title: Novel continuous passive motion device for self-treatment of chronic lower back pain: a randomised controlled study.
abstract: OBJECTIVE
  To evaluate the efficacy of a novel, angular, continuous passive motion device for self-treatment at home in patients with mild-to-moderate, non-specific, chronic low back pain (LBP).
  
  
  METHODS
  Prospective, randomised, waiting-list-controlled (WLC) trial.
  
  
  METHODS
  Recruitment and assessment were conducted at the Koren Centre for Physical Therapy. Self-treatment was performed at home.
  
  
  METHODS
  Thirty-six patients with a score ≤6 on the numeric rating scale (NRS) for pain were enrolled. Twenty-eight patients completed treatment.
  
  
  METHODS
  Participants were randomised to receive the Kyrobak (Radiancy, Hod-hasharon, Israel) at enrolment [immediate treatment (IT) group] or 3 weeks later (WLC group). Self-treatment was prescribed for 10minutes, one to three times per day, for 3 weeks. The treatment period was followed by a 3-week follow-up period.
  
  
  METHODS
  Primary outcome was self-reported pain level (NRS).
  
  
  RESULTS
  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% confidence interval (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 >4.35 (threshold determined by logistic regression, P=0.01) achieved the minimal important change criterion of ΔNRS score ≥2. Daily NRS score reduced gradually over the treatment period [regression slope -0.052 (0.01), 95% CI -0.07 to -0.03].
  
  
  CONCLUSIONS
  Preliminary evidence suggests that the Kyrobak may be beneficial for short-term relief of non-specific, chronic LBP, particularly in participants with a moderate level of pain. A longer treatment period may lead to a further reduction in pain.
authors.affiliation: Institute for Medical Research, The Hebrew University, Faculty of Medicine, Jerusalem, Israel. Electronic address: lilachg@ekmd.huji.ac.il.
authors.forename: L
authors.initials: L
authors.lastname: Gavish
authors.affiliation: Spine Unit, Department of Orthopaedic Surgery, Shaare Tzedek Medical Centre, Jerusalem, Israel.
authors.forename: Y
authors.initials: Y
authors.lastname: Barzilay
authors.affiliation: Koren Centre for Physical Therapy, Mevasseret-Zion, Israel.
authors.forename: C
authors.initials: C
authors.lastname: Koren
authors.affiliation: Koren Centre for Physical Therapy, Mevasseret-Zion, Israel.
authors.forename: A
authors.initials: A
authors.lastname: Stern
authors.affiliation: Herzog Memorial Hospital, Jerusalem, Israel.
authors.forename: L
authors.initials: L
authors.lastname: Weinrauch
authors.affiliation: Friedman Skin and Laser Centre, Jerusalem, Israel.
authors.forename: D J
authors.initials: DJ
authors.lastname: Friedman
mesh_terms: D000368:Aged; D004599:Electric Stimulation Therapy / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006699:Home Care Services; D006801:Humans; D007557:Israel; D017116:Low Back Pain / Q000175:diagnosis / Q000534:rehabilitation*; D008297:Male; D008875:Middle Aged; D015915:Motion Therapy, Continuous Passive / Q000295:instrumentation*; D010147:Pain Measurement; D017060:Patient Satisfaction; D011446:Prospective Studies; D012648:Self Care / Q000295:instrumentation*; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
keywords: Continuous passive; Home care device; Low back pain; Motion therapy; Self-treatment