Contact information
Type
Scientific
Primary contact
Mrs Elizabeth E J Mason
ORCID ID
Contact details
Keele University
Keele
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
+44 (0)1782 583900
e.mason@cphc.keele.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17741
Study information
Scientific title
Acronym
STarT Back
Study hypothesis
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
Approval received from the North Staffordshire LREC in February 2007 (ref: 07/Q2604/5).
Study design
Pragmatic randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/04/2007
Overall trial end date
01/06/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Males and females age 18 and over with non-specific low back pain
2. Able to give informed and written consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
800
Participant 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
Recruitment start date
01/04/2007
Recruitment end date
01/06/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
Sponsor information
Organisation
Keele University (UK)
Sponsor details
Keele
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
e.mason@cphc.keele.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Arthritis Research Campaign (project grant 17741) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. Protocol in http://www.ncbi.nlm.nih.gov/pubmed/18430242
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21963002
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22507360
4. 2012 cost-utility results in http://www.ncbi.nlm.nih.gov/pubmed/22492783
Publication citations
-
Results
Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM, Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial., Lancet, 2011, 378, 9802, 1560-1571, doi: 10.1016/S0140-6736(11)60937-9.
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Results
Main CJ, Sowden G, Hill JC, Watson PJ, Hay EM, Integrating physical and psychological approaches to treatment in low back pain: the development and content of the STarT Back trial's 'high-risk' intervention (StarT Back; ISRCTN 37113406)., Physiotherapy, 2012, 98, 2, 110-116, doi: 10.1016/j.physio.2011.03.003.
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Hay EM, Dunn KM, Hill JC, Lewis M, Mason EE, Konstantinou K, Sowden G, Somerville S, Vohora K, Whitehurst D, Main CJ, A randomised clinical trial of subgrouping and targeted treatment for low back pain compared with best current care. The STarT Back Trial Study Protocol., BMC Musculoskelet Disord, 2008, 9, 58, doi: 10.1186/1471-2474-9-58.
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Whitehurst DG, Bryan S, Lewis M, Hill J, Hay EM, Exploring the cost-utility of stratified primary care management for low back pain compared with current best practice within risk-defined subgroups., Ann. Rheum. Dis., 2012, 71, 11, 1796-1802, doi: 10.1136/annrheumdis-2011-200731.