Spine stabilisation trial
| 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
Scientific
Nuffield Orthopaedic Centre
Windmill Road
Headington
Oxford
OX3 7LD
United Kingdom
| jeremy.fairbank@ndos.ox.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/1996 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/06/1996 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nuffield Orthopaedic Centre
Oxford
OX3 7LD
United Kingdom
OX3 7LD
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| 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
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
