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

描述（由申请人提供）：已经发表了许多手工治疗慢性颈部疼痛的临床试验。最大数量的试验将脊椎推拿作为主要疗法。没有临床试验的脊椎操作慢性颈部疼痛，无论是单一或多重干预会话，采用了一个有效的手动假对照组。因此，不可能将积极治疗因素与非特异性影响分开，以提高这些程序的护理质量和能力。这让人们对这些研究的结论产生了质疑。采用假/安慰剂对照组的能力将澄清可归因治疗效果的大小，并授权项目培训提供者和优化临床结果。我们打算应用最近验证的新型假颈椎操作程序（Vernon et al., 2011），在涉及1)多个操作人员，2)多个治疗疗程，3)操作人员高级培训模式的情况下，由一名操作人员对慢性颈部疼痛进行单一治疗干预。主要的研究问题是“假颈椎手法的纵向效度是什么？”我们打算确定1)这些程序对受试者分组注册的影响，以及在与常规护理事件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)操作者能否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对治疗期望水平的影响。这项研究的结果有很大的潜力，有助于优化设计未来的临床试验的手法和其他手法治疗颈部疼痛。这将改善这些治疗的证据基础。这将提高我们对这些治疗的获益风险比的认识，从而改善慢性颈部疼痛患者的护理。

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.