Randomized Controlled Trial of Acupuncture for Dysmenorrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01116453
Recruitment Status : Completed
First Posted : May 5, 2010
Last Update Posted : March 7, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dysmenorrhea Procedure: acupuncture Procedure: usual care Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Acupuncture on the Effect of Quality of Life and Clinical Efficacy for Dysmenorrhea Patients.
Study Start Date : May 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Acupuncture Procedure: acupuncture
acupuncture on the acupoints of ST44 and ST43 of bilateral feet for 2 months, then followed-up for another 2months
Other Name: body acupuncture

Active Comparator: Usual Care
usual care followed by delayed acupuncture
Procedure: usual care
usual care with medication and behavior therapy for 2 months, followed by acupuncture for additional 2 months
Other Name: delayed acupuncture

Primary Outcome Measures :
  1. visual analogue scale of pain [ Time Frame: every 2 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01116453

National Taiwan University Hospital Yun-Lin Branch
Yun-Lin, Taiwan, 640
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Chien-Hsun Huang, MD, MSc National Taiwan University Hospital, Yun-Lin Branch

Responsible Party: National Taiwan University Hospital Identifier: NCT01116453     History of Changes
Other Study ID Numbers: 201002022R
First Posted: May 5, 2010    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: February 2013

Keywords provided by National Taiwan University Hospital:
randomized controlled trial

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Neurologic Manifestations
Signs and Symptoms