Primary Dysmenorrhea,Phase 1/2NCT00229164
The Effect of Transcutaneous Electric Nerve Stimulation on Primary Dysmenorrhea-a Randomized Control Study
A Phase 1/2 study testing Transcutaneous Electric Nerve Stimulation (TENS) in people with Primary Dysmenorrhea,, run by National Taiwan University Hospital.
Trial summary
The purpose of this study is to investigate the effect of high frequency TENS and compare to the placebo effect by sham TENS in a randomized control study. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Primary Dysmenorrhea,
- What is being tested?
- Transcutaneous Electric Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Jan 2006
- Phase
- Phase 1/2
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- primary Dysmenorrhea
Who cannot join
- subjects with organic disorders
About this study
The purpose of this study is to investigate the effect of high frequency TENS and compare to the placebo effect by sham TENS in a randomized control study.
Read the detailed description
Over 50% of American women suffered from dysmenorrhea and 10% of them will take sick leave for 1-2 days. Previous randomized control studies have demonstrated the pain relief effect of using high frequency TENS in dysmenorrheal pain. However, no investigation has been conducted to investigate the effect of high frequency TENS in female population in our country. The purpose of this study is to investigate the effect of high frequency TENS and compare to the placebo effect by sham TENS in a randomized control study.
- Conditions
- Primary Dysmenorrhea,
- Being tested
- Transcutaneous Electric Nerve Stimulation (TENS)
- Keywords
- Primary Dysmenorrhea,, Transcutaneous Electric Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electric Nerve Stimulation (TENS)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
all measure the pain threshold,
self-rating questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startOct 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Dysmenorrhea,Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shwu-Fen Wang, Ph.D, Study director, School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229164
- Sponsor's protocol ID
- 9361701148
- Status last verified
- Nov 2012
- First submitted
- 27 Sep 2005
- Last updated
- 27 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Electric Nerve Stimulation on Primary Dysmenorrhea-a Randomized Control Study
- ClinicalTrials.gov ID
- NCT00229164
- Acronym / sponsor ID
- 9361701148
- Conditions
- Primary Dysmenorrhea,
- Keywords
- Primary Dysmenorrhea,, Transcutaneous Electric Nerve Stimulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Jan 2006
- First posted
- 29 Sep 2005 (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 purpose of this study is to investigate the effect of high frequency TENS and compare to the placebo effect by sham TENS in a randomized control study.
Detailed description
Over 50% of American women suffered from dysmenorrhea and 10% of them will take sick leave for 1-2 days. Previous randomized control studies have demonstrated the pain relief effect of using high frequency TENS in dysmenorrheal pain. However, no investigation has been conducted to investigate the effect of high frequency TENS in female population in our country. The purpose of this study is to investigate the effect of high frequency TENS and compare to the placebo effect by sham TENS in a randomized control study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- primary Dysmenorrhea
Key exclusion criteria (1 listed)
- subjects with organic disorders
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 |
|---|---|---|
| Transcutaneous Electric Nerve Stimulation (TENS) | Device | – |
Primary outcome
all measure the pain threshold,
self-rating questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2012.
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The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
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The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity
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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.
Shwu-Fen Wang, Ph.D study director
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transcutaneous Electric Nerve Stimulation (TENS) in people with Primary Dysmenorrhea,, run by National Taiwan University Hospital.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all measure the pain threshold,. The study lists 2 primary outcomes in all. 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 27 Dec 2012.