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

NCT00689897 | Unknown Phase 3 DMC

• 1 other identifier: 2006CB504502-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Keywords

Primary Dysmenorrhea; Deqi; acupuncture; psychology

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale for pain intensity of primary dysmenorrhea

  90 days after onset

Secondary Outcomes (1)

• average duration (hours) of pain

  90 days after onset

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

Interventions

acupuncture, Deqi PROCEDURE

Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the DeQi sensation.

Also known as: Deqi

1

acupuncture, Non-Deqi PROCEDURE

After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.

Also known as: Non-Deqi

2

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female, age between 18 and 30 years old, who had regular menstrual cycles (28-33 days);
• Meeting diagnostic criteria for primary dysmenorrhea, having moderate to severe symptoms when unmedicated, and eligible for care through the military health system.

You may not qualify if:

• Secondary dysmenorrhea;
• Women with systemic disease, or hormonal, psychiatric or gynecologic disorders, or substance abuse;
• Pregnant or trying to conceive, using oral contraceptives, smoker, breast-feeding.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• The Fifth Hospital of Wuhan: collaborator

Study Sites (1)

Institute of Integrated Traditional Chinese and Western Medicine

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Wei Wang

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangying Huang

CONTACT

86-027-83663266; Gyhuang@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 4, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: July 1, 2011
• Last Updated: June 23, 2011

Record last verified: 2009-04

Locations

CN (1)