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).

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 10minutes, 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)] 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.

Trial registration: ClinicalTrials.gov NCT01620281.

Keywords: Continuous passive; Home care device; Low back pain; Motion therapy; Self-treatment.