A Randomized Controlled Crossover Study to Determine the Effectiveness of Peri-Neural Electrical Dry Needling (PNED) vs. Standard Care for the Treatment of Patients With Migraine Headaches
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Neck disability index scale
研究概览
简要总结
This study seeks to determine the effectiveness of a specific treatment protocol using dry needling with perineural electrical stimulation in comparison to standard treatment in physical therapy for patients with migraine headaches. This will be a randomized cross-over study in which participants will be in the first arm of the study, have a washout period, then cross over to the other arm of the study.
详细描述
From current understanding of migraine pathophysiology, the investigators know that it involves excitability of the trigeminovascular system. Intercranial vasculature containing nociceptor innervation consists of unmyelinated (c-fibers) and thinly myelinated (a-delta fibers ) axons which hold vasoactive neuropeptides including substance P and (CGRP) calcitonin gene related peptide. When a migraine occurs, there is a cortical spreading depolarization, which on a molecular level involves a release of ATP, glutamate, potassium, hydrogen ions, glia or vascular cells, and CGRP and nitric oxide by activated perivascular nerves. These substances, including CGRP diffuse to come in contact with nociceptors causing neurogenic inflammation (vasodilation), thus propagating a headache.
Electrical perineural dry needling causes the release of substance-P and CGRG predominantly from non-neural structures, facilitating a negative feedback loop to neural and neuroactive components of the target tissue. This causes a lowering of the levels of CGRP which in turn decreases the inflammatory component thought to play a role in migraine headaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participant will be masked to which treatment arm they are in. The outcome assessor will be masked to which treatment arm the participant was in.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women age 18 to 100 years old
- •Acute or chronic manifestation of migraine headaches or prior diagnosis of migraine headache.
- •Numeric pain rating of 3/10 (where 0= no pain and 10= worst pain)
排除标准
- •History of epilepsy
- •Needle-phobia
- •Unstable psychological status
- •Compromised immune system
- •Metallic allergy
- •Having not eaten within the past 3 hours
- •Inability to lie in prone, or side-lying
- •Pregnant or trying to become pregnant
- •Inability to consent or understand English.
- •Prisoners
结局指标
主要结局
Change in Neck disability index scale
时间窗: 1-6 days
A functional status scale ranging from 0% to 100% (0%= no activity limitation, 100% =complete activity limitation). Participants will be assessed immediately before and after treatment. Participants will be assessed 2 days per week with a minimum of 1 day between treatment days.
Change in numeric pain rating scale
时间窗: 1-6 days
Self reported pain intensity immediately before and after treatment using a numeric pain rating scale from 0 to 10 (0 = no pain and 10 = the worst pain). Participants will be assessed 2 days per week with a minimum of 1 day between treatment days.
次要结局
- Trends with use of perineural electrical dry needling with or without CGRP antagonist drugs.(following 4 weeks of treatment in the standard care plus perineural electrical dry needling arm.)
研究者
Joseph Tepp
Principal Investigator
Wheaton Franciscan Healthcare