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CompletedNCT00714727SPAMDAUpdated Jul 12, 2013

Set Point Acupuncture for Migraines Using a Digital Assistant

A Phase 1 interventional study of acupuncture in Migraine Headaches, sponsored by Memorial Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-12.

Sponsored by Memorial Medical Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
21 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Migraine Headaches

Keywords

  • migraine
  • headache
  • acupuncture
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 50 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Memorial Medical Center is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Other
    1

    Procedure: acupuncture

Interventions

  • Procedureacupuncture

    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

06

What researchers measure

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

07

Study locations

1 site
  • John P Murtha Neuroscience and Pain Institute
    Johnstown, Pennsylvania 15904, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00714727
Lead sponsor
Memorial Medical Center
Collaborators
United States Department of Defense
Responsible party
Sponsor
First posted
Jul 14, 2008
Start date
Jul 2008
Primary completion
Jan 2011
Completion
Jan 2011
Last update
Jul 12, 2013

Study contacts

Sharon Plank, MD, LAc
principal investigator · John P. Murtha Neuroscience and Pain Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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