An interventional study of Acupuncture in Vasomotor Symptoms, sponsored by Wake Forest University Health Sciences. Completed at 2 sites in United States. Open to female participants aged 45 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-08-09.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
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Exclusion Criteria:
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.
Procedure: Acupuncture
This group of participants will be asked to wait 6 months and will then be allowed to receive acupuncture.
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.
Subjective Hot Flashes
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.
Time frame: Up to 14 months
Objective Hot Flashes
Objective hot flashes measured by skin conductance
Time frame: 3 days
Other Symptoms
Time frame: Up to 14 months
Quality of Life
Measures your quality of life over the last week
Time frame: Up to 58 weeks
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences