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

描述(申请人提供)：已经发表了一些手动疗法治疗慢性颈部疼痛的临床试验。涉及脊柱手法作为主要治疗方法的试验数量最多。没有脊柱手法治疗慢性颈痛的临床试验，无论是单次还是多次干预，都没有采用经过验证的手动假对照组。因此，不可能将积极的治疗因素从非特异性影响中分离出来，以便通过这些程序提高护理的质量和能力。这让这些研究的结论受到了质疑。使用假/安慰剂对照组的能力将澄清归因治疗效果的大小，并使培训提供者和优化临床结果的计划得以实施。我们打算将最近验证的新的假颈椎手法操作程序(Vernon等人，2011年)应用于由一个操作员对慢性颈部疼痛进行的单一治疗干预，涉及1)多个操作员，2)多个治疗疗程，以及3)操作员的高级培训模式。主要的研究问题是“假颈椎手法的纵向有效性是什么？”我们打算确定1)这些程序对受试者的分组登记以及在与常规护理事件相一致的时间间隔内对疼痛和残疾的临床测量的影响，以及，2)操作者是否能在整个研究过程中保持高水平的治疗保真度。研究还将探讨受试者的治疗期望水平的影响。这项研究的结果具有很强的潜力，有助于未来颈部疼痛手法和其他手动疗法的临床试验的优化设计。这应该会改善这些治疗的证据基础。这应该会提高我们对这些治疗的益处/风险比的了解，从而改善慢性颈痛患者的护理。

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.