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

May 3, 2010
March 5, 2013
May 2010
August 2012   (final data collection date for primary outcome measure)
visual analogue scale of pain [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
visual analogue scale of pain [ Time Frame: every month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01116453 on ClinicalTrials.gov Archive Site
  • 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 ]
  • score of questionnaire of quality of life (SF-36) [ Time Frame: every month ] [ Designated as safety issue: No ]
  • amount of additional medication [ Time Frame: every month ] [ Designated as safety issue: No ]
  • degree of restriction of daily life activities [ Time Frame: every month ] [ Designated as safety issue: No ]
  • degree of absence from work or school [ Time Frame: every month ] [ Designated as safety issue: No ]
  • overall improvement in dysmenorrhea [ Time Frame: every month ] [ 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 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Dysmenorrhea
  • 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
  • Procedure: usual care
    usual care with medication and behavior therapy for 2 months, followed by acupuncture for additional 2 months
    Other Name: delayed acupuncture
  • Experimental: Acupuncture
    Intervention: Procedure: acupuncture
  • Active Comparator: Usual Care
    usual care followed by delayed acupuncture
    Intervention: Procedure: usual care
Witt CM, Reinhold T, Brinkhaus B, Roll S, Jena S, Willich SN. Acupuncture in patients with dysmenorrhea: a randomized study on clinical effectiveness and cost-effectiveness in usual care. Am J Obstet Gynecol. 2008 Feb;198(2):166.e1-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
November 2012
August 2012   (final data collection date for primary outcome measure)

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
Female
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01116453
201002022R
Yes
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Chien-Hsun Huang, MD, MSc National Taiwan University Hospital, Yun-Lin Branch
National Taiwan University Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP