Application of Electrical Neurostimulation Transcutaneous in Patients With Primary Dysmenorrhea.

Primary Dysmenorrhea Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02205970
• Other study ID #: UFSaoCarlos0001/14
• Secondary ID: 036/2010
• Status: Completed
• Phase: N/A
• First received: July 28, 2014
• Last updated: October 19, 2017
• Start date: August 2010
• Est. completion date: July 2014

Study information

• Verified date: October 2017
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	participants will be monitored for 24 hours
Secondary	duration of analgesia after application	check the duration of analgesia after application of interactive TENS (proposed method)	1 week