Contact information
Type
Scientific
Primary contact
Mr Jeremy Fairbank
ORCID ID
Contact details
Nuffield Orthopaedic Centre
Windmill Road
Headington
Oxford
OX3 7LD
United Kingdom
jeremy.fairbank@ndos.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9431172
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Chronic low back pain
Intervention
1. Surgical stabilisation (spinal fusion)
2. Special non-operative rehabilitation
Follow-up: 6,12 months, 2 years post randomisation
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
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.
Overall trial start date
01/06/1996
Overall trial end date
31/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant 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.
Recruitment start date
01/06/1996
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nuffield Orthopaedic Centre
Oxford
OX3 7LD
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15911537
Publication citations
-
Results
Fairbank J, Frost H, Wilson-MacDonald J, Yu LM, Barker K, Collins R, , Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial., BMJ, 2005, 330, 7502, 1233, doi: 10.1136/bmj.38441.620417.8F.