Randomized Controlled Trial of Acupuncture for Dysmenorrhea
Primary Purpose
Dysmenorrhea
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture
usual care
Sponsored by
About this trial
This is an interventional treatment trial for Dysmenorrhea focused on measuring dysmenorrhea, acupuncture, randomized controlled trial
Eligibility 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
Sites / Locations
- National Taiwan University Hospital Yun-Lin Branch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Acupuncture
Usual Care
Arm Description
usual care followed by delayed acupuncture
Outcomes
Primary Outcome Measures
visual analogue scale of pain
Secondary Outcome Measures
score of questionnaire of quality of life (SF-36)
amount of additional medication
degree of restriction of daily life activities
degree of absence from work or school
overall improvement in dysmenorrhea
safety evaluation (adverse events)
score of questionnaire of dysmenorrhea-related symptoms
Full Information
NCT ID
NCT01116453
First Posted
May 3, 2010
Last Updated
March 5, 2013
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01116453
Brief Title
Randomized Controlled Trial of Acupuncture for Dysmenorrhea
Official Title
Randomized Controlled Trial of Acupuncture on the Effect of Quality of Life and Clinical Efficacy for Dysmenorrhea Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
Keywords
dysmenorrhea, acupuncture, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
usual care followed by delayed acupuncture
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Other Intervention Name(s)
body acupuncture
Intervention Description
acupuncture on the acupoints of ST44 and ST43 of bilateral feet for 2 months, then followed-up for another 2months
Intervention Type
Procedure
Intervention Name(s)
usual care
Other Intervention Name(s)
delayed acupuncture
Intervention Description
usual care with medication and behavior therapy for 2 months, followed by acupuncture for additional 2 months
Primary Outcome Measure Information:
Title
visual analogue scale of pain
Time Frame
every 2 months
Secondary Outcome Measure Information:
Title
score of questionnaire of quality of life (SF-36)
Time Frame
every 2 months
Title
amount of additional medication
Time Frame
every 2 months
Title
degree of restriction of daily life activities
Time Frame
every 2 months
Title
degree of absence from work or school
Time Frame
every 2 months
Title
overall improvement in dysmenorrhea
Time Frame
end of acupuncture treatment
Title
safety evaluation (adverse events)
Time Frame
every week
Title
score of questionnaire of dysmenorrhea-related symptoms
Time Frame
every 2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chien-Hsun Huang, MD, MSc
Organizational Affiliation
National Taiwan University Hospital, Yun-Lin Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital Yun-Lin Branch
City
Yun-Lin
ZIP/Postal Code
640
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
18226614
Citation
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.
Results Reference
background
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Randomized Controlled Trial of Acupuncture for Dysmenorrhea
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