Dose-Response of Manipulation for Cervicogenic Headache

描述（由申请人提供）：已经有许多研究支持脊柱推拿的疗效，脊椎按摩疗法的签名治疗颈源性头痛（CGH）。然而，还没有大型试验来确定治疗访问的数量，以优化护理的有效性和成本效益。我们的初步研究是第一个研究脊柱推拿治疗次数（剂量）与CGH缓解之间的剂量反应关系的试验。本研究的目的是确定剂量反应和成本效益的脊椎推拿提供的脊医CGH。为了实现这一目标，西方国家脊椎按摩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。 研究方案旨在控制注意力和双手的放置。共256例受试者将随机分配至4个治疗组（n = 64/组）。所有参与者将参加18个会议与脊椎按摩师：每周3次访问，为期6周。所有受试者将在每次访视时接受治疗。剂量水平为0、6、12或18次，用于操作或轻度按摩替代。 主要的具体目的是确定脊椎推拿治疗的数量提供的脊椎按摩师的慢性CGH的临床结果和客观的物理措施的照顾的效果。主要结局为CGH疼痛和数量。将在基线、第6、12、18、24、39和52周评价结局。第二个具体目标是确定成本效益和成本效用的脊柱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。 这项研究将是重要的，因为它将是第一个充分的动力试验，以调查最佳剂量和成本效益的脊柱推拿治疗头痛，一个重要的关注公众的健康。它将提供高质量的科学证据，为临床实践提供循证治疗方案，第三方付款人报销以及未来慢性头痛试验中使用的脊椎按摩治疗计划。该研究将在控制/监测医患接触方面具有创新性，使用为参与者/提供者盲法不可行的随机试验开发的方案。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。长期目标是进行基于最佳护理的研究，包括疗效和比较有效性的III期试验。 公共卫生相关性：本研究的目的是确定最佳利用脊椎按摩师提供的头痛，一个普遍的和昂贵的健康问题。研究结果可用于患者，提供者和支付者的医疗保健决策中的社会利益。

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. PUBLIC HEALTH RELEVANCE: This study aims to determine optimal utilization of spinal manipulation provided by chiropractors for headache, a widespread and costly health problem. Findings could be used to the benefit of society in healthcare decision making by patients, providers, and payers.