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Effectiveness of three interventions for secondary prevention of low back pain in the occupational health setting -- a randomised controlled trial with a natural course control
Rantonen J, Karppinen J, Vehtari A, Luoto S, Viikari-Juntura E, Hupli M, Malmivaara A, Taimela S
BMC Public Health 2018 May 8;18(598):Epub
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*

BACKGROUND: We assessed the effectiveness of three interventions that were aimed to reduce non-acute low back pain (LBP) related symptoms in the occupational health setting. METHODS: Based on a survey (n = 2,480; response rate 71%) on LBP, we selected a cohort of 193 employees who reported moderate LBP (visual analogue scale VAS > 34 mm) and fulfilled at least one of the following criteria during the past 12 months: sciatica, recurrence of LBP >= 2 times, LBP >= 2 weeks, or previous sickness absence. A random sample was extracted from the cohort as a control group (control, n = 50), representing the natural course of LBP. The remaining 143 employees were invited to participate in a randomised controlled trial (RCT) of three 1:1:1 allocated parallel intervention arms: multidisciplinary rehabilitation (rehab, n = 43); progressive exercises (physio, n = 43) and self-care advice (advice, n = 40). Seventeen employees declined participation in the intervention. The primary outcome measures were physical impairment (PHI), LBP intensity (visual analogue scale), health related quality of life (QoL), and accumulated sickness absence days. We imputed missing values with multiple imputation procedure. We assessed all comparisons between the intervention groups and the control group by analysing questionnaire outcomes at 2 years with ANOVA and sickness absence at 4 years by using negative binomial model with a logarithmic link function. RESULTS: Mean differences between the rehab and control groups were-3 (95% CI -5 to -1) for PHI, -13 (-24 to -1) for pain intensity, and 0.06 (0.00 to 0.12) for QoL. Mean differences between the physio and control groups were-3 (95% CI -5 to -1) for PHI, -13 (-29 to 2) for pain intensity, and 0.07 (0.01 to 0.13) for QoL. The main effects sizes were from 0.4 to 0.6. The interventions were not effective in reducing sickness absence. CONCLUSIONS: Rehab and physio interventions improved health related quality of life, decreased low back pain and physical impairment in non-acute, moderate LBP, but we found no differences between the advice and control group results. No effectiveness on sickness absence was observed. TRIAL REGISTRATION: Number NCT00908102 ClinicalTrials.gov.

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