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7 week baseline for Migraine

N/A

Recruiting

Led By Thomas Perreault, DPT

Research Sponsored by Thomas W. Perreault, PT

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial will look at whether intramuscular electrical stimulation can reduce frequency and intensity of headaches in people with chronic migraine. Participants will be their own control and track their headaches before and after treatment.

Who is the study for?

This trial is for individuals who have been experiencing chronic migraines for at least six months. Participants should have trigger points in specific neck muscles that, when stimulated, reproduce their headache symptoms. It's not suitable for those who don't meet the International Headache Society criteria or lack these particular trigger points.Check my eligibility

What is being tested?

The study tests if intramuscular electrical stimulation can reduce headache frequency and intensity in migraine sufferers. Patients will use dry needling combined with electrical currents on muscle trigger points and track their headaches using an electronic diary.See study design

What are the potential side effects?

Potential side effects may include discomfort at needle insertion sites, muscle soreness after treatment, minor bleeding or bruising where needles are placed, and temporary increase in headache pain following the procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Headache Frequency

Secondary outcome measures

Headache Impact Test-6 (HIT-6)

Migraine Disability Assessment Test (MIDAS)

Other outcome measures

Numeric Pain Rating Scale

Pressure pain threshold

Trial Design

4Treatment groups

Experimental Treatment

Group I: 7 week baselineExperimental Treatment1 Intervention

Randomization to the fourth tier will include 7 weeks (49 days) of baseline measure, followed by 5 weeks of treatment and symptom monitoring

Group II: 6 week baselineExperimental Treatment1 Intervention

Randomization to the third tier will include 6 weeks (42 days) of baseline measures, followed by 5 weeks of treatment and symptom monitoring (phase B)

Group III: 5 week baselineExperimental Treatment1 Intervention

Randomization to the second tier will include 5 weeks (35 days) of baseline measures (phase A), followed by 5 weeks of treatment and symptom monitoring (phase B)

Group IV: 4 week baselineExperimental Treatment1 Intervention

Randomization to the first tier will include 4 weeks (28 days) of baseline measures (phase A), followed by 5 weeks of treatment and symptom monitoring (phase B)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Thomas W. Perreault, PTLead Sponsor

Thomas Perreault, DPTPrincipal InvestigatorMass General Brigham

Media Library

Dry Needling and intramuscular electrical stimulation to trigger points (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05893914 — N/A

Migraine Research Study Groups: 7 week baseline, 4 week baseline, 5 week baseline, 6 week baseline

Migraine Clinical Trial 2023: Dry Needling and intramuscular electrical stimulation to trigger points Highlights & Side Effects. Trial Name: NCT05893914 — N/A

Dry Needling and intramuscular electrical stimulation to trigger points (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05893914 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any persons aged 18 or above being admitted into this research?

"The requirements for this medical trial ask that patients be aged between 18 and 65. For those outside of this range, there are 39 trials available to underage individuals and 119 specifically targeting seniors."

Answered by AI

Am I eligible to partake in this investigation?

"This trial requires applicants to have a diagnosis of migraine and be within the age range of 18-65. A total of 4 participants are needed for this clinical study."

Answered by AI

Is this research recruiting participants at present?

"According to the records kept on clinicaltrials.gov, this specific trial is no longer recruiting participants. It was initially posted July 1st 2023 and received its last edit June 7th 2023; yet, there are 177 other trials that currently seek volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intramuscular Electrical Stimulation for the Treatment of Trigger Points in Patients With Migraine

Thomas W. Perreault, PT 2023. "Intramuscular Electrical Stimulation for the Treatment of Trigger Points in Patients With Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05893914.

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