Application of Electrical Neurostimulation Transcutaneous in Patients With Primary Dysmenorrhea.

NCT ID: NCT02205970

Last Updated: 2017-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The denouement will be the intensity of pain from visual analogue scale.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Dysmenorrhea

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

TENS Dysmenorrhea analgesia interactive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
one arm study

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TENS active

TENS (interactive): frequency (90 and 150 pps) and pulse duration (300 and 400μs)

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type DEVICE

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

Placebo lasting 35 minutes.

Group Type SHAM_COMPARATOR

TENS (sham)

Intervention Type DEVICE

In the placebo group, there was a simulated single application, following the same procedures as the active TENS group, also for 35 minutes.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TENS

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TENS - eletric pulse generator

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Primary dysmenorrhoea
* Moderate to severe pain

Exclusion Criteria

* Secondary dysmenorrhea
* Users of intrauterine device
* Cognitive impairment
* Failure to appear for treatment
* Pacemaker use
* Illicit drug use
* Epilepsy
* Skin problems
* Use of pain medication before the application of TENS
Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidade Federal de Sao Carlos

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fabio Mendes Camilo

Methodological Proposal of Application of Electrical Neurostimulation Transcutaneous (Comparative Study between Proposed Method of Application Versus Traditional method in patients with Primary Dysmenorrhea).

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fábio M. Camilo, teacher

Role: PRINCIPAL_INVESTIGATOR

Fundação de Educação e Cultura de Santa Fé do Sul

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

036/2010

Identifier Type: OTHER

Identifier Source: secondary_id

UFSaoCarlos0001/14

Identifier Type: -

Identifier Source: org_study_id