The Efficacy of ACupuncture On Menopausal Symptoms (ACOM)

NCT02746497 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-11-08

No results posted yet for this study

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02746497 on ClinicalTrials.gov