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

Huazhong University of Science and Technology

Status and phase: Unknown; Phase 3

Conditions: Primary Dysmenorrhea

Treatments: Procedure: acupuncture, Deqi; Procedure: acupuncture, Non-Deqi

Study type: Interventional

Funder types: Other

Identifiers

NCT00689897

2006CB504502-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Procedure: acupuncture, Deqi

2

Active Comparator group

Description:

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.

Treatment:

Procedure: acupuncture, Non-Deqi