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OpenTrials
Completed

NCT Number: NCT00714727

Set Point Acupuncture for Migraines Using a Digital Assistant

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

John P Murtha Neuroscience and Pain Institute

Johnstown, Pennsylvania, 15904, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Migraines

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.

    Time frame: 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

    Time frame: 32 weeks

Sponsors and collaborators

Lead sponsor

Memorial Medical Center

Other

Collaborators

  • United States Department of Defense

Registry information

Acronym: SPAMDA

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 14, 2008
Registry last updated
Jul 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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