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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Huazhong University of Science and Technology.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
The Fifth Hospital of Wuhan
Information provided by:
Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00689897
First received: May 30, 2008
Last updated: June 22, 2011
Last verified: April 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychological Outcomes From a Study of Acupuncture Treatment on Experimentally Primary Dysmenorrhea

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • average duration (hours) of pain [ Time Frame: 90 days after onset ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 30 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Huazhong University of Science and Technology
  More Information

No publications provided

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
Study First Received: May 30, 2008
Last Updated: June 22, 2011
Health Authority: China: Ethics Committee

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
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013