Clinical Trial: Randomized Controlled Trial of Acupuncture for Dysmenorrhea

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: National Taiwan University Hospital

Current Primary Outcome: visual analogue scale of pain [ Time Frame: every 2 months ]

Original Primary Outcome: visual analogue scale of pain [ Time Frame: every month ]

Current Secondary Outcome:

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


Original Secondary Outcome:

  • score of questionnaire of quality of life (SF-36) [ Time Frame: every month ]
  • amount of additional medication [ Time Frame: every month ]
  • degree of restriction of daily life activities [ Time Frame: every month ]
  • degree of absence from work or school [ Time Frame: every month ]
  • overall improvement in dysmenorrhea [ Time Frame: every month ]
  • safety evaluation (adverse events) [ Time Frame: every week ]
  • score of questionnaire of dysmenorrhea-related symptoms [ Time Frame: every month ]


Information By: National Taiwan University Hospital

Dates:
Date Received: May 3, 2010
Date Started: May 2010
Date Completion:
Last Updated: March 5, 2013
Last Verified: February 2013