Generalizing a valid control procedure for cervical manipulation to a multiple op

点击翻译按钮获取中文摘要

DESCRIPTION (provided by applicant): A number of clinical trials of manual therapies for chronic neck pain have been published. The largest number of trials involves spinal manipulation as the primary therapy. No clinical trial of spinal manipulation for chronic neck pain, either of a single or multiple intervention sessions, has employed a validated manual sham control group. As a result, it is not possible to separate active treatment factors from non-specific effects in order to improve the quality and competency of care with these procedures. This calls the conclusions of these studies into question. The ability to employ sham/placebo comparison groups would clarify the magnitude of the attributable therapeutic effect and empower programs to train providers and optimize clinical results. We intend to apply a recently validated novel sham cervical spinal manipulation procedure (Vernon et al., 2011) for a single treatment intervention by one operator for chronic neck pain to circumstances involving 1) multiple operators, 2) multiple treatment sessions and, 3) an advanced mode of training of operators. The primary research question is "what is the longitudinal validity of the sham cervical manipulation procedure?" We intend to determine 1) what the effects of these procedures are on subjects' registration of group allocation and on clinical measures of pain and disability over time intervals consistent with episodes of care in common practice, and, 2) if operators can maintain high levels of treatment fidelity throughout the study. The influence of subjects' levels of treatment expectation will also be explored. The findings of this study have a strong potential to contribute to the optimal design of future clinical trials of manipulative and other manual therapies for neck pain. This should improve the evidence base for these treatments. This should improve our knowledge as to the benefit-to-risk ratio for these treatments, thereby improving the care of patients with chronic neck pain.