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

Primary Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00689897
• Other study ID #: 2006CB504502-2
• Status: Recruiting
• Phase: Phase 3
• First received: May 30, 2008
• Last updated: June 22, 2011
• Start date: June 2008
• Est. completion date: July 2011

Study information

• Verified date: April 2009
• Source: Huazhong University of Science and Technology
• Contact: Guangying Huang
• Phone: 86-027-83663266
• Email: Gyhuang[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Procedure:
• acupuncture, Deqi
Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the DeQi sensation.
• acupuncture, Non-Deqi
After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.

Locations

Country	Name	City	State
China	Institute of Integrated Traditional Chinese and Western Medicine	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	The Fifth Hospital of Wuhan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale for pain intensity of primary dysmenorrhea		90 days after onset	No
Secondary	average duration (hours) of pain		90 days after onset	No