Set Point Acupuncture for Migraines Using a Digital Assistant (SPAMDA)
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ClinicalTrials.gov Identifier: NCT00714727 |
Recruitment Status
:
Completed
First Posted
: July 14, 2008
Last Update Posted
: July 12, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine Headaches | Procedure: acupuncture | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Set Point Acupuncture for Migraines Using a Digital Assistant |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | January 2011 |
Arm | Intervention/treatment |
---|---|
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 Name: Migraines
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 21 Years to 65 Years (Adult) |
Sexes Eligible for Study: | 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00714727
United States, Pennsylvania | |
John P Murtha Neuroscience and Pain Institute | |
Johnstown, Pennsylvania, United States, 15904 |
Principal Investigator: | Sharon Plank, MD, LAc | John P. Murtha Neuroscience and Pain Institute |
Responsible Party: | Memorial Medical Center |
ClinicalTrials.gov Identifier: | NCT00714727 History of Changes |
Other Study ID Numbers: |
MMC 07-12 |
First Posted: | July 14, 2008 Key Record Dates |
Last Update Posted: | July 12, 2013 |
Last Verified: | September 2009 |
Keywords provided by Memorial Medical Center:
migraine headache acupuncture |
Additional relevant MeSH terms:
Migraine Disorders Headache Headache Disorders, Primary Headache Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms |