Set Point Acupuncture for Migraines Using a Digital Assistant

NCT00714727 | Completed Phase 1

• 1 other identifier: MMC 07-12
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The object of this research study is to test a standardized set of acupuncture points on migraine patients to reduce frequency and intensity of headaches. Acupuncture has been studied in prior research but the treatment points have varied between subjects, making it difficult to replicate studies.

Conditions

Migraine Headaches

Keywords

migraine; headache; acupuncture

Outcome Measures

Primary Outcomes (1)

• If a standard set of acupuncture points delivered over a set time frame, reduces the frequency and intensity of headaches in a population of migraine sufferers.

  32 weeks

Secondary Outcomes (1)

• Measurements of the impact of acupuncture intervention will be detected when baseline measurements of frequency and severity of headaches is compared to measurements taken 12 weeks after the last acupuncture session. MIDAS, HIT-6, BDI-II and SF-12 scores

  32 weeks

Study Arms (1)

1

OTHER

Procedure: acupuncture

Interventions

acupuncture PROCEDURE

8 weeks of acupuncture, starting with twice a week for 4 weeks, followed by once a week for 4 weeks, using 8 standardized, bilateral acupuncture points.

Also known as: Migraines

1

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects between the ages of 21 years and 65 years of age
• Subjects with a history of migraine headaches for at least 12 months
• Subjects who have not received acupuncture for any medical condition in the past 6 months.
• A negative pregnancy test for childbearing females since some acupuncture points may be contraindicated in pregnancy. Pregnancy tests will be conducted at MMC.
• Subjects willing and able to use a PDA daily for data collection

You may not qualify if:

• Subjects who plan to receive acupuncture treatment for any other type of medical condition while enrolled in this protocol
• Subjects with the presence of organic pathology (i.e., brain tumor)
• Subjects who have the presence of a systemic disorder or illness, including serious psychiatric illness
• Subjects who began a new headache treatment less than two weeks before proposed enrollment date
• Subjects who are pregnant, lactating, or planning to become pregnant within 6 months
• Subjects that use alcohol on a regular basis
• Subjects that use recreational drugs
• Subjects that have a cardiac pacemaker
• Subjects that use analgesics on more than 10 days per month
• Subjects that exercise prophylactic headache treatment with drugs during the past 4 weeks

Sponsors & Collaborators

• Memorial Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

John P Murtha Neuroscience and Pain Institute

Johnstown, Pennsylvania, 15904, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Sharon Plank, MD, LAc

  John P. Murtha Neuroscience and Pain Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 14, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: July 12, 2013

Record last verified: 2009-09

Locations

US (1)