Set Point Acupuncture for Migraines Using a Digital Assis... | NCT00714727

Studies
Set Point Acupuncture for Migraines Using a Digital Assistant

NCT00714727

Sponsor

Memorial Medical Center

Status

Completed

Last Update Posted

Jul 12, 2013Estimated

Enrollment

50Actual

Phase

Phase 1

Conditions

Migraine Headaches

Interventions

acupuncture

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Jul 10, 2008

First Submission Date that Met QC Criteria

Jul 11, 2008

First Posted Date

Jul 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2013

Last Update Posted Date

Jul 12, 2013Estimated

Name	Class
United States Department of Defense	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other		Procedure: acupuncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		32 weeks

Secondary Outcomes

Measure	Description	Time Frame
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		32 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sharon Plank, MD, LAc	John P. Murtha Neuroscience and Pain Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
John P Murtha Neuroscience and Pain Institute		Johnstown	Pennsylvania	15904	United States

Condition Browse Module

MeSH Terms

ID	Term
D008881	Migraine Disorders
D006261	Headache

Ancestor Terms

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics