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.

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 = 2480; 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.

Cost-effectiveness of providing patients with information on managing mild low-back symptoms in an occupational health setting.

BACKGROUND: Evidence shows that low back specific patient information is effective in sub-acute low back pain (LBP), but effectiveness and cost-effectiveness (CE) of information in early phase symptoms is not clear. We assessed effectiveness and CE of patient information in mild LBP in the occupational health (OH) setting in a quasi-experimental study. METHODS: A cohort of employees (N = 312, aged <57) with non-specific, mild LBP (Visual Analogue Scale between 10-34 mm) was selected from the respondents of an employee survey (N = 2480; response rate 71 %). A random sample, representing the natural course of LBP (NC, N = 83; no intervention), was extracted as a control group. Remaining employees were invited (181 included, 47 declined, one excluded) into a randomised controlled study with two 1:1 allocated parallel intervention arms ("Booklet", N = 92; "Combined", N = 89). All participants received the "Back Book" patient information booklet and the Combined also an individual verbal review of the booklet. Physical impairment (PHI), LBP, health care (HC) utilisation, and all-cause sickness absence (SA) were assessed at two years. CE of the interventions on SA days was analysed by using direct HC costs in one year, two years from baseline. Multiple imputation was used for missing values. RESULTS: Compared to NC, the Booklet reduced HC costs by 196€ and SA by 3.5 days per year. In 81 % of the bootstrapped cases the Booklet was both cost saving and effective on SA. Compared to NC, in the Combined arm, the figures were 107€, 0.4 days, and 54 %, respectively. PHI decreased in both interventions. CONCLUSIONS: Booklet information alone was cost-effective in comparison to natural course of mild LBP. Combined information reduced HC costs. Both interventions reduced physical impairment. Mere booklet information is beneficial for employees who report mild LBP in the OH setting, and is also cost saving for the health care system. TRIAL REGISTRATION: ClinicalTrials.gov NCT00908102.

The effectiveness of two active interventions compared to self-care advice in employees with non-acute low back symptoms: a randomised, controlled trial with a 4-year follow-up in the occupational health setting.

OBJECTIVE: Evaluate the effectiveness of two active interventions, aimed at secondary prevention of low back pain (LBP), in occupational health. METHODS: We performed a survey of LBP (n=2480; response rate 71%) and randomized 143 employees (66% males, 45 years) with LBP over 34 mm on VAS into Rehabilitation (n=43), Exercise (n=43) or self-care (n=40) groups. Primary outcomes were LBP, physical impairment (PI) and health-related quality of life (HRQoL) for two years and sickness absence (SA) days during four years (LBP specific, total). RESULTS: Compared to self-care, exercise reduced LBP at 12 months (mean difference (MD) -12 mm; 95% CI -21 to -2) and improved HRQoL at 12 and 24 months (0.03; 0.00 to 0.05), but did not reduce PI. The MDs of SA days in four years were -17 (-70 to 35, total) and -15 (-47 to 13, LBP specific). Exercise reduced the probability of LBP specific SA during the third and fourth year. Compared to self-care, Rehabilitation reduced LBP at 3 months (-10 mm; -19 to -1) and 6 months (-10 mm; -20 to - 1), but was not effective in HRQoL or PI. The MDs of SA days in four years were -41 (-93 to 8; total) and 5 (-30 to 47; LBP specific). Rehabilitation reduced the probability of total SA during first and second year and amount of total SA days in the fourth year. CONCLUSIONS: Among employees with relatively mild LBP, both interventions reduced pain, but the effects on SA and PI were minor. Exercise improved HRQoL. The effect sizes were rather small. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT00908102.