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
Protocol serial number	17741
Sponsor	Keele University (UK)
Funder	Arthritis Research Campaign (project grant 17741) (UK)

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

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

Study information

Primary study design	Interventional
Study design	Pragmatic randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	1. Roland Morris Disability Questionnaire 2. Pain Catastrophising Scale
Key secondary outcome measure(s)	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])
Completion date	01/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Keele University

Newcastle-Under-Lyme
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	29/10/2011		Yes	No
Results article	results	01/06/2012		Yes	No
Results article	cost-utility results	01/11/2012		Yes	No
Protocol article	Protocol	22/04/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes