Application of Electrical Neurostimulation Transcutaneous in Patients With Primary Dysmenorrhea.

Methodological Proposal of Application of Electrical Neurostimulation Transcutaneous (Comparative Study Between Proposed Method of Application Versus Traditional Method in Patients With Primary Dysmenorrhea).

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02205970

Enrollment

124

Registered

2014-08-01

Start date

2010-08-31

Completion date

2014-07-31

Last updated

2017-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Dysmenorrhea

Keywords

TENS, Dysmenorrhea, analgesia, interactive

Brief 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.

Detailed description

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

Interventions

DEVICETENS

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.

DEVICETENS (sham)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

one arm study

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 36 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
measure the pain threshold, used to Visual Analogue Scale (VAS)before and after application	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.

Secondary

Measure	Time frame	Description
duration of analgesia after application	1 week	check the duration of analgesia after application of interactive TENS (proposed method)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026