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Novel continuous passive motion device for self-treatment of chronic lower back pain: a randomised controlled study
Gavish L, Barzilay Y, Koren C, Stern A, Weinrauch L, Friedman DJ
Physiotherapy 2015 Mar;101(1):75-81
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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). DESIGN: Prospective, randomised, waiting-list-controlled (WLC) trial. SETTING: Recruitment and assessment were conducted at the Koren Centre for Physical Therapy. Self-treatment was performed at home. PARTICIPANTS: Thirty-six patients with a score < 6 on the numeric rating scale (NRS) for pain were enrolled. Twenty-eight patients completed treatment. INTERVENTIONS: 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 10 minutes, one to three times per day, for 3 weeks. The treatment period was followed by a 3-week follow-up period. MAIN OUTCOME MEASURES: 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)) delta NRS 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) delta NRS 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 delta NRS 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.

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