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Trial record 16 of 264 for:    Migraine AND Acute Migraine

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

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ClinicalTrials.gov Identifier: NCT02764996
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Military Hospital

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.

Condition or disease Intervention/treatment Phase
Migraine Device: Acupuncture Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Exploratory Prospective Trial of Rescue Acupuncture for the Treatment of Acute Migraine
Actual Study Start Date : December 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Migraine

Arm Intervention/treatment
Experimental: Acupuncture for Migraine
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



Primary Outcome Measures :
  1. Reduction of migraine headache pain [ Time Frame: 24 hours post treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764996


Locations
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United States, Nevada
Mike O'Callaghan Federal Medical Center
Nellis Air Force Base, Nevada, United States, 89191
Sponsors and Collaborators
Mike O'Callaghan Military Hospital
Investigators
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Principal Investigator: Sarah Bobnick, DO Principal Investigator

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Responsible Party: Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT02764996     History of Changes
Other Study ID Numbers: FWH20150084H
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Researchers are not sharing data

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases