Randomized Controlled Trial of Acupuncture for Dysmenorrhea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acupuncture

Group Type EXPERIMENTAL

acupuncture

Intervention Type PROCEDURE

acupuncture on the acupoints of ST44 and ST43 of bilateral feet for 2 months, then followed-up for another 2months

Usual Care

usual care followed by delayed acupuncture

Group Type ACTIVE_COMPARATOR

usual care

Intervention Type PROCEDURE

usual care with medication and behavior therapy for 2 months, followed by acupuncture for additional 2 months

Interventions

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acupuncture

acupuncture on the acupoints of ST44 and ST43 of bilateral feet for 2 months, then followed-up for another 2months

Intervention Type PROCEDURE

usual care

usual care with medication and behavior therapy for 2 months, followed by acupuncture for additional 2 months

Intervention Type PROCEDURE

Other Intervention Names

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body acupuncture delayed acupuncture

Eligibility Criteria

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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

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

Minimum Eligible Age

13 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No