| Source of record | UK Trials |
| ISRCTN | ISRCTN12458386 |
| Date ISRCTN assigned | 30/09/2004 |
| Local reference number(s) | N0060055840 |
| Public title | The efficacy of exercises for the treatment of chronic low back pain. |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Musculoskeletal Diseases: Chronic low back pain |
| Study hypothesis | Experimental hypothesis: A specific exercise protocol will be clinically more beneficial as well as being more cost effective than other forms of treatment for 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 | 80 subjects. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
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| Anticipated start date | 01/01/2000 |
| Anticipated end date | 01/08/2003 |
| Status of trial | Completed |
| Target number of participants | 80 |
| Interventions | Randomised, single-blind, placebo-controlled clinical trial (RCT).
Eighty patients with chronic low back pain (> 3 months) were randomized to one of the following treatments, involving 8 treatments over 8 weeks:
(i) one to one treatment involving 30 minutes of manual therapy (mobilizations to the spine) and spinal stabilization exercises
(ii) a 10 station exercise class involving aerobic exercises, spinal stabilization exercises and manual therapy.
Three physiotherapists lead the hour long group with a maximum of 10 patients. Questionnaires were completed and physical measurements were taken by a blinded observer before randomization, at the completion of treatment, at 6 months and 12 months after the completion of treatment. The intention to treat principle was used in data analysis. |
| Primary outcome measure(s) | Visual analogue scale (pain intensity). Objective measures (lumbar range of movement, straight leg raise, Biering-Sorenson test). Functional test. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Chelsea and Westminster Healthcare NHS Trust |
| Sponsor name | Record Provided by the NHSTCT Register - 2004 Update - 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 email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Jeremy Lewis |
| Contact details | Physiotherapy Dept
Chelsea & Westminster Hospital
369 Fulham Road
London
United Kingdom
SW10 9NH |
| Contact telephone | +44 (0)181 746 8406 |
| Contact email | jeremy.lewis@chelwest.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN12458386 |
| Date last extracted from ISRCTN register | 17/04/2008 |
