Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture in Menopause (AIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01276028
Recruitment Status : Completed
First Posted : January 13, 2011
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE January 11, 2011
First Posted Date  ICMJE January 13, 2011
Last Update Posted Date August 9, 2018
Study Start Date  ICMJE April 2011
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2011)
Subjective Hot Flashes [ Time Frame: Weekly ]
Hot Flashes will be monitored via daily diary. This diary will be filled out daily for the first six months of the study and then 1 week per month for the additional 6 months of the study. Participants are followed approximately 1 year from enrollment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2011)
  • Objective Hot Flashes [ Time Frame: 3 days ]
    Objective hot flashes measured by skin conductance
  • Other Symptoms [ Time Frame: Up to 14 months ]
  • Quality of Life [ Time Frame: Up to 58 weeks ]
    Measures your quality of life over the last week
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2011)
  • Objective Hot Flashes [ Time Frame: 3 days ]
    Hot Flashes will be monitored by a Hot Flash Monitor that the participant will wear 3 days a month for the first six months of the study and then 3 days every other month for the remaining 6 months of the study. The participants are followed for approximately 1 year from enrollment.
  • Other Symptoms [ Time Frame: weekly ]
    Participants will fill out a weekly symptom checklist for the entire year of the study.
  • Quality of Life [ Time Frame: Monthly ]
    Particpants will fill out questionnaires regarding their quality of Life every month for the entire 12 months of the study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture in Menopause
Official Title  ICMJE Acupuncture for Vasomotor Symptoms
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vasomotor Symptoms
Intervention  ICMJE 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 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.

Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Acupuncture
  • Waitlist
    This group of participants will be asked to wait 6 months and will then be allowed to receive acupuncture.
    Intervention: Procedure: Acupuncture
Publications * Avis NE, Coeytaux RR, Isom S, Prevette K, Morgan T. Acupuncture in Menopause (AIM) study: a pragmatic, randomized controlled trial. Menopause. 2016 Jun;23(6):626-37. doi: 10.1097/GME.0000000000000597.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2017)
209
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2011)
200
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01276028
Other Study ID Numbers  ICMJE IRB00014892
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Wake Forest University Health Sciences
Original Responsible Party Nancy Avis, PhD, Wake Forest University Health Sciences
Current Study Sponsor  ICMJE Wake Forest University Health Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Nancy Avis, PhD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP