A randomized controlled trial of tai chi for long-term low back pain (TAI CHI): study rationale, design, and methods.
BACKGROUND
Low back pain persisting for longer than 3 months is a common and costly condition for which many current treatments have low-moderate success rates at best. Exercise is among the more successful treatments for this condition, however, the type and dosage of exercise that elicits the best results is not clearly defined. Tai chi is a gentle form of low intensity exercise that uses controlled movements in combination with relaxation techniques and is currently used as a safe form of exercise for people suffering from other chronic pain conditions such as arthritis. To date, there has been no scientific evaluation of tai chi as an intervention for people with back pain. Thus the aim of this study will be to examine the effects of a tai chi exercise program on pain and disability in people with long-term low back pain.


METHODS
The study will recruit 160 healthy individuals from the community setting to be randomised to either a tai chi intervention group or a wait-list control group. Individuals in the tai chi group will attend 2 tai chi sessions (40 minutes)/week for 8 weeks followed by 1 tai chi session/week for 2 weeks. The wait-list control will continue their usual health care practices and have the opportunity to participate in the tai chi program once they have completed the follow-up assessments. The primary outcome will be bothersomeness of back symptoms measured with a 0-10 numerical rating scale. Secondary outcomes include, self-reports of pain-related disability, health-related quality of life and global perceived effect of treatment. Statistical analysis of primary and secondary outcomes will be based on the intention to treat principle. Linear mixed models will be used to test for the effect of treatment on outcome at 10 weeks follow up. This trial has received ethics approval from The University of Sydney Human Research Ethics Committee. HREC Approval No.10452


CONCLUSIONS
This study will be the first trial in this area and the information on its effectiveness will allow patients, clinicians and treatment funders to make informed choices regarding this treatment.


BACKGROUND
This trial has been registered with Australian New Zealand Clinical Trials Registry. ACTRN12608000270314.
Hall
Amanda M
AM
The George Institute for International Health, The University of Sydney, Sydney, Australia. amandahall@george.org.au
Maher
Chris G
CG
Latimer
Jane
J
Ferreira
Manuela L
ML
Lam
Paul
P
D002986:Clinical Trials as Topic / Q000379:methods; D003362:Cost-Benefit Analysis; D003627:Data Interpretation, Statistical; D004185:Disability Evaluation; D023381:Endpoint Determination / Q000379:methods; D005081:Exercise Therapy / Q000379:methods*; D006801:Humans; D017116:Low Back Pain / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D009520:New Zealand; D017063:Outcome Assessment, Health Care / Q000379:methods; D010147:Pain Measurement / Q000379:methods; D017060:Patient Satisfaction; D011788:Quality of Life; D012064:Relaxation Therapy / Q000379:methods*; D012107:Research Design; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D026302:Tai Ji / Q000379:methods*; D016896:Treatment Outcome