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 |
| Secondary identifying numbers | M RB 218233 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Elaine May
Scientific
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | The primary outcome was change in self-reported back pain related disability at 12 months as measured on the Roland and Morris Disability Questionnaire. |
| Secondary outcome measures | 1. Participants global assessment of change compared with baseline 2. Pain location (body chart) 3. Rating of pain severity (visual analogue scale [VAS]) and pain nature (short form McGill pain questionnaire) 4. Psychological distress (the distress and risk assessment method [DRAM]) 5. Fear of movement (Tampa scale of kinesiophobia), coping strategies (coping strategies questionnaire) 6. Satisfaction with treatment (VAS) 7. Days off work since start of current episode 8. Co-interventions (health care utilisation and medication usage) |
| Overall study start date | 01/07/2000 |
| Completion date | 30/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Primary Care Sciences Research Centre
Keele
ST5 5BG
United Kingdom
ST5 5BG
United Kingdom
Sponsor information
Keele University (UK)
University/education
University/education
Keele University
Keele
ST5 5BG
England
United Kingdom
| Website | http://www.keele.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/00340yn33 |
Funders
Funder type
Charity
The National Lotteries Charities Board (via North Staffordshire Medical Institute) (UK) - Project No. RB218223, £191,227
No information available
North Staffordshire Primary Care Research Consortium (UK) £112,516
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 | 01/06/2005 | Yes | No |
