An Exploratory Prospective Trial of Rescue Acupuncture for the Treatment of Acute Migraine

NCT02764996 | Completed Results

• 1 other identifier: FWH20150084H
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Migraine

Outcome Measures

Primary Outcomes (1)

• Change of Migraine Headache Pain

  Change of migraine headache pain from mild, moderate or severe to pain free.

  24 hours post treatment.

Study Arms (1)

Acupuncture for Migraine

EXPERIMENTAL

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

Device: Acupuncture

Interventions

Acupuncture DEVICE

Acupuncture for Migraine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

Study Sites (1)

Mike O'Callaghan Federal Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Jill Clark, Senior Research Associate/Research Manager
• Organization: Mike O'Callaghan Miltary Medical Center

Jill.M.Clark15.ctr@mail.mil

(702) 653-3298

Study Officials

• Sarah Bobnick, DO

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 6, 2016
• Study Start: December 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 5, 2024
• Results First Posted: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)