Set Point Acupuncture for Migraines Using a Digital Assistant (SPAMDA)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Medical Center
ClinicalTrials.gov Identifier:
NCT00714727
First received: July 10, 2008
Last updated: July 11, 2013
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Migraine Headaches
Procedure: acupuncture
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Set Point Acupuncture for Migraines Using a Digital Assistant

Resource links provided by NLM:


Further study details as provided by Memorial Medical Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Procedure: acupuncture
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.
Other Names:
  • Acupuncture
  • Migraines

Detailed Description:

Subjects will be recording daily headache activity on personal digital assistants (PDA's) for 12 weeks before and 12 weeks after 8 weeks of acupuncture intervention. MIDAS, HIT-6 and BDI-II measurements will be done at the beginning of the study (12 weeks pre-intervention), directly before the intervention, directly after, and 12 weeks post-intervention. Measurements will be compared before and after intervention. This is a follow-up to a successful earlier study when these same acupuncture points were used on subjects with chronic daily headache, the majority being migraine.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00714727

Locations
United States, Pennsylvania
John P Murtha Neuroscience and Pain Institute
Johnstown, Pennsylvania, United States, 15904
Sponsors and Collaborators
Memorial Medical Center
Investigators
Principal Investigator: Sharon Plank, MD, LAc John P. Murtha Neuroscience and Pain Institute
  More Information

No publications provided

Responsible Party: Memorial Medical Center
ClinicalTrials.gov Identifier: NCT00714727     History of Changes
Other Study ID Numbers: MMC 07-12
Study First Received: July 10, 2008
Last Updated: July 11, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Medical Center:
migraine
headache
acupuncture

Additional relevant MeSH terms:
Headache
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014