The Efficacy of ACupuncture On Menopausal Symptoms (ACOM)
NCT02746497 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2017-11-08
Summary
As a natural part of the menopause the ovaries production of sex hormones declines. This can lead to different menopausal related symptoms. About two-thirds of postmenopausal women experience hot flushes and 10-20% find these hot flushes very stressful.
The aim of this study is to determine and evaluate the efficacy of acupuncture on menopausal symptoms; in particular hot flushes. The study will be a randomized controlled trial. Primary outcome is change in hot flushes. Secondary outcome is change in other menopausal related symptoms.
Conditions
Interventions
- PROCEDURE
-
Acupuncture
Acupuncture style; Western Medical Acupuncture (WMA). In WMA all types of sham (placebo) acupuncture are believed to produce a certain amount of sensory stimulation and thereby a possible therapeutic effect. In addition, other studies have shown that sham acupuncture is associated with a moderately large nonspecific effect and compared to other inert placebo intervention the effect associated with sham acupuncture might be larger. Thus we use a control group instead of a placebo group. Needles; sterile disposable needles (Plandent) size 0.30x30mm. The needles will be inserted perpendicularly and rotated manual between finger and thumb for a few seconds to elicit "de-qi". Needle retention time will be 10 minutes. Afterward the needle will be removed. Acupuncture points; CV-3, CV-4, LR-8, SP-6, SP-9. In total 8 points as LR-8, SP-6, SP-9 are given bilaterally.
Sponsors & Collaborators
-
Section of General Practice, University of Copenhagen
collaborator UNKNOWN -
Research Unit Of General Practice, Copenhagen
collaborator OTHER -
Danish Society for Evidence Based Acupuncture (DSEA)
collaborator UNKNOWN -
Idella Foundation
collaborator UNKNOWN -
University of Southern Denmark
collaborator OTHER -
University of Copenhagen
lead OTHER
Principal Investigators
-
Kamma S Lund, MD · Section of General Practice
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 40 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-10-31
- Primary Completion
- 2017-03-31
- Completion
- 2017-07-31
Countries
- Denmark
Study Locations
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