Randomized Controlled Trial of Acupuncture for Dysmenorrhea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01116453
First received: May 3, 2010
Last updated: March 5, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Dysmenorrhea
Procedure: acupuncture
Procedure: usual care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • visual analogue scale of pain [ Time Frame: every 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • score of questionnaire of quality of life (SF-36) [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
  • amount of additional medication [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
  • degree of restriction of daily life activities [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
  • degree of absence from work or school [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
  • overall improvement in dysmenorrhea [ Time Frame: end of acupuncture treatment ] [ Designated as safety issue: No ]
  • safety evaluation (adverse events) [ Time Frame: every week ] [ Designated as safety issue: Yes ]
  • score of questionnaire of dysmenorrhea-related symptoms [ Time Frame: every 2 months ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: May 2010
Study Completion Date: November 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116453

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

Publications:
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01116453     History of Changes
Other Study ID Numbers: 201002022R
Study First Received: May 3, 2010
Last Updated: March 5, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
dysmenorrhea
acupuncture
randomized controlled trial

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

ClinicalTrials.gov processed this record on July 24, 2014