N/A
N=26
An Exploratory Prospective Trial of Rescue Acupuncture for the Treatment of Acute Migraine
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT02764996 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Change of Migraine Headache Pain — 16; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupuncture (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mike O'Callaghan Military Hospital
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Migraine Headache Pain |
16; 2 | — |
Summary
This will be an exploratory observational trial of rescue acupuncture for the treatment of acute migraine in military beneficiaries to gain information to inform the power analysis of a larger, more definitive trial. Researchers do not seek to definitively answer the question of whether this acupuncture protocol is effective; rather, we seek to estimate the proportion of migraine episodes that result in headache-free status 20-30 minutes, 2 hours, 4 hours, and 24 hours after an acupuncture treatment. Acupuncture treatments will be subject dependent, and points could include the N point (on scalp); various auricular points to include Shen Men, Point Zero, thalamus and Omega-2; body points to include Liver 2, Liver 3, Gall Bladder 20, bladder 10; and surface release over tense areas in the neck or shoulders. Researchers will document the points used, and data will be aggregated to determine overall effectiveness. Sub-group analysis by points will be performed to determine if there is more usefulness in 1 point or combination of points. These estimates will inform statistical power calculations for a future randomized controlled trial (RCT) that directly compares the effectiveness of Rescue Acupuncture with medical management of acute migraine with rescue medication. Researchers will also assess the feasibility of this study protocol as well as patient receptivity and satisfaction.
Eligibility Criteria
Inclusion:
- Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study.
- Male and female DoD beneficiaries, age 18 years or older, who have been previously prescribed rescue medication to treat their acute migraine episodes.
Exclusion:
- Pregnant
- Absence of ear
- Active cellulitis of ear
- Ear anatomy precluding identification of acupuncture landmarks
- Use of Hearing Aids that preclude the insertion of needles
- Use of anticoagulants
- Unable to drive during rapid onset of migraine or inability to find someone to drive you
Data sourced from ClinicalTrials.gov (NCT02764996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.