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Peri-neural Electrical Dry Needling Migraine Treatment Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252391
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Joseph Tepp, Wheaton Franciscan Healthcare

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.

Condition or disease Intervention/treatment Phase
Migraine Headache Procedure: Perineural electrical dry needling Procedure: Standard Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized controlled cross-over study
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
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
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Active Comparator: 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 .
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 .

Active Comparator: 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.
Procedure: 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.




Primary Outcome Measures :
  1. Change in numeric pain rating scale [ Time Frame: 1-6 days ]

    Self reported pain intensity immediately before and after treatment using a numeric pain rating scale from 0 to 10 (0 = no pain and 10 = the worst pain).

    Participants will be assessed 2 days per week with a minimum of 1 day between treatment days.


  2. Change in Neck disability index scale [ Time Frame: 1-6 days ]

    A functional status scale ranging from 0% to 100% (0%= no activity limitation, 100% =complete activity limitation).

    Participants will be assessed immediately before and after treatment. Participants will be assessed 2 days per week with a minimum of 1 day between treatment days.



Secondary Outcome Measures :
  1. Trends with use of perineural electrical dry needling with or without CGRP antagonist drugs. [ Time Frame: following 4 weeks of treatment in the standard care plus perineural electrical dry needling arm. ]
    Because this is a small trial it is unlikely that we will be able to determine if migraine drugs significantly modify the effect perineural electrical dry needle treatment has on pain and the neck disability index. However we will look for any trends in interaction between perineural electrical dry needle treatment and migraine drugs using exploratory data analysis and box plot comparisons.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252391


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

Locations
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United States, Wisconsin
Ascension Rehabilitation Services Recruiting
Milwaukee, Wisconsin, United States, 53221
Contact: Joe Tepp, DPT    414-389-3023    joseph.tepp@ascension.org   
Principal Investigator: Joe Tepp, DPT         
Sponsors and Collaborators
Wheaton Franciscan Healthcare
Investigators
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Principal Investigator: Joe Tepp, DPT Ascension Healthcare
  Study Documents (Full-Text)

Documents provided by Joseph Tepp, Wheaton Franciscan Healthcare:
Informed Consent Form  [PDF] January 24, 2020


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Responsible Party: Joseph Tepp, Principal Investigator, Wheaton Franciscan Healthcare
ClinicalTrials.gov Identifier: NCT04252391    
Other Study ID Numbers: WheatonFH
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms