Cost-effectiveness of an intensive group training protocol compared to physiotherapy guideline care for sub-acute and chronic low back pain: design of a randomised controlled trial with an economic evaluation. [ISRCTN45641649].
BACKGROUND
Low back pain is a common disorder in western industrialised countries and the type of treatments for low back pain vary considerably.


METHODS
In a randomised controlled trial the cost-effectiveness and cost-utility of an intensive group training protocol versus physiotherapy guideline care for sub-acute and chronic low back pain patients is evaluated. Patients with back pain for longer than 6 weeks who are referred to physiotherapy care by their general practitioner or medical specialist are included in the study. The intensive group training protocol combines exercise therapy with principles of behavioural therapy ("graded activity") and back school. This training protocol is compared to physiotherapy care according to the recently published Low Back Pain Guidelines of the Royal Dutch College for Physiotherapy. Primary outcome measures are general improvement, pain intensity, functional status, work absenteeism and quality of life. The direct and indirect costs will be assessed using cost diaries. Patients will complete questionnaires at baseline and 6, 13, 26 and 52 weeks after randomisation.


CONCLUSIONS
No trials are yet available that have evaluated the effect of an intensive group training protocol including behavioural principles and back school in a primary physiotherapy care setting and no data on cost-effectiveness and cost-utility are available.
van der Roer
Nicole
N
Institute for Research in Extramural Medicine, VU University Medical Center, Amsterdam, The Netherlands. n.vanderroer@vumc.nl
van Tulder
Maurits W
MW
Barendse
Johanna M
JM
van Mechelen
Willem
W
Franken
Willemien K
WK
Ooms
Arjan C
AC
de Vet
Henrica C W
HC
D000041:Absenteeism; D000208:Acute Disease; D001416:Back Pain / Q000534:rehabilitation*; D032763:Behavior Control / Q000379:methods; D002908:Chronic Disease; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D019317:Evidence-Based Medicine / Q000191:economics / Q000379:methods; D005081:Exercise Therapy / Q000191:economics* / Q000193:education*; D015438:Health Behavior; D006266:Health Education / Q000191:economics*; D006801:Humans; D009426:Netherlands; D026741:Physical Therapy Modalities / Q000191:economics* / Q000592:standards; D017410:Practice Guidelines as Topic; D015397:Program Evaluation; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D016896:Treatment Outcome