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Status unknownNCT00689897Updated Jun 23, 2011

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

A Phase 3 interventional study of acupuncture, Deqi and acupuncture, Non-Deqi in Primary Dysmenorrhea, sponsored by Huazhong University of Science and Technology. Status unknown at 1 site in China. Open to female participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2011-06-23.

Sponsored by Huazhong University of Science and Technology · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Primary Dysmenorrhea

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Keywords

  • Primary Dysmenorrhea
  • Deqi
  • acupuncture
  • psychology
03

In context

Dysmenorrhea

398 studies on the registry are indexed under Dysmenorrhea; 96 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 333 interventional studies indexed under Dysmenorrhea.

Browse Dysmenorrhea studies →

Lead sponsor

Huazhong University of Science and Technology is the lead sponsor of 241 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    1

    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

  • Active comparator
    2

    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

  • Procedureacupuncture, Deqi

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

    Also known as: Deqi

  • Procedureacupuncture, Non-Deqi

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

    Also known as: Non-Deqi

06

What researchers measure

Primary outcomes

  1. Visual Analogue Scale for pain intensity of primary dysmenorrhea

    Time frame: 90 days after onset

Secondary outcomes

  1. average duration (hours) of pain

    Time frame: 90 days after onset

07

Study locations

1 of 1 sites recruiting
  • Institute of Integrated Traditional Chinese and Western Medicine
    Wuhan, Hubei 430030, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00689897
Lead sponsor
Huazhong University of Science and Technology
Collaborators
The Fifth Hospital of Wuhan
First posted
Jun 4, 2008
Start date
Jun 2008
Primary completion
Sep 2010
Completion
Jul 2011 (estimated)
Last update
Jun 23, 2011

Study contacts

Guangying Huang
Contact
Gyhuang@tjh.tjmu.edu.cn
86-027-83663266
Wei Wang
principal investigator · Tongji Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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