Randomized Controlled Trial of Acupuncture for Dysmenorrhea

Phase 3

Completed

• Conditions: Dysmenorrhea
• Interventions: Procedure: acupuncture; Procedure: usual care

• Registration Number: NCT01116453
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Since there is unsatisfactory effect by currently pharmacologic therapies and preventive strategies for dysmenorrhea, this study is designed to evaluate the efficacy and quality of life of acupuncture for patients with dysmenorrhea based on the theory of traditional Chinese Medicine.

Detailed Description

There were abundant clinical experiences and medical records for dysmenorrhea in traditional Chinese medicine. So we follow the worldly trend to do the research of integrative Chinese medicine and western medicine since WHO launched the first global strategy on traditional and complementary/alternative medicine (TM/CAM) to assist countries to create a stronger evidence base on the safety, efficacy and quality of the TM/CAM products and practices.

The purpose of our study is to create the evidence of effect on dysmenorrhea by acupuncture. The study will be performed under randomized, open, controlled design. The effect of acupuncture and control group will be compared including the following outcomes: pain score (Visual Analogue Scale), quality of life (SF-36, Taiwan version), overall improvement in dysmenorrhea, adverse effects from treatment, requirements for additional medication, restriction of daily life activities, absence from work or school.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-05
• Primary Completion: 2012-08
• Study Completion: 2012-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-03-05
• Last Update Posted: 2013-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

• non-pregnant women who are at least 13 years old
• the one who meet any one of the following two criteria: 1.suffering from dysmenorrhea in recent 3 menstrual periods; 2.dysmenorrhea with poor response to non-steroid anti-inflammation drugs

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Exclusion Criteria

• intrauterine device-related dysmenorrhea
• history of alcohol or drug abuser
• women who are pregnant, as determined by a urine pregnancy test
• history of adverse reaction to acupuncture
• received herb or acupuncture therapy within one month prior to enrollment
• poor compliance to investigator's advice

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	acupuncture	-
Usual Care	usual care	usual care followed by delayed acupuncture

Primary Outcome Measures

Name	Time	Method
visual analogue scale of pain	every 2 months

Secondary Outcome Measures

Name	Time	Method
score of questionnaire of quality of life (SF-36)	every 2 months
amount of additional medication	every 2 months
degree of restriction of daily life activities	every 2 months
degree of absence from work or school	every 2 months
overall improvement in dysmenorrhea	end of acupuncture treatment
safety evaluation (adverse events)	every week
score of questionnaire of dysmenorrhea-related symptoms	every 2 months

Trial Locations

Locations (1)

National Taiwan University Hospital Yun-Lin Branch; 🇨🇳 Yun-Lin, Taiwan