Peri-neural Electrical Dry Needling Migraine Treatment Study

  • STATUS
    Recruiting
  • End date
    Apr 12, 2023
  • participants needed
    30
  • sponsor
    Wheaton Franciscan Healthcare
Updated on 12 May 2022
headache
Accepts healthy volunteers

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.

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.

Details
Condition Migraine Headache
Treatment Standard Care, Perineural electrical dry needling
Clinical Study IdentifierNCT04252391
SponsorWheaton Franciscan Healthcare
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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