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:
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 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 |
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 |
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 |
|
||||
Original Secondary Outcome Measures ICMJE |
|
||||
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 |
|
||||
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 |
209 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
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 |
|
||||
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 |
|
||||
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 |