Primary DysmenorrheaPhase 3NCT00689897
Psychological Outcomes From a Study of Acupuncture Treatment on Experimentally Primary Dysmenorrhea
A Phase 3 study testing acupuncture, Deqi and acupuncture, Non-Deqi in people with Primary Dysmenorrhea, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- acupuncture, Deqi and acupuncture, Non-Deqi
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2008to Jul 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Integrated Traditional Chinese and Western Medicine
Wuhan, Hubei, 430030
Fu-er Lu, doctor, 86-027-8366-3237, felu@tjh.tjmu.edu.cn
Jin Xiong, doctor, Sub-Investigator, sunny19821119@163.com
About this study
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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- acupuncture, Deqi, acupuncture, Non-Deqi
- Keywords
- Primary Dysmenorrhea, Deqi, acupuncture, psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture, DeqiProcedure or surgery
Also called Deqi
Immediately after insertion of a needle, it is manually rotated backwards and forwards to induce the DeQi sensation.
acupuncture, Non-DeqiProcedure or surgery
Also called Non-Deqi
After insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: acupuncture, Non-Deqi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale for pain intensity of primary dysmenorrhea
Measured: 90 days after onset
Secondary outcomes (1)
average duration (hours) of pain
Measured: 90 days after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2010
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The Fifth Hospital of Wuhan
- Investigators
- Wei Wang, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689897
- Sponsor's protocol ID
- 2006CB504502-2
- Status last verified
- Apr 2009
- First submitted
- 30 May 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Outcomes From a Study of Acupuncture Treatment on Experimentally Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT00689897
- Acronym / sponsor ID
- 2006CB504502-2
- Conditions
- Primary Dysmenorrhea
- Keywords
- Primary Dysmenorrhea, Deqi, acupuncture, psychology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- The Fifth Hospital of Wuhan
- Study start
- Jun 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jul 2011 (estimated)
- First posted
- 4 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: acupuncture, DeqiIn 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 | Active comparator | Procedure: acupuncture, Non-DeqiIn 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncture, DeqiAlso: DeqiImmediately after insertion of a needle, it is manually rotated backwards and forwards to induce the DeQi sensation. | Procedure or surgery | 1 |
| acupuncture, Non-DeqiAlso: Non-DeqiAfter insertion of a needle, no manipulation is applied, and the needle is retained for 30 minutes. | Procedure or surgery | 2 |
Primary outcome
Visual Analogue Scale for pain intensity of primary dysmenorrhea
Time frame: 90 days after onset
1 secondary outcome
average duration (hours) of pain
Time frame: 90 days after onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Wang principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing acupuncture, Deqi and acupuncture, Non-Deqi in people with Primary Dysmenorrhea, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guangying Huang (86-027-83663266, Gyhuang@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale for pain intensity of primary dysmenorrhea (time frame: 90 days after onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.