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Effectiveness of an innovative mattress overlay for improving rehabilitation in low back pain: a pilot randomized controlled study
Minetto MA, Gamerro G, Gays G, Vigo S, Caresio C, Gorji NE, Massazza G
Journal of Back and Musculoskeletal Rehabilitation 2018;31(6):1075-1083
clinical trial
3/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND AND OBJECTIVE: Sleep disorders should be routinely evaluated and treated in low back pain (LBP) patients because they represent an important contributor to pain. However, no study thus far has investigated the potential benefit to LBP management of a device improving the sleep quality. Therefore, aim of this study was to assess the effectiveness of an innovative mattress overlay as add-on treatment to LBP rehabilitation. METHODS: Thirty eight LBP patients were randomized to standard rehabilitation plus mattress overlay use (cases) or standard rehabilitation only (controls). The intervention duration was 2 months and the following assessments were performed before and after: pain intensity; level of perceived back disability and sleep health; spine mobility; thickness and echo intensity of the lumbar multifidus. RESULTS: Significant pre-post-intervention improvements were observed in cases for resting and movement pain, perceived back disability, sleep, fingertip-to-floor distance, multifidus thickness (approximate 6% increase) and echo intensity (approximate 13% decrease). On the contrary, all these variables remained constant between the two experimental phases in controls. CONCLUSIONS: A combination of rehabilitation and mattress overlay use seems an effective approach for improvement of pain, perceived back disability, sleep, spine mobility, and lumbar multifidus size and structure of LBP patients.

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