DysmenorrheaNCT01455285
Effectiveness of the Transcutaneous Electrical Nerve Stimulation in Dysmenorrhea
A study testing transcutaneous electrical nerve stimulation in people with Dysmenorrhea, run by Universidade Federal do Piauí at 1 site in Brazil.
Trial summary
Hypothesis: What is the best modulation of pulse frequency in transcutaneous electrical nerve stimulation in dysmenorrhea? Purpose: To determine the effect of hypoalgesia frequency modulation pulse by transcutaneous electrical nerve (TENS) in dysmenorrhea. Read more about this study
- Who is it for?
- Ages 16 to 33 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- transcutaneous electrical nerve stimulation
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 16 to 33 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- be the first or second day of menstruation
- dysmenorrhea present at the time of application of TENS
- not having undergone any procedure analgesic six hours before the application of TENS
Who cannot join
- not to mention dysmenorrhea at the time of evaluation
- pregnant women
- were using some method of hormonal contraception on an ongoing basis
- had sensory deficits or cognitive and cases of contraindication to TENS application.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Physiotherapy Clinic UFPI / Campus Minister Reis Velloso
Parnaíba, Piauí, 64202-020
About this study
Official title: Investigation of the Effectiveness of Different Modulations of Pulse Frequency Transcutaneous Electrical Nerve Stimulation in Dysmenorrhea
Hypothesis: What is the best modulation of pulse frequency in transcutaneous electrical nerve stimulation in dysmenorrhea? Purpose: To determine the effect of hypoalgesia frequency modulation pulse by transcutaneous electrical nerve (TENS) in dysmenorrhea. Methods: A controlled clinical study and prospective developed at the School of Physiotherapy Clinic / UFPI. Forty students were randomized into four distinct groups of the modulation frequency TENS: group 1 - 100 Hz, 100μs, group 2 - 4 Hz, 100μs, group 3 - placebo (apparatus off), group 4 - placebo induced (2 Hz, 40μs). All were initially evaluated by a questionnaire developed for the study, the visual analogue scale (VAS) (before, after 20, 30, 40, 50, 60 minutes) and the McGill Pain Questionnaire (before and after 20 minutes). The total duration of TENS application was 20 minutes and all protocols were performed in a single session. The analysis of variance (One-way ANOVA) followed by the Tukey procedure was applied to identify differences between experimental groups for each variable analyzed. The level of significance was p< 0,05.
- Conditions
- Dysmenorrhea
- Being tested
- transcutaneous electrical nerve stimulation
- Keywords
- dysmenorrhea, transcutaneous electrical nerve stimulation (TENS, analgesia, pain visual analog scale, McGill pain questionnaire
- Medical subject headings
- Dysmenorrhea, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical nerve stimulationDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Piauí
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455285
- Sponsor's protocol ID
- 0377.0.045.000-10
- Status last verified
- May 2011
- First submitted
- 11 Oct 2011
- Last updated
- 19 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Proctor ML, Smith CA, Farquhar CM, Stones RW. Transcutaneous electrical nerve stimulation and acupuncture for primary dysmenorrhoea. Cochrane Database Syst Rev. 2002;2002(1):CD002123. doi: 10.1002/14651858.CD002123.
PubMed 11869624
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Different Modulations of Pulse Frequency Transcutaneous Electrical Nerve Stimulation in Dysmenorrhea
- ClinicalTrials.gov ID
- NCT01455285
- Acronym / sponsor ID
- 0377.0.045.000-10
- Conditions
- Dysmenorrhea
- Keywords
- dysmenorrhea, transcutaneous electrical nerve stimulation (TENS, analgesia, pain visual analog scale, McGill pain questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Universidade Federal do PiauíUniversity, hospital or other
- First posted
- 19 Oct 2011 (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.
Hypothesis: What is the best modulation of pulse frequency in transcutaneous electrical nerve stimulation in dysmenorrhea? Purpose: To determine the effect of hypoalgesia frequency modulation pulse by transcutaneous electrical nerve (TENS) in dysmenorrhea. Methods: A controlled clinical study and prospective developed at the School of Physiotherapy Clinic / UFPI. Forty students were randomized into four distinct groups of the modulation frequency TENS: group 1 - 100 Hz, 100μs, group 2 - 4 Hz, 100μs, group 3 - placebo (apparatus off), group 4 - placebo induced (2 Hz, 40μs). All were initially evaluated by a questionnaire developed for the study, the visual analogue scale (VAS) (before, after 20, 30, 40, 50, 60 minutes) and the McGill Pain Questionnaire (before and after 20 minutes). The total duration of TENS application was 20 minutes and all protocols were performed in a single session. The analysis of variance (One-way ANOVA) followed by the Tukey procedure was applied to identify differences between experimental groups for each variable analyzed. The level of significance was p< 0,05.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 to 33 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- be the first or second day of menstruation
- dysmenorrhea present at the time of application of TENS
- not having undergone any procedure analgesic six hours before the application of TENS
Key exclusion criteria (4 listed)
- not to mention dysmenorrhea at the time of evaluation
- pregnant women
- were using some method of hormonal contraception on an ongoing basis
- had sensory deficits or cognitive and cases of contraindication to TENS application.
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 electrical nerve stimulation | Device | – |
Primary outcome
Not reported in the source record.
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 19 Oct 2011.
- Results publication: PubMed 11869624Proctor ML, Smith CA, Farquhar CM, Stones RW. Transcutaneous electrical nerve stimulation and acupuncture for primary dysmenorrhoea. Cochrane Database Syst Rev. 2002;2002(1):CD002123. doi: 10.1002/14651858.CD002123.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical nerve stimulation in people with Dysmenorrhea, run by Universidade Federal do Piauí at 1 site in Brazil.
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 3 inclusion and 4 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 19 Oct 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 Brazil. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01455285, which also lists 1 linked publication.
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 19 Oct 2011.