PDF(Pubmed)
Abstract：
Background and Objectives: Trigger points (TrPs) are prevalent in patients with migraine headaches. Needling interventions targeting TrPs in migraine patients may reduce the intensity and frequency of headaches, yet systematic reviews reveal a lack of robust evidence. Intramuscular electrical stimulation (IMES) is a modality that delivers electrical current into muscles and TrPs, with recent studies suggesting it may amplify the therapeutic effects of dry needling peripherally and centrally. This could be advantageous for patients with migraine and symptomatic TrPs. Materials and Methods: This study will implement a multiple baseline single-case experimental design (SCED). In a clinical setting, a SCED study lends itself to conducting research with only a few patients that each serve as their own controls. In this SCED study, four participants with chronic migraine will be enrolled in a non-concurrent manner and randomized to one of four baseline measurement periods (4, 5, 6 or 7 weeks), leading to four potentially different start dates for each participant in the intervention phase. During the intervention phase, patients will receive five sessions of dry needling with IMES, one session per week for five weeks. The primary outcome measure will be headache frequency, i.e., the reduction in the number of headache days over a one-month period using electronic headache diary data from the Migraine Buddy smartphone application. Secondary outcome measures will be changes in mean migraine pain intensity using a numeric pain rating scale (NPRS), migraine disability using the Migraine Disability Assessment Test (MIDAS), the Headache Impact Test (HIT-6), and changes in selected cervical musculoskeletal impairments including pressure pain thresholds (PPTs) over TrPs, the craniocervical flexion test (CCFT), and cervical active range of motion (AROM). Primary and secondary outcome measures will be analyzed separately using both visual and statistical analyses. Results: Actively recruiting participants. This project was approved by the Mass General Brigham Institutional Review Board (protocol #2023P000931) and is registered with ClinicalTrials.gov (NCT05893914). Conclusions: This study will seek to determine the effects of a five-week intervention period of IMES to TrPs in the posterior cervical muscles of subjects with chronic migraine.
摘要：
背景和目的：触发点（TrP）在偏头痛患者中普遍存在。针对偏头痛患者的TrP进行针刺干预可能会降低头痛的强度和频率，然而，系统评价显示缺乏有力的证据。肌内电刺激（IMES）是一种将电流输送到肌肉和TrP的方式，最近的研究表明，它可能会增强外周和中央干刺的治疗效果。这对于患有偏头痛和症状性TrP的患者可能是有利的。材料和方法：本研究将实施多基线单例实验设计（SCED）。在临床环境中，一项SCED研究适合于仅对少数患者进行研究，每个患者都作为自己的对照。在这项SCED研究中，四名慢性偏头痛患者将以非并行方式登记，并随机分配到四个基线测量周期之一（4,5,6或7周），导致每个参与者在干预阶段有四个可能不同的开始日期。在干预阶段,患者将接受五次IMES干针治疗，每周一次，共五周。主要结果指标将是头痛频率，即，使用来自MigraineBuddy智能手机应用程序的电子头痛日记数据，在一个月内减少头痛天数。次要结果指标是使用数字疼痛评定量表（NPRS）的平均偏头痛疼痛强度的变化，使用偏头痛残疾评估测试（MIDAS），头痛冲击试验（HIT-6），以及选定的颈椎肌肉骨骼损伤的变化，包括与TrP相比的压力疼痛阈值（PPTs），颅颈屈曲试验（CCFT），和宫颈活动范围（AROM）。主要和次要结果测量将使用视觉和统计分析分别进行分析。结果：积极招募参与者。该项目获得了大众百翰大学机构审查委员会的批准（协议＃2023P000931），并在ClinicalTrials.gov（NCT05893914）注册。结论：这项研究将试图确定为期五周的IMES干预期对慢性偏头痛受试者颈后肌TrP的影响。
