ ICD-10 Codes
Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":
ICD-10 codes will become effective as of October 1, 2015 :
Other CPT codes related to the CPB:
21240 - 21243 Arthroplasty, temporomandibular joint
27430 Quadricepsplasty (eg, Bennett or Thompson type)
97110 Therapeutic procedure, one or more areas, each 15 minutes; therapeutic exercises to develop strength and endurance, range of motion and flexibility
97140 Manual therapy techniques (e.g., mobilization/manipulation, manual lymphatic drainage, manual traction), one or more regions, each 15 minutes
HCPCS codes covered if selection criteria are met:
E0935 Continuous passive motion exercise device for use on knee only
E0936 Continuous passive motion exercise device for use other than knee
Other HCPCS codes related to the CPB:
E1700 Jaw motion rehabilitation system
E1701 Replacement cushions for jaw motion rehabilitation system, package of 6
E1702 Replacement measuring scales for jaw motion rehabilitation system, package of 200
E1800 Dynamic adjustable elbow extension/flexion device, includes soft interface material
E1802 Dynamic adjustable forearm pronation/supination device, includes soft interface material
E1805 Dynamic adjustable wrist extension/flexion device, includes soft interface material
E1810 Dynamic adjustable knee extension/flexion device, includes soft interface material
E1812 Dynamic knee, extension/flexion device with active resistance control
E1815 Dynamic adjustable ankle extension/flexion device, includes soft interface material
E1820 Replacement soft interface material, dynamic adjustable extension/flexion device
E1825 Dynamic adjustable finger extension/flexion device, includes soft interface material
E1830 Dynamic adjustable toe extension/flexion device, includes soft interface material
E1840 Dynamic adjustable shoulder flexion/abduction/rotation device, includes soft interface material
ICD-10 codes covered if selection criteria are met:
G90.50 - G90.59 Complex regional pain syndrome I (CRPS I)
M23.200 - M23.369
M24.80 - M24.9
Internal derangement of knee and other joints
M72.0 Palmar fascial fibromatosis [Dupuytren]
M75.00 - M77.9 Peripheral and other enthesopathies
Numerous options Musculoskeletal and connective tissue injuries, sequela
M93.20 - M93.29 Osteochondritis dissecans
S83.501+ - S83. 529+ Sprain of cruciate ligament of knee
Z96.60 - Z96.698 Presence of orthopedic joint implants
ICD-10 codes not covered for indications listed in the CPB:
M05.00 - M14.89 Inflammatory polyarthropathies [in the absence of a listed covered condition]
M24.60 - M24.698 Ankylosis of joint
M26.60 - M26.69 Temporomandibular joint disorders
M43.20 - M43.28 Fusion of spine
M43.8x9, M53.84 - M53.9 Other spinal dorsopathies
M48.04 - M48.08 Spinal stenosis (other than cervical)
M53.2x7 - M53.2x8, M53.3, M53.87 - M53.88 Disorders of the sacrum
M54.00 - M54.09 Panniculitis affecting regions of the neck and back
M54.10 - M54.18 Radiculopathy
M54.30 - M54.9 Sciatica, lumbago, low back pain and other dorsalgia
M54.6 Pain in thoracic spine
Q66.0 Congenital talipes equinovarus
S12.000+ - S12.9xx+,
S22.000+ - S22.9xx+,
S32.000+ - S32.9xx+
Fracture of spine and trunk [includes sequela]
S13.100+ - S13.29x+
S23.100+ - S23.29x+
S33.100+ - S33.39x+
Dislocations of vertebra, other, and unspecified
S13.8xx+ - S13.9xx+
S23.3xx+, S23.9xx+
S33.5xx+ - S33.9xx+
Sprains of back, other and unspecified
S14.101+ - S14.159+
S24.101+ - S24.159+
S34.101+ - S34.139+
Spinal cord injury [includes sequela]
S52.501+ - S52.599+ Fracture of lower end of radius (open or closed)
S72.141+ - S72.26x+ Intertrochanteric or subtrochanteric fracture of femur
S92.00 - S92.066 Fracture of calcaneus
S92.201(A or B) - S92.356 (A or B) Fracture of other and unspecified tarsal and metatarsal bone(s) [closed and open]
S93.601 - S93.699 Sprain of foot
Z96.641 - Z96.649 Presence of artificial hip joint

The above policy is based on the following references:
    1. U.S. Department of Health and Human Services, Center for Medicare and Medicaid Services (CMS). Durable Medical Equipment Reference List. Coverage Issues Manual Section 60-9. Baltimore, MD: CMS; November 1996. 
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