Improving the effectiveness of primary care for low back pain: the Sub-grouping for Targeted Treatment (STarT Back) trial
| ISRCTN | ISRCTN37113406 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37113406 |
| Secondary identifying numbers | 17741 |
- Submission date
- 23/11/2006
- Registration date
- 05/01/2007
- Last edited
- 08/10/2012
- 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
Mrs Elizabeth E J Mason
Scientific
Scientific
Keele University
Keele
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
| Phone | +44 (0)1782 583900 |
|---|---|
| e.mason@cphc.keele.ac.uk |
Study information
| Study design | Pragmatic randomised controlled 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 acronym | STarT Back |
| Study objectives | 1. Patients at low risk can be managed effectively with a brief intervention and will remain at low risk subsequently. 2. Patients at high risk who are managed within a framework that targets modifiable physical and psychosocial risk factors will have reduced risk of future disabling chronic back pain. |
| Ethics approval(s) | Approval received from the North Staffordshire LREC in February 2007 (ref: 07/Q2604/5). |
| Health condition(s) or problem(s) studied | Low back pain |
| Intervention | 1. Targeted treatment arm: The new intervention to be tested in this trial is targeted treatment, which will be allocated according to the sub-grouping tool, and administered on a stepped-care basis. As described above, all patients randomised to this treatment arm will be seen on their first visit to the Community Back Pain Clinic by a study physiotherapist who will provide an initial 30-minute standard intervention and inform them of their treatment plan according to the results of the screening tool. Treatment allocation will be as follows: a. Group one (low risk): Initial 30-minute physiotherapy intervention alone b. Group two (medium risk): Initial 30-minute physiotherapy intervention plus medium risk group intervention c. Group three (high risk): Initial 30-minute physiotherapy intervention plus high risk group intervention 2. Non targeted treatment: Current best practice physiotherapy |
| Intervention type | Other |
| Primary outcome measure | 1. Roland Morris Disability Questionnaire 2. Pain Catastrophising Scale |
| Secondary outcome measures | 1. Recurrence of back pain 2. Fear avoidance (Tampa Scale of Kinesiophobia) 3. Back pain bothersomeness 4. Anxiety and depression (Hospital Anxiety and Depression Scale) 5. Self-reported global change in back problem 6. Pain intensity 7. Patient perceptions of their low back pain 8. Patient satisfaction 9. Overall health status (EuroQol instrument [EQ5D], Short Form health survey version two [SF12 vs2]) |
| Overall study start date | 01/04/2007 |
| Completion date | 01/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 800 |
| Key inclusion criteria | 1. Males and females age 18 and over with non-specific low back pain 2. Able to give informed and written consent |
| Key exclusion criteria | 1. Persons with red flags indicative of possible serious spinal pathology 2. Serious co-morbidity 3. Psychiatric illness/personality disorder 4. Recent spinal surgery (less than six months) 5. Pregnancy 6. Already receiving treatment for this episode of back pain |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 01/06/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
ST5 5BG
United Kingdom
Sponsor information
Keele University (UK)
University/education
University/education
Keele
Newcastle-Under-Lyme
ST5 5BG
England
United Kingdom
| e.mason@cphc.keele.ac.uk | |
| Website | http://www.keele.ac.uk/ |
"ROR" |
https://ror.org/00340yn33 |
Funders
Funder type
Charity
Arthritis Research Campaign (project grant 17741) (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? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 22/04/2008 | Yes | No | |
| Results article | results | 29/10/2011 | Yes | No | |
| Results article | results | 01/06/2012 | Yes | No | |
| Results article | cost-utility results | 01/11/2012 | Yes | No |
