SST: Spine Stabilisation Trial
|Dates:||1995 - completed 2004|
|Funding:||Medical Research Council|
|Collaborators:||Department of Orthopaedic Surgery, Nuffield Orthopaedic Hospital, Oxford|
The Medical Research Council (MRC) Spine Stabilisation Trial (SST) is a randomised controlled trial comparing alternative strategies for the management of patients with chronic low back pain. Its aim is to determine reliably whether surgical stabilisation of the spine is more or less effective and cost-effective at achieving worthwhile relief of symptoms than an intensive rehabilitation programme. The study includes patients with chronic back pain, for whom the responsible surgeon is substantially uncertain as to whether surgery or rehabilitation is the most appropriate treatment.
Outcome is assessed in terms of a range of patient disability, satisfaction and functional capacity measures. These include the Oswestry Disability Index, the Shuttle Walking Test, the SF-36 health questionnaire and the EuroQol EQ-5D questionnaire. Secondary output measures include the indication of pseudarthrosis and neurological damage and the return to paid employment. In addition, the study focusses on the re-operation rates and the rates of implant failure of those in the operation arm. In the framework of the economic evaluation, data are collected on the costs of the alternative treatments, the costs of medication and subsequent hospital visits, the costs of visits to various medical practitioners, the costs of any adaptations and special equipment incurred by the patient and the costs of caring for patients at home
Main findings: At two years post randomization, surgical stabilization was found to be significantly more expensive than intensive rehabilitation (mean cost difference £3304, 95% CI £2317 to £4291), and was associated with a non significant QALY gain of 0.068 (95% CI -0.020 to 0.156). The resulting incremental cost per QALY was £48588. Thirty eight patients randomized to intensive rehabilitation however subsequently went on to receive surgery. If this trend were to continue beyond two years, a policy in which patients with chronic low back pain undergo surgery may eventually prove to be cost-effective when compared with a policy in which patients first try intensive rehabilitation.
Wilson-MacDonald J, Fairbank J, Frost H, Yu LM, Barker K, Collins R, Campbell H. The MRC Spine Stabilisation Trial: Surgical methods, outcomes, costs and complications of surgical stabilization.
Spine, In Press
Rivero-Arias, O, Campbell, H, Gray, A, Fairbank, J, Frost, H, and Wilson-MacDonald, J (2005). Surgical stabilisation of the spine compared with a programme of intensive rehabilitation for the management of patients with chronic low back pain: cost utility analysis based on a randomised controlled trial. BMJ 330(7502):1239
Campbell H, Rivero-Arias O, Johnston K, Gray A, Fairbank J, and Frost H (2006) Responsiveness of objective, disease-specific, and generic outcome measures in patients with chronic low back pain: an assessment for improving, stable, and deteriorating patients.