Acupuncture in Menopause

Not Applicable

Completed

• Conditions: Vasomotor Symptoms
• Interventions: Procedure: Acupuncture

• Registration Number: NCT01276028
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-11
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Study Start: 2011-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 209

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waitlist	Acupuncture	This group of participants will be asked to wait 6 months and will then be allowed to receive acupuncture.
Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
Subjective Hot Flashes	Up to 14 months	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

Name	Time	Method
Objective Hot Flashes	3 days	Objective hot flashes measured by skin conductance
Other Symptoms	Up to 14 months
Quality of Life	Up to 58 weeks	Measures your quality of life over the last week

Trial Locations

Locations (2)

Chapel Hill Doctors; 🇺🇸 Chapel Hill, North Carolina, United States

Wake Forest University Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States