Peri-neural Electrical Dry Needling Migraine Treatment Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-18

Study Completion Date

2023-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Migraine Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized controlled cross-over study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The participant will be masked to which treatment arm they are in. The outcome assessor will be masked to which treatment arm the participant was in.

Study Groups

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Standard care

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 .

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type PROCEDURE

cervical or thoracic manipulation or mobilization, muscle stretching, muscle strengthening, electrical trigger point dry needling , soft tissue release and prescribed therapeutic exercises .

standard care with perineural electrical dry needling.

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.

Group Type ACTIVE_COMPARATOR

Perineural electrical dry needling

Intervention Type PROCEDURE

Standard care plus use of perineural electrical dry needling involving use of a monofilament needle of 15 or 30 mm length, 0.25 mm diameter will be placed utilizing the therapist's dominant hand following palpation of correct needle location. An electrical stimulation unit will be used to conduct an electrical impulse. The unit used will be an ES-130 by ITO (Japan) using a DC 9V battery producing an asymmetrical biphasic waveform. The unit has 6 available leads with alligator clamps, connecting to needle shafts. Parameters of PNED will include intensity set at a strong yet comfortable setting according to patient feedback. Treatment duration will be 15 minutes. Treatment frequency will be set to Medium at level 8 (80 Hz). Parameters will be set to elicit a sensory response.

Interventions

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Perineural electrical dry needling

Standard care plus use of perineural electrical dry needling involving use of a monofilament needle of 15 or 30 mm length, 0.25 mm diameter will be placed utilizing the therapist's dominant hand following palpation of correct needle location. An electrical stimulation unit will be used to conduct an electrical impulse. The unit used will be an ES-130 by ITO (Japan) using a DC 9V battery producing an asymmetrical biphasic waveform. The unit has 6 available leads with alligator clamps, connecting to needle shafts. Parameters of PNED will include intensity set at a strong yet comfortable setting according to patient feedback. Treatment duration will be 15 minutes. Treatment frequency will be set to Medium at level 8 (80 Hz). Parameters will be set to elicit a sensory response.

Intervention Type PROCEDURE

Standard Care

cervical or thoracic manipulation or mobilization, muscle stretching, muscle strengthening, electrical trigger point dry needling , soft tissue release and prescribed therapeutic exercises .

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes