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ISRCTN
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ISRCTN88854663
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DOI
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10.1186/ISRCTN88854663
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Spine stabilisation trial
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Scientific title
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Acronym
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N/A
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Serial number at source
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G9431172
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Study hypothesis
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To compare the outcome of surgical stabilisation (spinal fusion) with a special non-operative rehabilitation in patients with chronic low back pain considered suitable for spinal fusion.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Chronic low back pain
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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.
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Anticipated start date
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01/06/1996
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Anticipated end date
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31/12/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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400
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Interventions
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1. Surgical stabilisation (spinal fusion)
2. Special non-operative rehabilitation
Follow-up: 6,12 months, 2 years post randomisation
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15911537
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Contact name
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Mr
Jeremy
Fairbank
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Address
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Nuffield Orthopaedic Centre
Windmill Road
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 7LD
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Country
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United Kingdom
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Email
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jeremy.fairbank@ndos.ox.ac.uk
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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30/07/2009
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Date ISRCTN assigned
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25/10/2000
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