Peri-neural Electrical Dry Needling Migraine Treatment Study

Wheaton Franciscan Healthcare

Status: Unknown

Conditions: Migraine Headache

Treatments: Procedure: Standard Care; Procedure: Perineural electrical dry needling

Study type: Interventional

Funder types: Other

Identifiers

NCT04252391

WheatonFH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Standard care

Active Comparator group

Description:

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 .

Treatment:

Procedure: Standard Care

standard care with perineural electrical dry needling.

Active Comparator group

Description:

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.

Treatment:

Procedure: Perineural electrical dry needling