Migraine HeadacheNCT04252391
Peri-neural Electrical Dry Needling Migraine Treatment Study
A study testing Perineural electrical dry needling in people with Migraine Headache, run by Wheaton Franciscan Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Headache
- What is being tested?
- Perineural electrical dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- History of epilepsy
- Needle-phobia
- Unstable psychological status
- Compromised immune system
- Metallic allergy
- Having not eaten within the past 3 hours
Show all 10Show fewer
- Inability to lie in prone, or side-lying
- Pregnant or trying to become pregnant
- Inability to consent or understand English.
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ascension Rehabilitation Services
Milwaukee, Wisconsin, 53221
Joe Tepp, DPT, 414-389-3023, joseph.tepp@ascension.org
Joe Tepp, DPT
About this 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
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.
Read the 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.
- Conditions
- Migraine Headache
- Being tested
- Perineural electrical dry needling, Standard Care
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineural electrical dry needlingProcedure or surgery
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.
Standard CareProcedure or surgery
cervical or thoracic manipulation or mobilization, muscle stretching, muscle strengthening, electrical trigger point dry needling , soft tissue release and prescribed therapeutic exercises .
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | 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 . Receives: Procedure: Standard Care |
| standard care with perineural electrical dry needling. | Active comparator | 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. Receives: Procedure: Perineural electrical dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-6 days
Secondary outcomes (1)
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.
Measured: following 4 weeks of treatment in the standard care plus perineural electrical dry needling arm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start18 Feb 2020
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled cross-over study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wheaton Franciscan Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Tepp, Wheaton Franciscan Healthcare
- Investigators
- Joe Tepp, DPT, Principal investigator, Ascension Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252391
- Sponsor's protocol ID
- WheatonFH
- Status last verified
- May 2022
- First submitted
- 29 Jan 2020
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04252391
- Acronym / sponsor ID
- WheatonFH
- Conditions
- Migraine Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Wheaton Franciscan HealthcareUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled cross-over study
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Procedure: Standard CareStandard 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 comparator | Procedure: Perineural electrical dry needlingThis 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- History of epilepsy
- Needle-phobia
- Unstable psychological status
- Compromised immune system
- Metallic allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineural electrical dry needlingStandard 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. | Procedure or surgery | standard care with perineural electrical dry needling. |
| Standard Carecervical or thoracic manipulation or mobilization, muscle stretching, muscle strengthening, electrical trigger point dry needling , soft tissue release and prescribed therapeutic exercises . | Procedure or surgery | Standard care |
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe Tepp, DPT principal investigator
Ascension Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineural electrical dry needling in people with Migraine Headache, run by Wheaton Franciscan Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jackie Kirchen, MS, CIP (414-465-3134, jackie.kirchen@ascension.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in numeric pain rating scale (time frame: 1-6 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022; AzTrials last refreshed its copy on 3 Nov 2026.