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(申请人提供)：已有多项研究支持脊椎手法治疗颈源性头痛(CGH)的疗效，脊椎手法是脊椎按摩护理的标志性疗法。然而，还没有大型试验来确定治疗就诊的次数，以优化护理的有效性和成本效益。我们的先导性研究是第一次研究脊柱手法治疗次数(剂量)与CGH缓解之间的剂量-反应关系。本研究的目的是确定脊医为CGH提供的脊柱手法的剂量-反应和成本-效果。为了实现这一目标，西部州立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。学习协议的设计是为了控制注意力和放手。将256名受试者随机分为4个治疗组(n=/组)。所有参与者将与脊椎按摩师一起参加18个疗程：每周3次，为期6周。所有参与者在每次探视时都将得到治疗。剂量水平为0次、6次、12次或18次，用于手法或轻按摩替代疗法。主要的具体目的是确定脊医为治疗慢性CGH而提供的脊柱手法治疗的次数对临床结果和客观体能测量的影响。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周进行评估。第二个具体目标是确定治疗慢性CGH的脊柱手法治疗的成本效益和成本效用。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。这项研究将具有重要意义，因为它将是第一个全动力试验，以调查脊柱手法治疗头痛的最佳剂量和成本效益，头痛是公众关注的一个重要问题。它将提供高质量的科学证据，为临床实践、第三方付款人报销和未来慢性头痛试验中使用的脊椎护理时间表提供循证治疗方案。这项研究在控制/监测医患接触方面将是创新的，使用为参与者/提供者盲法不可行的随机试验开发的方案。定性部分还将增加对患者期望与结果关系的洞察。长期目标是在最佳护理的基础上进行研究，包括疗效和比较有效性的第三阶段试验。