Peri-neural Electrical Dry Needling Migraine Treatment Study

Not Applicable

• Conditions: Migraine Headache
• Interventions: Procedure: Standard Care; Procedure: Perineural electrical dry needling

• Registration Number: NCT04252391
• Lead Sponsor: Wheaton Franciscan Healthcare

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-02-05
• Study Start: 2020-02-18
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-09
• Primary Completion: 2023-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard care	Standard Care	Standard care will consist of standard physical therapy care which may include the following: cervical or thoracic manipulation or mobilization, muscle stretching, muscle strengthening, dry needling with or without electrical trigger point dry needling, soft tissue release and prescribed therapeutic exercises .
standard care with perineural electrical dry needling.	Perineural electrical dry needling	This arm will consist of standard care with perineural electrical dry needling, using a high frequency stimulation placed near the nerve, differing from addressing muscular trigger points. For example, a dry needle placed in the semispinalis capitus muscle along the greater occipital nerve pathway, stimulated at 80 Hz.

Primary Outcome Measures

Name	Time	Method
Change in Neck disability index scale	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	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.

Secondary Outcome Measures

Name	Time	Method
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.	Because this is a small trial it is unlikely that we will be able to determine if migraine drugs significantly modify the effect perineural electrical dry needle treatment has on pain and the neck disability index. However we will look for any trends in interaction between perineural electrical dry needle treatment and migraine drugs using exploratory data analysis and box plot comparisons.

Trial Locations

Locations (1)

Ascension Rehabilitation Services; 🇺🇸 Milwaukee, Wisconsin, United States