The efficacy of exercises for the treatment of chronic low back pain.
| ISRCTN | ISRCTN12458386 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12458386 |
| Secondary identifying numbers | N0060055840 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 16/07/2008
- 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
Dr Jeremy Lewis
Scientific
Scientific
Physiotherapy Dept
Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom
| Phone | +44 (0)181 746 8406 |
|---|---|
| jeremy.lewis@chelwest.nhs.uk |
Study information
| Study design | Randomised single-blind placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Musculoskeletal Diseases: Chronic low back pain |
| Intervention | Eighty patients with chronic low back pain (> 3 months) were randomized to one of the following treatments, involving 8 treatments over 8 weeks: 1. one to one treatment involving 30 minutes of manual therapy (mobilizations to the spine) and spinal stabilization exercises 2. 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. |
| Intervention type | Other |
| Primary outcome measure | Prior to July 2008: Visual analogue scale (pain intensity). Objective measures (lumbar range of movement, straight leg raise, Biering-Sorenson test). Functional test. Modified July 2008 to: Quebec back pain disability questionnaire |
| Secondary outcome measures | Added July 2008: 1. Subjective rating of change 2. Visual analogue scale for pain 3. Perceived level of fitness 4. Analgesic use 5. Number of cigarettes / day 6. Level of confidence relating to back pain 7. Lumbar range of movement 8. Range of straight leg raise |
| Overall study start date | 01/01/2000 |
| Completion date | 01/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 subjects |
| Key inclusion criteria | Added July 2008: 1. Subjects between the ages of 18 to 75 years 2. Fluency in English 3. Mechanical low back pain for more than 3 months (of a non-radicular nature). Mechanical pain was defined as LBP which increased with movement. |
| Key exclusion criteria | 1. Patients with cardiac, respiratory, kidney, blood pressure or blood circulatory problems, spinal surgery, fracture, inflammatory or infectious diseases of the spine, metabolic disease, neurological deficit, rheumatoid arthritis or diabetes 2. Health professionals and staff members at the institution where data was collected 3. Potential subjects who were pregnant or attempting to become pregnant 4. Patients who were not capable of participating in a graded exercise program were also excluded |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 01/08/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Physiotherapy Dept
London
SW10 9NH
United Kingdom
SW10 9NH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Chelsea and Westminster Healthcare NHS Trust (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 | 01/04/2005 | Yes | No |
