Spine stabilisation trial

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN88854663
• Date of registration: 25/10/2000
• Prospective Registration: No
• Primary sponsor: Medical Research Council (MRC) (UK)
• Public title: Spine stabilisation trial
• Date of first enrolment: 01/06/1996
• Target sample size: 400
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN88854663
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)

Countries of recruitment

United Kingdom

Contacts

• Name: Jeremy Fairbank

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients who were candidates for surgical stabilisation of the spine were eligible if the clinician and patient were uncertain which of the study treatment strategies was best.
2. Patients had to be aged between 18 and 55, with more than a 12 month history of chronic low back pain (with or without referred pain) and irrespective of whether they had had previous root decompression or discectomy.
Exclusion criteria: 1. Patients were ineligible if the surgeon considered that any medical or other reasons made one of the trial interventions unsuitable.
2. These included infection or other comorbidities (inflammatory disease, tumours, fractures), psychiatric disease, inability or unwillingness to complete the trial questionnaires, or pregnancy.
3. If patients had had previous surgical stabilisation surgery of the spine they were also excluded.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic low back pain
Musculoskeletal Diseases
Chronic low back pain

Intervention(s)

1. Surgical stabilisation (spinal fusion)
2. Special non-operative rehabilitation

Follow-up: 6,12 months, 2 years post randomisation

Primary Outcome(s)

The two primary measures at 24 months included a back pain specific questionnaire and a standardised walking test. The Oswestry low back pain disability index is scored from 0% (no disability) to 100% (totally disabled or bedridden) and designed to assess limitations of various activities of daily living. The shuttle walking test is a standardised, progressive, maximal test of walking speed and endurance.

Secondary Outcome(s)

1. The short form 36 general health questionnaire (SF-36) includes 35 items summarised in two measures related to physical and mental health. Each scale ranges from 0 (worst health state) to 100 (best health state). The summary measures are transformed to give a population mean of 50 (SD 10). The SF-36 is recommended as an outcome assessment for spinal disorders because it provides strong psychometric support and extensive normative data.
2. Psychological assessment: we used the distress and risk assessment method (DRAM), which includes the modified Zung depression index and somatic perception questionnaire, to assess anxiety and depression.
3. Complications: we recorded the intraoperative use of anaesthetic agents, implants; radiological investigations; complications of surgery and any adverse effects of rehabilitation; postoperative complications, implant failure and repeat surgery and personal items and devices purchased by the patient because of lower back pain. Work status was monitored. We recorded 'obvious pseudoarthrosis' only where it was clear to the treating surgeon that fusion had failed and that this was a problem to the patient.

Secondary ID(s)

G9431172

Source(s) of Monetary Support

Medical Research Council (MRC) (UK)