NCT01116453

Randomized Controlled Trial of Acupuncture for Dysmenorrhea

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: Female
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
PROCEDURE	acupuncture	acupuncture on the acupoints of ST44 and ST43 of bilateral feet for 2 months, then followed-up for another 2months
PROCEDURE	usual care	usual care with medication and behavior therapy for 2 months, followed by acupuncture for additional 2 months

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-08-01
• Completion: 2012-11-01
• First posted: 2010-05-05
• Last updated: 2013-03-07

Locations

1 site across 1 country: Taiwan