Randomized Controlled Trial of Acupuncture for Dysmenorrhea

Study Overview
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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.

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.

Official Title
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Randomized Controlled Trial of Acupuncture on the Effect of Quality of Life and Clinical Efficacy for Dysmenorrhea Patients.

Conditions
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Dysmenorrhea

Intervention / Treatment
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* Procedure: acupuncture
* Procedure: usual care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br> | Procedure: acupuncture<br>* acupuncture on the acupoints of ST44 and ST43 of bilateral feet for 2 months, then followed-up for another 2months<br>* Other names: body acupuncture;|
| Active Comparator: Usual Care<br>usual care followed by delayed acupuncture | Procedure: usual care<br>* usual care with medication and behavior therapy for 2 months, followed by acupuncture for additional 2 months<br>* Other names: delayed acupuncture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scale of pain |  | every 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dysmenorrhea, acupuncture, randomized controlled trial