| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN61808774 |
| Date ISRCTN assigned | 12/09/2003 |
| Local reference number(s) | M0001078851 |
| Public title | A Randomised Controlled Trial (RCT) of the effect on chronic low back pain of a naturopathic osteopathy intervention |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Musculoskeletal Diseases: Back pain |
| Study hypothesis | Does a naturopathic osteopathy intervention improve pain, disability and sense of well being in chronic low back pain? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 240 clients aged between 20 and 65 presenting at ten general practices in Brent in the summer of 2000 with low back pain of over three months duration. Random allocation to an intervention arm and usual care. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/04/2000 |
| Anticipated end date | 01/06/2003 |
| Status of trial | Completed |
| Target number of participants | 240 |
| Interventions | Questionnaire inquiry of disability, pain and sense of well being administered at recruitment, 3, 6, 12 months, and at 5 years. Half will be randomised to an intervention arm that comprises treatment at the British College of Naturopathy and Osteopathy (BCNO) by third/fourth year students under the supervision of experienced trainer practitioners. This intervention will be naturopathic osteopathy and include patient diaries. Up to seven treatments will be given, expecting an average of five weekly treatments. |
| Primary outcome measure(s) | Assessment of:
1. Disability using the Roland Morris Score
2. Self competence using the Perceived Pain Management Competence Scale
3. Beliefs using the Back Beliefs Questionnaire
4. Pain using the Von Korff questionnaire
5. Well-being using the SF12.
All of these are self-administered questionnaires. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | The West London Research Network (WeLReN) |
| Sponsor name | Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK) |
| Sponsor details | The Department of Health
Richmond House
79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 (0)20 7307 2623 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.doh.gov.uk |
| Contact name | Dr Paul Thomas |
| Contact details | Kilburn Park Medical Centre
12 Cambridge Gardens
Kilburn
London
United Kingdom
NW6 5AY |
| Contact telephone | +44 020 7624 2414 |
| Contact fax | +44 |
| Contact email | p.r.thomas@imperial.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN61808774 |
| Date last extracted from ISRCTN register | 17/04/2008 |
