Early rehabilitation after lumbar disc surgery is not effective or cost-effective compared to no referral: a randomised trial and economic evaluation

Question: Is referral for early rehabilitation after lumbar disc surgery effective and cost-effective compared to no referral? Design: Multicentre, randomised, controlled trial, and economic evaluation with concealed allocation and intention-to-treat-analysis. Participants: Adults who underwent discectomy for a herniated lumbar disc, confirmed by magnetic resonance imaging, and signs of nerve root compression corresponding to the herniation level. Intervention: Early rehabilitation (exercise therapy) for 6 to 8 weeks, versus no referral, immediately after discharge. Outcome measures: In line with the recommended core outcome set, the co-primary outcomes were: functional status (Oswestry Disability Index); leg and back pain (numerical rating scale 0 to 10); global perceived recovery (7-point Likert scale); and general physical and mental health (SF12), assessed 3, 6, 9, 12 and 26 weeks after surgery. The outcomes for the economic evaluation were quality of life and costs, measured at 6, 12 and 26 weeks after surgery. Results: There were no clinically relevant or statistically significant overall mean differences between rehabilitation and control for any outcome adjusted for baseline characteristics: global perceived recovery (OR 1.0, 95% CI 0.6 to 1.7), functional status (MD 1.5, 95% CI -3.6 to 6.7), leg pain (MD 0.1, 95% CI -0.7 to 0.8), back pain (MD 0.3, 95% CI -0.3 to 0.9), physical health (MD -3.5, 95% CI -11.3 to 4.3), and mental health (MD -4.1, 95% CI -9.4 to 1.3). After 26 weeks, there were no significant differences in quality-adjusted life years (MD 0.01, 95% CI -0.02 to 0.04 points) and societal costs (MD -(sic)527, 95% CI -2846 to 1506). The maximum probability for the intervention to be cost-effective was 0.75 at a willingness-to-pay of (sic)32 000/quality-adjusted life year. Conclusion: Early rehabilitation after lumbar disc surgery was neither more effective nor more cost-effective than no referral. Trial registration: Netherlands Trial Register NTR3156. (C) 2017 Published by Elsevier B.V. on behalf of Australian Physiotherapy Association.