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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.
Male and female (DoD beneficiaries). Age 18 years or older, who meet eligibility criteria will be offered an opportunity to participate via Primary Care Manager (PCM) referrals and posted advertisements will be utilized for recruiting subjects to the study. Some patients may be patients of the Principal Investigator or Associate Investigator, however, they will have the study staff recruit their patients to prevent any misconception of coercion or undue influence. When a potential subject is identified by the treating PCM, the patient will either be provide a contact number to the Research Staff, the Research Staff will be given the potential subjects contact information by the PCM, or the PCM will come and get the Research Staff to speak with the patient directly. Researchers will administer acupuncture treatments for up to 6 different migraine episodes per subject over the course of 3 months. This type of Acupuncture for this indication is routinely done as part of standard-of-care in our Family Medicine and acupuncture clinics both in conjunction with rescue medications and as a stand-alone therapy.
Screening Visit:
Migraine Episode:
Self-reported headache pain severity (0=no headache, 1=mild, 2=moderate, 3=severe) (Standard care)
Record type and amount of rescue medications (over-the-counter and prescription) use in the past 7 days. (research only)
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. (Standard care)
Researchers will document the points used. (Standard care)
*If after 20-30 minutes these patients have not had resolution of their headache, they may take their standard of care rescue medication. (research only)
The subject will sit for 20-30 minutes post-acupuncture(research only), and then the needles will be removed and the subject will be asked:
o Self-reported headache pain severity (0=no headache, 1=mild, 2=moderate, 3=severe) (research only)
Subject is allowed to leave and will be informed of the following telephone follow ups:
2 Hours post acupuncture:
o Self-reported headache pain severity (0=no headache, 1=mild, 2=moderate, 3=severe) (research only)
4 Hours post acupuncture:
o Self-reported headache pain severity (0=no headache, 1=mild, 2=moderate, 3=severe) (research only)
24 Hours post acupuncture:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Migraine Headache Pain | Change of migraine headache pain from mild, moderate or severe to pain free. | 24 hours post treatment. |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Bobnick, DO | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mike O'Callaghan Federal Medical Center | Nellis Air Force Base | Nevada | 89191 | United States |
Researchers are not sharing data
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Acupuncture |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Acupuncture |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of Migraine Headache Pain | Change of migraine headache pain from mild, moderate or severe to pain free. | Posted | Count of Participants | Participants | 24 hours post treatment. |
|
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Acupuncture |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jill Clark, Senior Research Associate/Research Manager | Mike O'Callaghan Miltary Medical Center | (702) 653-3298 | Jill.M.Clark15.ctr@mail.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2016 | May 15, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 29, 2016 | May 15, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
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| D009422 | Nervous System Diseases |