Chiropractic Care for Episodic Migraine

发作性偏头痛的脊椎按摩疗法

• 批准号: 10576442
• 负责人: PAMELA M. RIST
• 金额: $ 64.58万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10576442
• 关键词: Academic Medical Centers; Address; Adherence; Adult; Agreement; Attention; Boston; Caring; Chiropractor; Chronic; Clinic; Clinical; Clinical Trials; Complex; Data Collection; Data Reporting; Development; Education; Effectiveness; Exercise; Foundations; Frequencies; Functional disorder; Future; Goals; Headache; Headache Disorders; Health education; High Prevalence; Individual; Infrastructure; Institutional Review Boards; Integrative Therapy; Intervention; Jaw; Knowledge; Medical; Medical center; Meta-Analysis; Methods; Migraine; Modeling; Muscle Tension; Musculoskeletal; National Center for Complementary and Integrative Health; Neck; Neck Pain; Outcome; Pain; Pain intensity; Participant; Patients; Pharmaceutical Preparations; Pilot Projects; Population; Posture; Preparation; Procedures; Protocols documentation; Randomized; Reporting; Reproducibility; Risk; Running; Severities; Site; Spinal Manipulation; Stretching; Symptoms; Techniques; Testing; Training; Translational Research; Visit; Woman; arm; chiropracty; chronic pain management; comorbidity; data harmonization; data management; data sharing; design; disability; disability burden; effectiveness evaluation; evidence base; expectation; experience; follow-up; interest; joint mobilization; meetings; men; migraine treatment; multi-component intervention; multi-site trial; multimodality; pragmatic trial; programs; randomized, clinical trials; recruit; side effect; study population; treatment as usual; virtual; years lived with disability

Project Summary/Abstract Migraine, a chronic intermittent headache disorder, ranks in the top five causes for years lived with disability. Due to the high disability burden associated with migraine, individuals who experience migraine often seek treatments to reduce the frequency and severity of their attacks and often express interest in non- pharmacologic and integrative approaches. One promising treatment may be chiropractic care due to the co- morbidity of migraine and musculoskeletal complaints. We recently completed a pilot single-site multimodal randomized clinical trial among 61 adult women with episodic migraine evaluating chiropractic care (CC) (10 visits over 14 weeks) and enhanced usual care (EUC) versus EUC alone on migraine frequency, severity, duration, and medication use. Recruitment, retention, and adherence to our study protocols were demonstrated to be feasible and preliminary clinical outcomes were promising. Our long-term goal is to conduct a multi-site large-scale fully powered trial evaluating the effectiveness of a validated multimodal chiropractic care intervention to reduce migraine frequency, severity, and disability. However, several important knowledge gaps remain which need to be addressed before undertaking a large- scale study. We need to: 1) recruit and train teams of chiropractors from established chiropractic care clinics, refine our interventions, and assess fidelity of intervention protocols; 2) establish infrastructure in preparation for a multi-site trial including coordinated institutional review board oversight, data sharing agreements, as well as harmonized data collection and reporting procedures across sites; and 3) refine recruitment and retention procedures across multiple settings, and to other groups, particularly men, who were not included in our pilot study. To help inform the design of a large-scale trial with both pragmatic and explanatory features, we propose to conduct a two-arm pilot randomized attention-controlled trial at two sites which are representative of sites to be included in the future large-scale trial. We will recruit and randomize 60 individuals (30 per site) to either 1) 14 visits of CC (6 visits of CC over 3 weeks followed by 8 visits of CC over 12 weeks); or 2) 14 sessions of headache health education (15-minute 1:1 virtual sessions focused on pre-defined migraine- specific topics) – both added to usual medical care. This study will allow us to address the following aims: 1) To train a team of chiropractors from established clinics within two academic medical centers with existing partnerships with headache programs, refine our intervention, and assess fidelity of intervention protocols; 2) To optimize data collection, data management, and reporting procedures across sites and establish the infrastructure needed for a large-scale trial; 3) To assess the feasibility of recruitment, retention, and adherence across multiple study sites; 4) To assess participant expectations and treatment experience.

项目总结/摘要 偏头痛是一种慢性间歇性头痛疾病，多年来一直排在五大病因之列。 残疾。由于与偏头痛相关的高残疾负担，经历偏头痛的个体经常 寻求治疗，以减少他们的攻击的频率和严重程度，并经常表示感兴趣的非- 药理学和综合方法。一个有前途的治疗可能是脊椎按摩护理，由于共同的， 偏头痛和肌肉骨骼疾病的发病率。我们最近完成了一个试点单站点多式联运 在61名患有发作性偏头痛的成年女性中进行的一项随机临床试验，评估了脊椎指压治疗（CC）（10 访视超过14周）和加强常规护理（EUC）对比单独EUC对偏头痛频率，严重程度， 持续时间和药物使用。招募、保留和遵守我们的研究方案 证明是可行的，初步临床结果是有希望的。 我们的长期目标是进行一项多中心、大规模的充分动力试验， 一个有效的多模式脊椎按摩护理干预，以减少偏头痛的频率，严重程度和残疾。 然而，在开展大规模的工作之前，仍有一些重要的知识差距需要解决， 规模研究我们需要：1）从现有的脊椎治疗诊所招募和培训脊椎治疗师团队， 完善我们的干预措施，并评估干预方案的保真度; 2）建立准备中的基础设施 对于多中心试验，包括协调的机构审查委员会监督、数据共享协议，以及 协调各研究中心的数据收集和报告程序;以及3）完善招募和保留 在多个环境中的程序，以及其他群体，特别是男性，他们没有包括在我们的试点中， study. 为了帮助通知设计一个既实用又有解释性的大规模试验，我们 建议在两个代表性研究中心进行一项两组初步随机注意力控制试验， 将纳入未来大规模试验的地点。我们将招募并随机分配60名受试者（每个研究中心30名）， 1）14次CC访视（3周内6次CC访视，随后12周内8次CC访视）;或2）14次 头痛健康教育课程（15分钟的1：1虚拟课程，重点是预定义的偏头痛， 具体主题）-两者都加到常规医疗护理中。这项研究将使我们能够实现以下目标：1） 从两个学术医疗中心的现有诊所中培训脊医团队， 与头痛项目合作，完善我们的干预措施，并评估干预方案的保真度; 2） 优化各研究中心的数据收集、数据管理和报告程序，并建立 大规模试验所需的基础设施; 3）评估招募、保留和 多个研究中心的依从性; 4）评估参与者的期望和治疗经验。