Milwaukee, Wisconsin 53221

  • Migraine Headache

Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT04252391


Primary Contact:

Principal Investigator
Joe Tepp, DPT
Ascension Healthcare

Jackie Kirchen, MS, CIP
Phone: 414-465-3134
Email: jackie.kirchen@ascension.org


Backup Contact:

N/A


Location Contact:

Milwaukee, Wisconsin 53221
United States

Joe Tepp, DPT
Phone: 414-389-3023
Email: joseph.tepp@ascension.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2022

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