Dose-Response of Manipulation for Cervicogenic Headache

描述（由申请人提供）：有许多研究支持脊椎推拿治疗颈源性头痛（CGH）的疗效，脊椎推拿治疗是指压治疗的标志性疗法。然而，还没有大型试验来确定治疗次数，以优化护理的有效性和成本效益。我们的试点研究是第一个研究脊椎操作治疗次数（剂量）与CGH缓解之间的剂量-反应关系的试验。我们研究的目的是确定脊医为CGH提供的脊椎推拿的剂量反应和成本效益。为了实现这一目标，西部州立脊椎医学学院和西北健康科学大学将进行一项为期5年的多中心随机试验。研究方案的设计是为了控制注意力和手的放置。共有256名参与者将被随机分为4个治疗组（n = 64/组）。所有参与者将参加18次按摩，每周3次，持续6周。所有参与者将在每次访问中接受治疗。剂量水平将为0、6、12或18次操作或轻按摩替代。主要的具体目的是确定脊医为慢性CGH患者提供的脊椎推拿治疗次数对临床结果和客观物理测量的影响。主要结果是CGH疼痛和数量。结果将在基线、6、12、18、24、39和52周进行评估。第二个具体的目的是确定成本-效益和成本-效用的脊椎推拿治疗的护理慢性CGH的数量。第三个具体目标是使用定量和定性方法评估预期对结果的影响。这项研究意义重大，因为它将是第一个全面研究脊椎推拿治疗头痛的最佳剂量和成本效益的试验，这是公众健康的一个重要问题。它将提供高质量的科学证据，为临床实践、第三方付款人报销以及未来慢性头痛试验中使用的脊椎指压治疗计划提供循证治疗方案。该研究将在控制/监测医患接触方面具有创新性，使用为随机试验开发的协议，在参与者/提供者盲法不可行时。一个定性的组成部分也将增加洞察病人的期望与结果的关系。长期目标是开展基于最佳护理的研究，包括疗效和比较效果的III期试验。

DESCRIPTION (provided by applicant): There have been a number of studies supporting the efficacy of spinal manipulation, the signature therapy of chiropractic care, for cervicogenic headache (CGH). Yet, there have been no large trials to identify the number of treatment visits to optimize effectiveness and cost-effectiveness of care. Our pilot studies were the first trials to investigate a dose-response relationship between the number of treatments with spinal manipulation (dose) and relief of CGH. The purpose of our study is to determine dose-response and cost-effectiveness of spinal manipulation provided by chiropractors for CGH. To accomplish this goal, Western States Chiropractic College and Northwestern Health Sciences University will conduct a 5-year multicenter randomized trial. The study protocol is designed to control attention and the laying on of hands. A total of 256 participants will be randomized to 4 treatment groups (n = 64/group). All participants will attend 18 sessions with a chiropractor: 3 visits per week for 6 weeks. All participants will receive treatment at each visit. The dose levels will be 0, 6, 12, or 18 sessions for manipulation or a light massage alternative. The primary specific aim is to determine the effect of the number of spinal manipulation treatments provided by a chiropractor for the care of chronic CGH on clinical outcomes and objective physical measures. The primary outcomes will be CGH pain and number. Outcomes will be evaluated at baseline, 6, 12, 18, 24, 39, and 52 weeks. The secondary specific aim is to determine the cost-effectiveness and cost-utility of the number of spinal manipulation treatments for the care of chronic CGH. The tertiary specific aim is to assess effects of expectations on outcomes using quantitative and qualitative methods. The study will be significant in that it will be the first fully powered trial to investigate optimal dose and cost- effectiveness of spinal manipulation for the care of headache, an important concern for the health of the public. It will provide high quality scientific evidence that will inform evidence-based treatment protocols for clinical practice, third-party payer reimbursement, and schedules of chiropractic care used in future trials on chronic headache. The study will be innovative in controlling/monitoring the doctor-patient encounter, using a protocol developed for randomized trials where participant/provider blinding is not feasible. A qualitative component will also add insight into the relationship of patient expectations with outcomes. The long-term goal is to conduct studies based on optimal care including a phase III trial of efficacy and comparative effectiveness.