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

Phase 3

• Conditions: Primary Dysmenorrhea
• Interventions: Procedure: acupuncture, Deqi; Procedure: acupuncture, Non-Deqi

• Registration Number: NCT00689897
• Lead Sponsor: Huazhong University of Science and Technology

Brief 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.

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.

Study Timeline

• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-05-30
• Study Start: 2008-06
• Study First Posted: 2008-06-04
• Status Verified: 2009-04
• Primary Completion: 2010-09
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	acupuncture, Deqi	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.
2	acupuncture, Non-Deqi	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.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale for pain intensity of primary dysmenorrhea	90 days after onset

Secondary Outcome Measures

Name	Time	Method
average duration (hours) of pain	90 days after onset

Trial Locations

Locations (1)

Institute of Integrated Traditional Chinese and Western Medicine; 🇨🇳 Wuhan, Hubei, China