Early physiotherapy management of back pain in primary care: a comparison of physical treatments versus a back pain management programme
| ISRCTN | ISRCTN32765488 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32765488 |
| Protocol serial number | M RB 218233 |
| Sponsor | Keele University (UK) |
| Funders | The National Lotteries Charities Board (via North Staffordshire Medical Institute) (UK) - Project No. RB218223, £191,227, North Staffordshire Primary Care Research Consortium (UK) £112,516 |
- Submission date
- 01/07/2003
- Registration date
- 01/07/2003
- Last edited
- 04/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Primary Care Sciences Research Centre
Keele University
Keele
ST5 5BG
United Kingdom
| Phone | +44 (0)1782 583916 |
|---|---|
| e.m.hay@cphc.keele.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To compare the clinical effectiveness, in primary care, of a brief pain management programme delivered by physiotherapists with that of a programme of spinal manual physiotherapy in the treatment of non-specific low back pain of less than 12 weeks duration. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Acute low back pain |
| Intervention | 1. A brief pain management programme with no 'hands on' physiotherapy but focusing on education to change behaviour and attitudes, in addition to exercises to increase fitness. 2. A course of "hands on" spinal manual therapy plus specific back exercises prescribed on the basis of a detailed assessment of spinal pain, mobility and function by the physiotherapist. |
| Intervention type | Other |
| Primary outcome measure(s) |
The primary outcome was change in self-reported back pain related disability at 12 months as measured on the Roland and Morris Disability Questionnaire. |
| Key secondary outcome measure(s) |
1. Participants global assessment of change compared with baseline |
| Completion date | 30/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 402 |
| Key inclusion criteria | 1. Aged 18 - 64 years inclusive 2. Acute episode of low back pain of less than 12 weeks duration 3. First or second consultation with general practitioner (GP) 4. Able to give written informed consent |
| Key exclusion criteria | 1. On long term sick leave for low back pain 2. Already seen by other health care professional (e.g. physio) for this episode of back pain prior to randomisation 3. Diagnosis of osteoporosis or inflammatory arthritis 4. Systemic steroid therapy for more than three months duration 5. Pregnancy 6. Undergoing current treatment for cancer 7. Terminal illness 8. Previous hip or back surgery or fracture 9. Abdominal surgery within the last three months 10. Roland and Morris Disability Questionnaire score (primary outcome measure) less than 2 |
| Date of first enrolment | 01/07/2000 |
| Date of final enrolment | 30/06/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
ST5 5BG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/06/2005 | Yes | No |
