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Completed

NCT Number: NCT01276028

Acupuncture in Menopause

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.

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Key information

Conditions

Vasomotor Symptoms Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chapel Hill Doctors, Chapel Hill, North Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Procedure

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 Traditional Chinese Medicine (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.

Primary outcomes

  1. Subjective Hot Flashes

    Time frame: 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 outcomes

  1. Objective Hot Flashes

    Time frame: 3 days

    Objective hot flashes measured by skin conductance

  2. Other Symptoms

    Time frame: Up to 14 months

  3. Quality of Life

    Time frame: Up to 58 weeks

    Measures your quality of life over the last week

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Acupuncture for Vasomotor Symptoms

Acronym: AIM

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 13, 2011
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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