Peri-neural Electrical Dry Needling Migraine Treatment Study
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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
February 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedMay 9, 2022
May 1, 2022
3.1 years
January 29, 2020
May 6, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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.
1-6 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.
1-6 days
Secondary Outcomes (1)
Trends with use of perineural electrical dry needling with or without CGRP antagonist drugs.
following 4 weeks of treatment in the standard care plus perineural electrical dry needling arm.
Study Arms (2)
Standard care
ACTIVE COMPARATORStandard 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 .
standard care with perineural electrical dry needling.
ACTIVE COMPARATORThis 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.
Interventions
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.
cervical or thoracic manipulation or mobilization, muscle stretching, muscle strengthening, electrical trigger point dry needling , soft tissue release and prescribed therapeutic exercises .
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ascension Rehabilitation Services
Milwaukee, Wisconsin, 53221, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joe Tepp, DPT
Ascension Healthcare
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 29, 2020
First Posted
February 5, 2020
Study Start
February 18, 2020
Primary Completion
April 1, 2023
Study Completion
April 1, 2023
Last Updated
May 9, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share