Assessing a risk tailored intervention to prevent disabling low back pain--protocol of a cluster randomized controlled trial.
BACKGROUND
Although most patients with low back pain (LBP) recover within a few weeks a significant proportion has recurrent episodes or will develop chronic low back pain. Several mainly psychosocial risk factors for developing chronic LBP have been identified. However, effects of preventive interventions aiming at behavioural risk factors and unfavourable cognitions have yielded inconsistent results. Risk tailored interventions may provide a cost efficient and effective means to take systematic account of the individual risk factors but evidence is lacking.


METHODS
This study will be a cluster-randomised controlled trial comparing screening and a subsequent risk tailored intervention for patients with low back pain to prevent chronic low back pain compared to treatment as usual in primary care. A total of 600 patients from 20 practices in each study arm will be recruited in Berlin and Goettingen. The intervention comprises the following elements: Patients will be assigned to one of four risk groups based on a screening questionnaire. Subsequently they receive an educational intervention including information and counselling tailored to the risk group. A telephone/email consulting service for back pain related problems are offered independent of risk group assignment. The primary outcomes will be functional capacity and sick leave.


CONCLUSIONS
This trial will evaluate the effectiveness of screening for risk factors for chronic low back pain followed by a risk tailored intervention to prevent chronic low back pain. This trial will contribute new evidence regarding the flexible use of individual physical and psychosocial risk factors in general practice.


BACKGROUND
ISRCTN 68205910.
Schmidt
Carsten Oliver
CO
Department of General Practice, University of Göttingen, Humboldtallee 38, D-37073 Göttingen, Germany.
Chenot
Jean-François
JF
Pfingsten
Michael
M
Fahland
Ruth Anja
RA
Lindena
Gabriele
G
Marnitz
Ulf
U
Pfeifer
Klaus
K
Kohlmann
Thomas
T
D000328:Adult; D002985:Clinical Protocols; D003376:Counseling / Q000379:methods; D003866:Depressive Disorder / Q000453:epidemiology; D004185:Disability Evaluation; D005260:Female; D005858:Germany / Q000453:epidemiology; D006305:Health Status Indicators; D006801:Humans; D007407:Interviews as Topic / Q000379:methods; D017116:Low Back Pain / Q000453:epidemiology* / Q000517:prevention & control* / Q000523:psychology; D008297:Male; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010342:Patient Acceptance of Health Care / Q000523:psychology / Q000706:statistics & numerical data; D011788:Quality of Life / Q000523:psychology; D012017:Referral and Consultation; D040242:Risk Reduction Behavior; D012803:Sick Role; D055815:Young Adult