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

Keele University
Keele
Newcastle-Under-Lyme
ST5 5BG
United Kingdom

+44 (0)1782 583900
e.mason@cphc.keele.ac.uk

Study information

Study designPragmatic randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymSTarT Back
Study objectives1. 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) studiedLow back pain
Intervention1. 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 typeOther
Primary outcome measure1. Roland Morris Disability Questionnaire
2. Pain Catastrophising Scale
Secondary outcome measures1. 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 date01/04/2007
Completion date01/06/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target number of participants800
Key inclusion criteria1. Males and females age 18 and over with non-specific low back pain
2. Able to give informed and written consent
Key exclusion criteria1. 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 enrolment01/04/2007
Date of final enrolment01/06/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom

Sponsor information

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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
BMC - Part of Springer Nature Springer Nature