Evaluation of the Oxfordshire Physiotherapy Service for patients with low back pain: a multicentre randomised controlled trial
ISRCTN | ISRCTN41782781 |
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DOI | https://doi.org/10.1186/ISRCTN41782781 |
Secondary identifying numbers | F0519 |
- Submission date
- 16/07/2002
- Registration date
- 16/07/2002
- Last edited
- 04/10/2007
- 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 Helen Frost
Scientific
Scientific
Faculty of Health Sciences
Physiotherapy Department
Queen Margaret University College
Duke Street
Leith
Edinburgh
EH6 8HF
United Kingdom
Phone | +44 (0)131 317 3654 |
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hfrost@qmuc.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Quality of life |
Scientific title | |
Study objectives | To measure the effectiveness of routine physiotherapy compared with an assessment session and advice from a physiotherapist for patients with low back pain. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Low back pain |
Intervention | Group 1: Advice group - This group will have a single contact with a physiotherapist who will offer self management advice as specified in the advice booklet (see below). Specific exercises will not be advised. Group 2: Routine physiotherapy treatment - The physiotherapists will decide on the content of treatment according to their assessment. Treatment will be restricted to a combination of the following techniques depending on the physiotherapists' clinical judgment: 1. Mobilisation techniques including manipulation 2. Soft tissue techniques 3. Individual exercise programmes 4. Heat or cold treatment. No electrotherapy or traction will be used. Trial participants will receive a maximum of six treatment sessions. Information will be recorded on the type of physiotherapy intervention and the level of training and clinical experience of the physiotherapist. Advice booklet: Patients in group 1 and group 2 will be given a standardised advice booklet that has been produced by a group of experts in the field of low back pain. The advice in the booklet will be explained by the physiotherapist in a session lasting up to 1 hour. It will encourage activity and discourage bed rest. |
Intervention type | Other |
Primary outcome measure | Scores on the Oswestry disability index at 12 months: 0% (no disability) to 100% (totally disabled or bed ridden). |
Secondary outcome measures | 1. Scores on the Oswestry disability index at two and six months 2. Scores on the Roland and Morris disability questionnaire at 2, 6, and 12 months 3. General health was measured with the 36-item Short Form health survey (SF-36) at 2, 6, and 12 months (higher scores indicate better health) 4. Patient perceived benefit of treatment was measured on a scale from 0 (no benefit) to 10 (maximum benefit) and on a dichotomous scale (perceived benefit or no perceived benefit) |
Overall study start date | 01/10/1997 |
Completion date | 01/01/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 286 |
Key inclusion criteria | 1. Aged 18+ years 2. Subacute (more than 6 weeks less than 3 months) or chronic (more than 3 months) mechanical low back pain 3. With or without leg pain or neurological signs |
Key exclusion criteria | 1. Patients with serious conditions including: 1.1. Systemic rheumatological disease 1.2. Gynaecological problems 1.3. Ankylosing spondylitis 1.4. Tumours 1.5. Infection 2. Past spinal operations 3. Treatment for physical problems in the past month 4. Referred for intensive functional restoration programmes |
Date of first enrolment | 01/10/1997 |
Date of final enrolment | 01/01/2001 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Faculty of Health Sciences
Edinburgh
EH6 8HF
United Kingdom
EH6 8HF
United Kingdom
Sponsor information
Arthritis Research Campaign (ARC) (UK)
Charity
Charity
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
info@arc.org.uk | |
Website | http://www.arc.org.uk |
https://ror.org/02jkpm469 |
Funders
Funder type
Charity
Arthritis Research Campaign (UK)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | Results | 25/09/2004 | Yes | No |