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Psychological Outcomes From a Study of Acupuncture Treatment on Experimentally Primary Dysmenorrhea
This study is currently recruiting participants.
Study NCT00689897   Information provided by Huazhong University of Science and Technology
First Received: May 30, 2008   Last Updated: April 13, 2009   History of Changes

May 30, 2008
April 13, 2009
June 2008
September 2009   (final data collection date for primary outcome measure)
Visual Analogue Scale for pain intensity of primary dysmenorrhea [ Time Frame: 90 days after onset ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00689897 on ClinicalTrials.gov Archive Site
average duration (hours) of pain [ Time Frame: 90 days after onset ] [ Designated as safety issue: No ]
average duration(hours) of pain [ Time Frame: 90 days after onset ] [ Designated as safety issue: No ]
 
Psychological Outcomes From a Study of Acupuncture Treatment on Experimentally Primary Dysmenorrhea
Psychological Outcomes From a Study of Acupuncture Treatment on Experimentally Primary Dysmenorrhea

The objective of this study is to evaluate the associations between deqi, the effects of acupuncture and personality in primary dysmenorrhea and to characterize the nature of the deqi phenomenon on terms of the prevalence of sensations as well as the uniqueness of the sensations underlying the deqi experiment.

The mechanism, by which acupuncture works is not yet clear, therefore there is no unequivocal consensus about styles and sensations of acupuncture. whether psychological factor has influences on the effects of acupuncture? This study will adopt international practices such as visual analogue scale (VAS) to objective evaluation. The confident degree, feeling degree for acupuncture and pain intensity were evaluated by the patient with VAS, and the pain VAS scores before and after acupuncture were recorded as the indexes for assessment of the therapeutic effect.

Phase III
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Historical Control, Parallel Assignment, Safety/Efficacy Study
Primary Dysmenorrhea
  • Procedure: acupuncture, Deqi
  • Procedure: acupuncture, Non-Deqi
  • Experimental: In acupuncture treatment, immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the DeQi sensation, the needles are retained for 30 minutes.
  • Active Comparator: In acupuncture treatment, immediately after insertion of a needle, it is NOT manually rotated backwards or forwards to induce the DeQi sensation, and retained for 30 minutes.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
60
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Female, age between 18 and 30 years old, who had regular menstrual cycles (28-33 days);
  2. Meeting diagnostic criteria for primary dysmenorrhea, having moderate to severe symptoms when unmedicated, and eligible for care through the military health system.

Exclusion Criteria:

  1. Secondary dysmenorrhea;
  2. Women with systemic disease, or hormonal, psychiatric or gynecologic disorders, or substance abuse;
  3. Pregnant or trying to conceive, using oral contraceptives, smoker, breast-feeding.
Female
18 Years to 30 Years
No
Contact: Guangying Huang 86-027-83663266 Gyhuang@tjh.tjmu.edu.cn
China
 
NCT00689897
Psychological Outcomes From a Study of Acupuncture Treatment on Experimentally Primary Dysmenorrhea, Institute of Integrated Traditional Chinese and Western Medicine , Department of Neurology of Tongji Hospital,Huazhong University of Science and Technology
2006CB504502-2
Huazhong University of Science and Technology
The Fifth Hospital of Wuhan
Principal Investigator: Wei Wang Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology
Huazhong University of Science and Technology
April 2009

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