Randomised controlled trial (RCT) comparing long term effect of exercise to rehabilitate spinal stabilisation, manual therapy & an education booklet in the treatment of chronic back pain
| ISRCTN | ISRCTN53815070 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53815070 |
| Secondary identifying numbers | REC00075 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 08/01/2010
- 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
Ms Lucy Goldby
Scientific
Scientific
St George's Healthcare NHS Trust
St George's Hospital Physiotherapy
Blackshaw Road
London
SW17 0QT
United Kingdom
| lucy@balancephysio.com |
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 | The number of patients referred to Physiotherapy because of chronic low back pain continues to increase and it is well recognised that the management of these patients creates an increasing burden to the NHS. A growing body of evidence indicates that an active rehabilitation approach to these patients is effective at reducing pain and disability. More recently evidence has emerged that rehabilitating the deep lumbar stabilising muscles may reduce the recurrence rate of low back pain. In contrast, the effectiveness of standard NHS physiotherapy for low back pain has not been established, and whilst 50% of all patients referred to Physiotherapy outpatients have low back pain, to our knowledge there are no pragmatic studies concerned with investigating the effectiveness of this management strategy. We propose to conduct a randomised control trial to compare the effects of exercises to rehabilitate spinal stabilisation, manual therapy and as a control and minimal treatment condition, an education booklet in the conservative treatment of low back pain. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Spinal conditions |
| Intervention | 1. Exercises to rehabilitate spinal stabilisation 2. Manual therapy 3. (Control) minimal treatment condition, an education booklet in the conservative treatment of low back pain |
| Intervention type | Other |
| Primary outcome measure | 1. Pain (0-100 numerical rating scale for back pain intensity, 0-100 scale for leg pain intensity, The Pain Diagram) 2. Impairment (Shuttle walking test, modified Schober technique for range of lumbar flexion) 3. Disability (Revised Oswestry Pain Questionnaire, The Low Back Outcome Score) 4. Handicap (Low Back Outcome Score: Return to work/work status/sick leave) |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/1997 |
| Completion date | 01/09/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 346 (added 08/01/10, see publication) |
| Key inclusion criteria | Subjects aged between 18-65 years with Chronic Low Back Pain of at least 7 weeks duration will be recruited from the physiotherapy departments in St George's Healthcare. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/09/1997 |
| Date of final enrolment | 01/09/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St George's Healthcare NHS Trust
London
SW17 0QT
United Kingdom
SW17 0QT
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive London (UK)
No information available
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 | 01/05/2006 | Yes | No |
