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

Primary Purpose

Primary Dysmenorrhea

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

acupuncture, Deqi

acupuncture, Non-Deqi

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Primary Dysmenorrhea, Deqi, acupuncture, psychology

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Institute of Integrated Traditional Chinese and Western MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 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.

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.

Outcomes

Primary Outcome Measures

Visual Analogue Scale for pain intensity of primary dysmenorrhea

Secondary Outcome Measures

average duration (hours) of pain

Full Information

NCT ID

NCT00689897

First Posted

May 30, 2008

Last Updated

June 22, 2011

Sponsor

Huazhong University of Science and Technology

Collaborators

The Fifth Hospital of Wuhan

1. Study Identification

Unique Protocol Identification Number

NCT00689897

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Unknown status

Study Start Date

June 2008 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Huazhong University of Science and Technology

Collaborators

The Fifth Hospital of Wuhan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Dysmenorrhea

Keywords

Primary Dysmenorrhea, Deqi, acupuncture, psychology

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm 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.

Arm Title

Arm Type

Active Comparator

Arm 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.

Intervention Type

Procedure

Intervention Name(s)

acupuncture, Deqi

Other Intervention Name(s)

Deqi

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

acupuncture, Non-Deqi

Other Intervention Name(s)

Non-Deqi

Intervention Description

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

Primary Outcome Measure Information:

Title

Visual Analogue Scale for pain intensity of primary dysmenorrhea

Time Frame

90 days after onset

Secondary Outcome Measure Information:

Title

average duration (hours) of pain

Time Frame

90 days after onset

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guangying Huang

Phone

86-027-83663266

Gyhuang@tjh.tjmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Wang

Organizational Affiliation

Tongji Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Integrated Traditional Chinese and Western Medicine

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fu-er Lu, doctor

Phone

86-027-8366-3237

felu@tjh.tjmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Jin Xiong, doctor

Phone

Sub-Investigator

sunny19821119@163.com

12. IPD Sharing Statement

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

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