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

将颈椎操作的有效控制程序推广到多操作

• 批准号: 8725474
• 负责人: Howard Terry Vernon
• 金额: $ 30.85万
• 依托单位: CANADIAN MEMORIAL CHIROPRACTIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8725474
• 关键词: Aftercare; Biological Markers; Caring; Cervical; Cervical Manipulation; Chronic neck pain; Clinical; Clinical Markers; Clinical Trials; Control Groups; Controlled Clinical Trials; Data; Effectiveness; Evidence based treatment; Future; Goals; Health Policy; Intervention; Interview; Journals; Knowledge; Manuals; Measures; Monitor; Neck Pain; Neurologic; Odds Ratio; Outcome; Pain; Participant; Patient Care; Patient Self-Report; Patients; Performance; Placebos; Policies; Procedures; Provider; Publishing; Randomized; Research; Site; Spinal Manipulation; Testing; Theoretical model; Therapeutic; Therapeutic Effect; Time; Training; Training Programs; Treatment Factor; Validation; Vertebral column; active method; base; blind; care episode; comparison group; design; disability; empowered; evidence based guidelines; expectation; experience; improved; knowledge of results; novel; patient expectation; programs; satisfaction; systematic review; time interval; validation studies; visual feedback

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.

描述（由申请人提供）：已经发表了许多慢性颈部疼痛手动疗法的临床试验。最大数量的试验涉及脊柱推拿作为主要疗法。没有临床试验的脊柱推拿治疗慢性颈部疼痛，无论是一个单一的或多个干预会议，已采用了一个有效的手动假对照组。因此，不可能将积极的治疗因素与非特异性效应分开，以提高这些程序的护理质量和能力。这就对这些研究的结论提出了质疑。采用假/安慰剂对照组的能力将阐明可归因的治疗效果的大小，并使项目能够培训提供者并优化临床结果。我们打算应用一种最近证实的新型假颈椎手法（弗农等人，2011年），由一名操作员对慢性颈部疼痛进行单次治疗干预，涉及1）多名操作员，2）多个治疗疗程和3）操作员培训的高级模式。主要的研究问题是“假颈椎手法操作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组分配登记以及与常规护理事件一致的时间间隔内疼痛和残疾的临床测量的影响，以及2）操作员是否可以在整个研究中保持高水平的治疗保真度。受试者的治疗期望水平的影响也将进行探讨。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动治疗颈部疼痛。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，从而改善慢性颈痛患者的护理。