Clinical trial NCT00714727: Set Point Acupuncture for Migraines Using a Digital Assistant
Official title: Set Point Acupuncture for Migraines Using a Digital Assistant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine Headaches
Keywords: migraine
headache
acupuncture
Lead sponsor: Memorial Medical Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2008-07-14
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: 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.
timeFrame: 32 weeks
Secondary outcomes:
measure: 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
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Johnstown
country: United States
facility: John P Murtha Neuroscience and Pain Institute
state: Pennsylvania
Study officials:
affiliation: John P. Murtha Neuroscience and Pain Institute
name: Sharon Plank, MD, LAc
role: PRINCIPAL_INVESTIGATOR
References: