Randomized Controlled Trial of Acupuncture for Dysmenorrhea
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2010
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 3, 2010
CompletedFirst Posted
Study publicly available on registry
May 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedMarch 7, 2013
February 1, 2013
2.3 years
May 3, 2010
March 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
visual analogue scale of pain
every 2 months
Secondary Outcomes (7)
score of questionnaire of quality of life (SF-36)
every 2 months
amount of additional medication
every 2 months
degree of restriction of daily life activities
every 2 months
degree of absence from work or school
every 2 months
overall improvement in dysmenorrhea
end of acupuncture treatment
- +2 more secondary outcomes
Study Arms (2)
Acupuncture
EXPERIMENTALUsual Care
ACTIVE COMPARATORusual care followed by delayed acupuncture
Interventions
acupuncture on the acupoints of ST44 and ST43 of bilateral feet for 2 months, then followed-up for another 2months
usual care with medication and behavior therapy for 2 months, followed by acupuncture for additional 2 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital Yun-Lin Branch
Douliu, 640, Taiwan
Related Publications (1)
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. doi: 10.1016/j.ajog.2007.07.041.
PMID: 18226614BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chien-Hsun Huang, MD, MSc
National Taiwan University Hospital, Yun-Lin Branch
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2010
First Posted
May 5, 2010
Study Start
May 1, 2010
Primary Completion
August 1, 2012
Study Completion
November 1, 2012
Last Updated
March 7, 2013
Record last verified: 2013-02