search
Back to results

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

Primary Purpose

Migraine Headaches

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Memorial Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Headaches focused on measuring migraine, headache, acupuncture

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • John P Murtha Neuroscience and Pain Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Outcomes

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.

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

Full Information

First Posted
July 10, 2008
Last Updated
July 11, 2013
Sponsor
Memorial Medical Center
Collaborators
United States Department of Defense
search

1. Study Identification

Unique Protocol Identification Number
NCT00714727
Brief Title
Set Point Acupuncture for Migraines Using a Digital Assistant
Acronym
SPAMDA
Official Title
Set Point Acupuncture for Migraines Using a Digital Assistant
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Medical Center
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headaches
Keywords
migraine, headache, acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Other Intervention Name(s)
Migraines
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Plank, MD, LAc
Organizational Affiliation
John P. Murtha Neuroscience and Pain Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
John P Murtha Neuroscience and Pain Institute
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15904
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Set Point Acupuncture for Migraines Using a Digital Assistant

We'll reach out to this number within 24 hrs