Chiropractic Care for Episodic Migraine

发作性偏头痛的脊椎按摩疗法

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要偏头痛是一种慢性间歇性头痛疾病，是多年来患有偏头痛的前五位原因之一。由于与偏头痛相关的高残疾负担，经常患有偏头痛的人。寻求治疗以减少发作的频率和严重程度，并经常表达对非治疗的兴趣一种有前途的治疗方法可能是脊椎按摩治疗，因为我们最近完成了一项单站点多模式试点。随机临床试验在 61 名患有阵发性偏头痛的成年女性中进行，评估脊椎按摩治疗 (CC) (10 14 周以上就诊）和强化常规护理 (EUC) 与单独使用 EUC 相比，在偏头痛频率、严重程度、招募、保留和遵守我们的研究方案。被证明是可行的，初步的临床结果是有希望的。我们的长期目标是进行多站点大规模全动力试验，评估有效性一种经过验证的多模式脊椎按摩治疗干预措施，可减少偏头痛的频率、严重程度和残疾。然而，在进行大规模研究之前，仍然存在一些重要的知识差距，需要解决这些差距我们需要：1）从现有的脊椎按摩治疗诊所招募和培训脊椎按摩师团队，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；进行多地点试验，包括协调机构审查委员会的监督、数据共享协议以及跨站点的统一数据收集和报告程序；以及 3) 完善招聘和保留跨多种环境以及其他群体（特别是未包括在我们试点中的男性）的程序学习。为了帮助设计具有实用性和解释性特征的大规模试验，我们提议在两个具有代表性的地点进行双臂试验随机注意力控制试验我们将招募并随机分配 60 个人（每个中心 30 人）来参与未来的大规模试验。 1) 14 次 CC 就诊（3 周内 6 次 CC 就诊，随后 12 周内 8 次 CC 就诊）或 2) 14 次；头痛健康教育课程（15 分钟 1:1 虚拟课程，重点关注预先定义的偏头痛）特定主题）——两者都添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）培训来自两个学术医疗中心现有诊所的脊椎按摩师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) 优化跨站点的数据收集、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、保留和保留的可行性多个研究中心的依从性；4) 评估参与者的期望和治疗经验。