An Exploratory Prospective Trial of Rescue Acupuncture for the Treatment of Acute Migraine
NCT02764996 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2024-04-05
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.
Conditions
Interventions
- DEVICE
-
Acupuncture
Sponsors & Collaborators
-
Mike O'Callaghan Military Hospital
lead FED
Principal Investigators
-
Sarah Bobnick, DO · Principal Investigator
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-31
- Primary Completion
- 2017-06-30
- Completion
- 2017-06-30
Countries
- United States
Study Locations
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