Clinical trial NCT04252391: Peri-neural Electrical Dry Needling Migraine Treatment Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine Headache
Lead sponsor: Wheaton Franciscan Healthcare
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized controlled cross-over study
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in numeric pain rating scale
timeFrame: 1-6 days
measure: Change in Neck disability index scale
timeFrame: 1-6 days
Secondary outcomes:
measure: Trends with use of perineural electrical dry needling with or without CGRP antagonist drugs.
timeFrame: following 4 weeks of treatment in the standard care plus perineural electrical dry needling arm.
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Ascension Rehabilitation Services
state: Wisconsin
Study officials:
affiliation: Ascension Healthcare
name: Joe Tepp, DPT
role: PRINCIPAL_INVESTIGATOR
References: