| 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
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- 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.
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| |
| |
| Recruiting |
| 60 |
| September 2009 |
| September 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Female, age between 18 and 30 years old, who had regular menstrual cycles (28-33 days);
- Meeting diagnostic criteria for primary dysmenorrhea, having moderate to severe symptoms when unmedicated, and eligible for care through the military health system.
Exclusion Criteria:
- Secondary dysmenorrhea;
- Women with systemic disease, or hormonal, psychiatric or gynecologic disorders, or substance abuse;
- Pregnant or trying to conceive, using oral contraceptives, smoker, breast-feeding.
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| Female |
| 18 Years to 30 Years |
| No |
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| 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 |
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| Huazhong University of Science and Technology |
| April 2009 |