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Psychological Outcomes From a Study of Acupuncture Treatment on Experimentally Primary Dysmenorrhea

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Huazhong University of Science and Technology.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00689897
First Posted: June 4, 2008
Last Update Posted: June 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Fifth Hospital of Wuhan
Information provided by:
Huazhong University of Science and Technology
  Purpose
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.

Condition Intervention Phase
Primary Dysmenorrhea Procedure: acupuncture, Deqi Procedure: acupuncture, Non-Deqi Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychological Outcomes From a Study of Acupuncture Treatment on Experimentally Primary Dysmenorrhea

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • Visual Analogue Scale for pain intensity of primary dysmenorrhea [ Time Frame: 90 days after onset ]

Secondary Outcome Measures:
  • average duration (hours) of pain [ Time Frame: 90 days after onset ]

Estimated Enrollment: 60
Study Start Date: June 2008
Estimated Study Completion Date: July 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Procedure: acupuncture, Deqi
Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the DeQi sensation.
Other Name: Deqi
Active Comparator: 2
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.
Procedure: acupuncture, Non-Deqi
After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.
Other Name: Non-Deqi

Detailed Description:
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.
  Eligibility

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689897


Contacts
Contact: Guangying Huang 86-027-83663266 Gyhuang@tjh.tjmu.edu.cn

Locations
China, Hubei
Institute of Integrated Traditional Chinese and Western Medicine Recruiting
Wuhan, Hubei, China, 430030
Contact: Fu-er Lu, doctor    86-027-8366-3237    felu@tjh.tjmu.edu.cn   
Contact: Jin Xiong, doctor    Sub-Investigator    sunny19821119@163.com   
Sponsors and Collaborators
Huazhong University of Science and Technology
The Fifth Hospital of Wuhan
Investigators
Principal Investigator: Wei Wang Tongji Hospital
  More Information

Responsible Party: 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
ClinicalTrials.gov Identifier: NCT00689897     History of Changes
Other Study ID Numbers: 2006CB504502-2
First Submitted: May 30, 2008
First Posted: June 4, 2008
Last Update Posted: June 23, 2011
Last Verified: April 2009

Keywords provided by Huazhong University of Science and Technology:
Primary Dysmenorrhea
Deqi
acupuncture
psychology

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms