Primary DysmenorrheaNCT02205970
Application of Electrical Neurostimulation Transcutaneous in Patients With Primary Dysmenorrhea.
A study testing TENS in people with Primary Dysmenorrhea, run by Universidade Federal de Sao Carlos.
Trial summary
The present study aims to verify the analgesic potential of a new methodological proposal for application for transcutaneous electrical nerve stimulation (TENS interactive) using patients with primary dysmenorrhoea and compare it with placebo in a randomized double blind study with convenience sample. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Jul 2014
- 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 18 to 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primary dysmenorrhoea
- Moderate to severe pain
Who cannot join
- Secondary dysmenorrhea
- Users of intrauterine device
- Cognitive impairment
- Failure to appear for treatment
- Pacemaker use
- Illicit drug use
Show all 9Show fewer
- Epilepsy
- Skin problems
- Use of pain medication before the application of TENS
About this study
Official title: Methodological Proposal of Application of Electrical Neurostimulation Transcutaneous (Comparative Study Between Proposed Method of Application Versus Traditional Method in Patients With Primary Dysmenorrhea).
The present study aims to verify the analgesic potential of a new methodological proposal for application for transcutaneous electrical nerve stimulation (TENS interactive) using patients with primary dysmenorrhoea and compare it with placebo in a randomized double blind study with convenience sample.
Read the detailed description
The denouement will be the intensity of pain from visual analogue scale.
- Conditions
- Primary Dysmenorrhea
- Being tested
- TENS, TENS (sham)
- Keywords
- TENS, Dysmenorrhea, analgesia, interactive
- Medical subject headings
- Dysmenorrhea, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
Also called TENS - eletric pulse generator
In the active group there was only one application with interactive TENS (n = 42) with the final parameters of frequency between 90 and 150pps and pulse duration between 300 and 400μs and intensity level of tolerance, lasting 35 minutes.
TENS (sham)Device
In the placebo group, there was a simulated single application, following the same procedures as the active TENS group, also for 35 minutes.
| Study group | Role | What they receive |
|---|---|---|
| TENS active | Active comparator | TENS (interactive): frequency (90 and 150 pps) and pulse duration (300 and 400μs) Receives: Device: TENS |
| TENS sham | Sham comparator | Placebo lasting 35 minutes. Receives: Device: TENS (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure the pain threshold, used to Visual Analogue Scale (VAS)before and after application
To assess pain intensity, will be used to Visual Analogue Scale (VAS), Assessments with EVA are performed before and after treatment of interactive TENS (proposed method). All selected volunteers were subjected to an application of TENS (active or sham) in a single menstrual cycle.
Measured: participants will be monitored for 24 hours
Secondary outcomes (1)
duration of analgesia after application
check the duration of analgesia after application of interactive TENS (proposed method)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startAug 2010
- Primary completionJul 2014
- Study completionJul 2014
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.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Mendes Camilo, Universidade Federal de Sao Carlos
- Investigators
- Fábio M. Camilo, teacher, Principal investigator, Fundação de Educação e Cultura de Santa Fé do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205970
- Sponsor's protocol ID
- UFSaoCarlos0001/14
- Other IDs
- 036/2010
- Status last verified
- Oct 2017
- First submitted
- 28 Jul 2014
- Last updated
- 23 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methodological Proposal of Application of Electrical Neurostimulation Transcutaneous (Comparative Study Between Proposed Method of Application Versus Traditional Method in Patients With Primary Dysmenorrhea).
- ClinicalTrials.gov ID
- NCT02205970
- Acronym / sponsor ID
- UFSaoCarlos0001/14
- Conditions
- Primary Dysmenorrhea
- Keywords
- TENS, Dysmenorrhea, analgesia, interactive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 1 Aug 2014 (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 present study aims to verify the analgesic potential of a new methodological proposal for application for transcutaneous electrical nerve stimulation (TENS interactive) using patients with primary dysmenorrhoea and compare it with placebo in a randomized double blind study with convenience sample.
Detailed description
The denouement will be the intensity of pain from visual analogue scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS active | Active comparator | Device: TENSTENS (interactive): frequency (90 and 150 pps) and pulse duration (300 and 400μs) |
| TENS sham | Sham comparator | Device: TENS (sham)Placebo lasting 35 minutes. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Primary dysmenorrhoea
- Moderate to severe pain
Key exclusion criteria (9 listed)
- Secondary dysmenorrhea
- Users of intrauterine device
- Cognitive impairment
- Failure to appear for treatment
- Pacemaker use
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 |
|---|---|---|
| TENSAlso: TENS - eletric pulse generatorIn the active group there was only one application with interactive TENS (n = 42) with the final parameters of frequency between 90 and 150pps and pulse duration between 300 and 400μs and intensity level of tolerance, lasting 35 minutes. | Device | TENS active |
| TENS (sham)In the placebo group, there was a simulated single application, following the same procedures as the active TENS group, also for 35 minutes. | Device | TENS sham |
Primary outcome
measure the pain threshold, used to Visual Analogue Scale (VAS)before and after application
Time frame: participants will be monitored for 24 hours
To assess pain intensity, will be used to Visual Analogue Scale (VAS), Assessments with EVA are performed before and after treatment of interactive TENS (proposed method). All selected volunteers were subjected to an application of TENS (active or sham) in a single menstrual cycle.
1 secondary outcome
duration of analgesia after application
Time frame: 1 week
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 23 Oct 2017.
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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.
Fábio M. Camilo, teacher principal investigator
Fundação de Educação e Cultura de Santa Fé do Sul
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Primary Dysmenorrhea, run by Universidade Federal de Sao Carlos.
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 9 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 23 Oct 2017. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
measure the pain threshold, used to Visual Analogue Scale (VAS)before and after application (time frame: participants will be monitored for 24 hours). 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 Oct 2017.