Peri-neural Electrical Dry Needling Migraine Treatment Study

Last updated: May 6, 2022
Sponsor: Wheaton Franciscan Healthcare
Overall Status: Active - Recruiting

Phase

N/A

Condition

Migraine (Pediatric)

Pain (Pediatric)

Pain

Treatment

N/A

Clinical Study ID

NCT04252391
WheatonFH
  • Ages 18-100
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women age 18 to 100 years old
  • Acute or chronic manifestation of migraine headaches or prior diagnosis of migraineheadache.
  • Numeric pain rating of 3/10 (where 0= no pain and 10= worst pain)

Exclusion

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

Total Participants: 30
Study Start date:
February 18, 2020
Estimated Completion Date:
April 30, 2023

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.

Connect with a study center

  • Ascension Rehabilitation Services

    Milwaukee, Wisconsin 53221
    United States

    Active - Recruiting

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