ISRCTN ISRCTN88854663
DOI https://doi.org/10.1186/ISRCTN88854663
Secondary identifying numbers G9431172
Submission date
25/10/2000
Registration date
25/10/2000
Last edited
30/07/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Jeremy Fairbank
Scientific

Nuffield Orthopaedic Centre
Windmill Road
Headington
Oxford
OX3 7LD
United Kingdom

Email jeremy.fairbank@ndos.ox.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo 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.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedChronic low back pain
Intervention1. Surgical stabilisation (spinal fusion)
2. Special non-operative rehabilitation

Follow-up: 6,12 months, 2 years post randomisation
Intervention typeOther
Primary outcome measureThe 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 measures1. 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.
Overall study start date01/06/1996
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants400
Key inclusion criteria1. 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.
Key exclusion criteria1. 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.
Date of first enrolment01/06/1996
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Nuffield Orthopaedic Centre
Oxford
OX3 7LD
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 28/05/2005 Yes No