Acupuncture in Menopause - Full Text View

Sponsor:	Wake Forest University Baptist Medical Center
Collaborator:	National Institutes of Health (NIH)
Information provided by:	Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:	NCT01276028

Purpose

The primary purpose of this study is to determine the effectiveness of acupuncture for treating vasomotor and other symptoms associated with menopause as acupuncture is generally practiced in the "real world" setting and to obtain a comprehensive assessment of use patterns and symptom relief over time. This study will allow us to determine treatment patterns recommended by practicing acupuncturists, adherence to these treatments, and the effectiveness of different treatment patterns for reducing hot flashes. Results of this study will provide meaningful information to women in terms of number and frequency of acupuncture treatments likely to be needed to reduce hot flashes.

Condition	Intervention	Phase
Vasomotor Symptoms	Procedure: Acupuncture	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Acupuncture for Vasomotor Symptoms

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Acute Bronchitis Menopause

U.S. FDA Resources

Further study details as provided by Wake Forest University Baptist Medical Center:

Primary Outcome Measures:

Subjective Hot Flashes [ Time Frame: Up to 14 months ] [ Designated as safety issue: No ]
Hot Flashes will be monitored via daily diary. This diary will be filled out daily for the first six months (post randomization) of the study and then 1 week per month for the remaining 6 months of the study.

Secondary Outcome Measures:

Objective Hot Flashes [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Objective hot flashes measured by skin conductance
Other Symptoms [ Time Frame: Up to 14 months ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: Up to 58 weeks ] [ Designated as safety issue: No ]
Measures your quality of life over the last week

Estimated Enrollment:	200
Study Start Date:	April 2011

Arms	Assigned Interventions
Experimental: Acupuncture This group will start acupuncture treatments within 3 weeks of consent and continue to receive up to 20 treatments over a six month period. The number of treatments will be jointly determined by the participant and the acupuncturist.	Procedure: Acupuncture For the Acupuncture group: Women will be eligible to receive from 1 to 20 treatments over a six month period. These women will receive an initial evaluation by a acupuncturist and will be given a TCM diagnosis as well as a recommended treatment schedule which they can then negotiate. Women in the waitlist group will not receive any acupuncture for 6 months. At the end of the 6 month period the participants will be allowed to begin the acupuncture treatments.
No Intervention: Waitlist This group of participants will be asked to wait 6 months and will then be allowed to receive acupuncture.	Procedure: Acupuncture For the Acupuncture group: Women will be eligible to receive from 1 to 20 treatments over a six month period. These women will receive an initial evaluation by a acupuncturist and will be given a TCM diagnosis as well as a recommended treatment schedule which they can then negotiate. Women in the waitlist group will not receive any acupuncture for 6 months. At the end of the 6 month period the participants will be allowed to begin the acupuncture treatments.

Arms

Assigned Interventions

Experimental: Acupuncture

This group will start acupuncture treatments within 3 weeks of consent and continue to receive up to 20 treatments over a six month period. The number of treatments will be jointly determined by the participant and the acupuncturist.

Procedure: Acupuncture

For the Acupuncture group: Women will be eligible to receive from 1 to 20 treatments over a six month period. These women will receive an initial evaluation by a acupuncturist and will be given a TCM diagnosis as well as a recommended treatment schedule which they can then negotiate.

Women in the waitlist group will not receive any acupuncture for 6 months. At the end of the 6 month period the participants will be allowed to begin the acupuncture treatments.

No Intervention: Waitlist

This group of participants will be asked to wait 6 months and will then be allowed to receive acupuncture.

Procedure: Acupuncture

For the Acupuncture group: Women will be eligible to receive from 1 to 20 treatments over a six month period. These women will receive an initial evaluation by a acupuncturist and will be given a TCM diagnosis as well as a recommended treatment schedule which they can then negotiate.

Women in the waitlist group will not receive any acupuncture for 6 months. At the end of the 6 month period the participants will be allowed to begin the acupuncture treatments.

Eligibility

Ages Eligible for Study:	45 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women experiencing on average 4 Hot Flashes a day
Women aged 45-60
Peri or Post menopausal Women (No periods for at least 3 months)

Exclusion Criteria:

Women who have initiated CAM or non-CAM treatments for hot flashes in the last 4 weeks
Women who have changed their dose of a CAM or non-CAM treatments for hot flashes in the last 4 weeks
Women who have initiated antidepressants in the last 3 months
Women who have changed their dose of an antidepressant in the last 3 months
Women who have had acupuncture in the last 4 weeks
Women who have received acupuncture from one of the study acupuncturists in the last 6 months will be excluded from the study
Women who describe their health as fair or poor are excluded from the study
Women who have a diagnosis of Hemophilia
Relatives and Co-Workers of the treating acupuncturists

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01276028

Contacts

Contact: Kristen N Prevette, BA

336-713-0246

krprevet@wfubmc.edu

Locations

United States, North Carolina
Chapel Hill Doctors	Recruiting
Chapel Hill, North Carolina, United States
Principal Investigator: Kris Coeytaux, M.Ed
Wake Forest University Baptist Medical Center	Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Kristen Prevette 336-713-0246
Principal Investigator: Nancy Avis, PhD

Sponsors and Collaborators

Wake Forest University Baptist Medical Center

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Nancy Avis, PhD

Wake Forest University

More Information

No publications provided

Responsible Party:	Nancy Avis, PhD, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:	NCT01276028 History of Changes
Other Study ID Numbers:	IRB00014892
Study First Received:	January 11, 2011
Last Updated:	February 15, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Wake Forest University Baptist Medical Center:

Acupuncture
Hot Flashes
Menopause
Vasomotor Symptoms

ClinicalTrials.gov processed this record on May 23, 2012