METHODS: Six patients participated in this 6-month study, 5 of whom were female. One female was braced. The mean age of these patients was 14 years, and the mean Cobb angle was 22.2 degrees. The study design was a randomized controlled clinical trial with two independent and blinded observers. Three patients were treated by standard medical care (observation or brace treatment), two were treated with standard medical care plus chiropractic manipulation, and one was treated with standard medical care plus sham manipulation. The primary outcome measure was Cobb, and the psychosocial measure was Scoliosis Quality of Life Index.
RESULTS: Orthopedic surgeons and chiropractors were easily recruited and worked cooperatively throughout the trial. Patient recruitment and compliance was good. Chiropractic treatments were safely employed, and research protocols were successful.
CONCLUSIONS: Overall, our pilot study showed the viability for a larger randomized trial. This pilot confirms the strength of existing protocols with amendments for use in a full randomized controlled trial.
Trial Registration This trial has been assigned an international standard randomized controlled trial number by Current Controlled Trials, Ltd. (http://www.controlled-trials.com/isrctn/). The number is ISRCTN41221647.
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