| Source of record | UK Trials |
| ISRCTN | ISRCTN56323917 |
| Date ISRCTN assigned | 10/07/2002 |
| Local reference number(s) | C0647 |
| Public title | A comparison of the effectiveness of three physiotherapy regimes commonly used to reduce disability in patients with chronic low back pain |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Chronic low back pain |
| Study hypothesis | Chronic low-back pain has enormous personal and socio-economic costs locally, nationally and internationally. However, diagnosis is difficult and treatment controversial. Many forms of Physiotherapy are advocated including: individual manipulative treatment, group exercises aiming to restore the protective function of supposedly dysfunctional deep trunk muscles or group exercises aiming to reduce psychological distress and fear of movement. All three treatments can reduce pain and disability but it is not known if one treatment is more effective or cost-effective. Nor is it known if treatment success is related to the proposed mechanism, such as change of muscle function. We will compare these three treatments whilst measuring some of the factors they propose to change. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Non-specific lower back pain of 3/12 duration |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/2002 |
| Anticipated end date | 01/02/2005 |
| Status of trial | Completed |
| Target number of participants | 212 |
| Interventions | 1. Individual physiotherapy
2. Group functional restoration programme
3. Group spinal stabilisation training |
| Primary outcome measure(s) | Roland Morris Disability Questionaire |
| Secondary outcome measure(s) | 1. Pain (Numerical Analogue Scale)
2. Health-related quality of life (EQ-5D)
3. Work status and other economic effects of back-pain (Client Service Receipt Inventory [CSRI])
4. Patient satisfaction with outcome and satisfaction with treatment (7-point descriptive scale)
5. Emotional distress (28-item General Health Questionnaire [GHQ-28])
6. Fear-avoidance (Tampa scale of kinesiophobia)
7. Coping strategies (Coping Strategies Questionnaire [CSQ])
8. Transversus abdominis, obliquus internus, obliquus externus thickness (real-time ultrasound) |
| Publications | Results in http://www.ncbi.nlm.nih.gov/pubmed/17572614 |
| Sources of funding | Arthritis Research Campaign (UK) |
| Sponsor name | Arthritis Research Campaign (UK) |
| Sponsor details | Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
United Kingdom
S41 7TD |
| Sponsor email | info@arc.org.uk |
| Sponsor website | http://www.arc.org.uk |
| Contact name | Dr Duncan Critchley |
| Contact details | Applied Biomedical Science Research Group
King's College London
Guy's Campus
London
United Kingdom
SE1 1UL |
| Contact telephone | +44 (0)20 7836 5454 |
| Contact email | duncan.critchley@kcl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN56323917 |
| Date last extracted from ISRCTN register | 17/04/2008 |
