Dose-Response of Manipulation for Cervicogenic Headache

颈源性头痛手法治疗的剂量反应

• 批准号: 8496496
• 负责人: Gert Bronfort
• 金额: $ 67.39万
• 依托单位: UNIVERSITY OF WESTERN STATES
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8496496
• 关键词: Affect; Attention; Blinded; Caring; Cervical; Cervicogenic Headaches; Chest; Chiropractor; Chronic; Chronic Care; Chronic Headaches; Clinical; Decision Making; Dose; Effectiveness; Ensure; Equation; Equilibrium; Equipoise; Evidence based treatment; Facilities and Administrative Costs; Future; Goals; Hand; Headache; Health; Health Personnel; Health Sciences; Healthcare; Intervention; Interview; Investigation; Laying-on-of-Hands; Light; Massage; Measures; Modeling; Monitor; Motion; National Center for Complementary and Alternative Medicine; Neck Pain; Outcome; Pain; Participant; Patients; Pharmaceutical Preparations; Phase III Clinical Trials; Pilot Projects; Placebo Effect; Protocols documentation; Provider; Public Health; Qualitative Methods; Quality of life; Randomized; Recruitment Activity; Relative (related person); Research; Schedule; Site; Societies; Spinal Manipulation; Third-Party Payer; Time; Treatment Cost; Treatment Protocols; Universities; Vertebral column; Visit; base; chiropracty; clinical practice; college; comparative effectiveness; cost; cost effectiveness; design; disability; expectation; experience; indexing; innovation; insight; intervention effect; joint function; patient expectation; pilot trial; primary outcome; randomized trial; response

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.

描述（由申请人提供）：已有许多研究支持脊柱操纵的功效，脊椎治疗的签名治疗，用于宫颈癌头痛（CGH）。但是，没有进行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。我们的试点研究是第一个研究脊柱操纵（剂量）的治疗数量与CGH释放之间的剂量反应关系的试验。我们研究的目的是确定脊椎治疗师为CGH提供的脊柱操纵的剂量反应和成本效益。为了实现这一目标，西方国家脊骨疗法学院和西北健康科学大学将进行5年的多中心随机试验。 研究方案旨在控制注意力和手上的伸出。共有256名参与者将被随机分为4个治疗组（n = 64/组）。所有参与者将与脊椎按摩师一起参加18次会议：每周3次访问6周。所有参与者每次访问都将接受治疗。剂量水平将为操纵或轻按按摩替代方案0、6、12或18个课程。 主要目的是确定脊椎治疗者为护理慢性CGH提供对临床结果和客观物理测量的脊柱操纵治疗数量的影响。主要结果将是CGH疼痛和数量。结果将在基线，6、12、18、24、39和52周时进行评估。次要的特定目的是确定用于护理慢性CGH的脊柱操纵治疗数量的成本效益和成本效用。 第三特定的目的是使用定量和定性方法评估期望对结果的影响。 这项研究将是重要的，因为它将是首次调查脊柱操纵以护理头痛的最佳剂量和成本效益的全力试验，这是公众健康的重要问题。它将提供高质量的科学证据，这些证据将为临床实践，第三方付款人报销以及未来关于慢性头痛试验中使用的脊椎治疗时间表提供基于证据的治疗方案。这项研究将使用用于随机试验的协议来控制/监测医生遭遇的遭遇，该方案是参与者/提供者盲目不可行的。定性组成部分还将洞悉患者期望与结果的关系。长期目标是基于最佳护理进行研究，包括疗效和比较有效性的III期试验。