Acupuncture in Menopause (AIM)

• ClinicalTrials.gov Identifier: NCT01276028
• Recruitment Status: Completed
• First Posted: January 13, 2011
• Last Update Posted: August 9, 2018
• Sponsor: Wake Forest University Health Sciences
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Tracking Information

• First Submitted Date: January 11, 2011
• First Posted Date: January 13, 2011
• Last Update Posted Date: August 9, 2018
• Study Start Date: April 2011
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Acupuncture in Menopause
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Vasomotor Symptoms

Intervention

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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 8, 2017): 209
• Original Estimated Enrollment (submitted: January 12, 2011): 200
• Actual Study Completion Date: July 2014
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 45 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01276028
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Wake Forest University Health Sciences
• Original Responsible Party: Nancy Avis, PhD, Wake Forest University Health Sciences
• Current Study Sponsor: Wake Forest University Health Sciences
• Original Study Sponsor: Same as current
• Collaborators: National Institutes of Health (NIH)

Investigators

• Principal Investigator: Nancy Avis, PhD; Wake Forest University Health Sciences

• PRS Account: Wake Forest University Health Sciences
• Verification Date: August 2018