A randomised clinical trial of subgrouping and targeted treatment for low back pain compared with best current care. The STarT Back Trial Study Protocol.
BACKGROUND
Back pain is a major health problem and many sufferers develop persistent symptoms. Detecting relevant subgroups of patients with non-specific low back pain has been highlighted as a priority area for research, as this could enable better secondary prevention through the targeting of prognostic indicators for persistent, disabling symptoms. We plan to conduct a randomised controlled trial to establish whether subgrouping using a novel tool, combined with targeted treatment, is better than best current care at reducing long-term disability from low back pain.


METHODS
We will recruit 800 participants aged 18 years and over with non-specific low back pain from 8-10 GP practices within two Primary Care Trusts in Staffordshire, England. Our primary outcome measures are low back pain disability and catastrophising. Secondary outcomes include back pain intensity, global change, leg pain, fear avoidance, anxiety, depression, illness perceptions, patient satisfaction, overall health status and cost-effectiveness. Data will be collected before randomisation, and 4 and 12 months later. Participants are randomised to receive either newly developed interventions, delivered by trained physiotherapists and targeted according to subgroups defined by tool scores, or best current care.


CONCLUSIONS
This paper presents detail on the rationale, design, methods and operational aspects of the trial.


BACKGROUND
Current Controlled Trials ISRCTN37113406.
Hay
Elaine M
EM
Arthritis Research Campaign National Primary Care Centre, Primary Care Sciences, Keele University, Staffordshire, ST5 5BG, UK. e.m.hay@cphc.keele.ac.uk
Dunn
Kate M
KM
Hill
Jonathan C
JC
Lewis
Martyn
M
Mason
Elizabeth E
EE
Konstantinou
Kika
K
Sowden
Gail
G
Somerville
Simon
S
Vohora
Kanchan
K
Whitehurst
David
D
Main
Chris J
CJ
D000328:Adult; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis* / Q000628:therapy*; D015337:Multicenter Studies as Topic; D017063:Outcome Assessment, Health Care / Q000379:methods; D010147:Pain Measurement; D017060:Patient Satisfaction; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D018401:Sample Size