Total disc replacement versus multidisciplinary rehabilitation in patients with chronic low back pain and degenerative discs: Eight-year follow-up of a randomized controlled multicenter trial

Publication date: Available online 2 June 2017
Source:The Spine Journal
Author(s): Håvard Furunes, Kjersti Storheim, Jens Ivar Brox, Lars Gunnar Johnsen, Jan Sture Skouen, Eric Franssen, Tore K Solberg, Leiv Sandvik, Christian Hellum
Background ContextLumbar total disc replacement is a treatment option for selected patients with chronic low back pain that is non-responsive to conservative treatment. The long-term results of disc replacement compared to multidisciplinary rehabilitation have not been reported previously.PurposeWe aimed to assess the long-term relative efficacy of lumbar total disc replacement compared to multidisciplinary rehabilitation.DesignWe undertook a multicenter randomized controlled trial at five university hospitals in Norway.Patient SampleThe sample consists of 173 patients aged 25-55 years with chronic low back pain and localized degenerative changes in the lumbar intervertebral discs.Outcome MeasuresThe primary outcome was self-reported physical function (Oswestry Disability Index, ODI) at eight-year follow-up in the intention to treat population. Secondary outcomes included self-reported low back pain (visual analogue scale, VAS), quality of life (EuroQol, EQ-5D), emotional distress (Hopkins Symptom Check List, HSCL-25), occupational status, patient satisfaction, drug use, complications and additional back surgery.MethodsPatients were randomly assigned to lumbar total disc replacement or multidisciplinary rehabilitation. Self-reported outcome measures were collected eight years after treatment. The study was powered to detect a difference of ten ODI points between the groups. The study has not been funded by the industry.Results605 patients were screened for eligibility, of whom 173 were randomly assigned treatment. 77 patients (90%) randomized to surgery and 74 patients (85%) randomized to rehabilitation responded at eight-year follow-up. Mean improvement on the ODI was 20.0 points (95% CI 16.4-23.6, p≤0.0001) in the surgery group and 14.4 points (95% CI 10.7-18.1, p≤0.0001) in the rehabilitation group. Mean difference between the groups at eight-year follow-up was 6.1 points (95% CI 1.2-11.0, p=0.02). Mean difference in favor of surgery on secondary outcomes were 9.9 points on VAS (95 % CI 0.6-19.2, p= 0.04) and 0.16 points on HSCL-25 (95 % CI 0.01-0.32, p=0.04). 18 patients (24 %) in the surgery group and four patients (6 %) in the rehabilitation group reported full recovery (p=0.002). There were no significant differences between the groups in EQ-5D, occupational status, satisfaction with care or drug use. In the per protocol analysis, the mean difference between groups was 8.1 ODI points (95 % CI 2.3-13.9, p=0.01) in favor of surgery. 43 of 61 patients (70 %) in the surgery group and 26 of 52 patients (50 %) in the rehabilitation group had a clinically important improvement (15 ODI points or more) from baseline (p=0.03). The proportion of patients with a clinically important deterioration (six ODI-points or more) were not significantly different between the groups. 21 patients (24 %) randomized to rehabilitation had crossed over and had undergone back surgery since inclusion. 12 patients (14 %) randomized to surgery had undergone additional back surgery. One serious adverse event after disc replacement is registered (<1%).ConclusionsSubstantial long-term improvement can be expected both after disc replacement and multidisciplinary rehabilitation. The difference between groups is statistically significant in favor of surgery, but smaller than the pre-specified clinical important difference of ten ODI points that the study was designed to detect. Future research should aim to improve selection criteria for disc replacement and multidisciplinary rehabilitation.



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