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Peri-neural Electrical Dry Needling Migraine Treatment Study

Primary Purpose

Migraine Headache

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perineural electrical dry needling
Standard Care
Sponsored by
Wheaton Franciscan Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Headache

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Ascension Rehabilitation ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard care

standard care with perineural electrical dry needling.

Arm 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 .

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.

Outcomes

Primary Outcome Measures

Change in numeric pain rating scale
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.
Change in Neck disability index scale
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

Trends with use of perineural electrical dry needling with or without CGRP antagonist drugs.
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.

Full Information

First Posted
January 29, 2020
Last Updated
May 6, 2022
Sponsor
Wheaton Franciscan Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT04252391
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wheaton Franciscan Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized controlled cross-over study
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
Active Comparator
Arm 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 .
Arm Title
standard care with perineural electrical dry needling.
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Perineural electrical dry needling
Intervention Description
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
Intervention Name(s)
Standard Care
Intervention Description
cervical or thoracic manipulation or mobilization, muscle stretching, muscle strengthening, electrical trigger point dry needling , soft tissue release and prescribed therapeutic exercises .
Primary Outcome Measure Information:
Title
Change in numeric pain rating scale
Description
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.
Time Frame
1-6 days
Title
Change in Neck disability index scale
Description
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.
Time Frame
1-6 days
Secondary Outcome Measure Information:
Title
Trends with use of perineural electrical dry needling with or without CGRP antagonist drugs.
Description
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.
Time Frame
following 4 weeks of treatment in the standard care plus perineural electrical dry needling arm.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jackie Kirchen, MS, CIP
Phone
414-465-3134
Email
jackie.kirchen@ascension.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe Tepp, DPT
Organizational Affiliation
Ascension Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ascension Rehabilitation Services
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53221
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joe Tepp, DPT
Phone
414-389-3023
Email
joseph.tepp@ascension.org
First Name & Middle Initial & Last Name & Degree
Joe Tepp, DPT

12. IPD Sharing Statement

Plan to Share IPD
No

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Peri-neural Electrical Dry Needling Migraine Treatment Study

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