Electrical Currents on Hypoalgesia

January 23, 2018 updated by: Fabio Massao Matuzawa

Hypoalgesic Effect of Low Frequency and Burst Modulated Alternating Currents on Healthy Individuals.

The objective of this study is to compare the hypoalgesic effects of TENS, Interferential current and Aussie current in pressure pain threshold and sensory discomfort in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 17580-970
        • CPA Pompéia UNIP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • health adults

Exclusion Criteria:

  • injury to nerves of the upper limbs, pain, pregnancy, chronic diseases, cardiac pacemaker, epilepsy, allergy to the electrode used, use of pain medication, skin lesions or lack of sensitivity in the areas of electrode placement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
This group will not receive electrical stimulation. Volunteers will rest during 30 minutes.
Active Comparator: Interferential current group
Interferential current will be applied during 30 minutes to volunteer's forearm. Intensity will be increase until volunteers fell a strong but comfortable paresthesia.
Device: Interferential current
Interferential current will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Carrier frequency will be set at 4 kilohertz (kHz) and modulated frequency will be set at 100 Hz.
Active Comparator: TENS Group
TENS will be applied during 30 minutes to volunteer's forearm. Intensity will be increase until volunteers fell a strong but comfortable paresthesia.
Device: TENS
TENS will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Pulse duration will be set at 125 microseconds and frequency will be set at 100 Hz.
Active Comparator: Aussie current group
Aussie current will be applied during 30 minutes to volunteer's forearm. Intensity will be increase until volunteers fell a strong but comfortable paresthesia.
Device: Aussie Current
Aussie current will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Carrier frequency will be set at 4 kHz and modulated frequency will be set at 100 Hz.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure Pain Threshold
Time Frame: Baseline, 15 minutes after the beginning of electrical stimulation, 30 minutes after the beginning of electrical stimulation, and 20 minutes after electrical stimulation.
Pressure Pain Threshold will be measured using a digital pressure algometer SOMEDIC type II. The applied force will be measured in Newton (N).
Baseline, 15 minutes after the beginning of electrical stimulation, 30 minutes after the beginning of electrical stimulation, and 20 minutes after electrical stimulation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory Discomfort
Time Frame: 15 and 30 minutes after the beginning of electrical stimulation.
Sensory Discomfort will be measured using a 10 cm visual analogue scale (VAS). The degree of discomfort will be measured in centimeters (cm).
15 and 30 minutes after the beginning of electrical stimulation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fabio Massao Matuzawa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2017

Primary Completion (Actual)

December 18, 2017

Study Completion (Actual)

January 23, 2018

Study Registration Dates

First Submitted

September 23, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimate)

September 25, 2013

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14571013.1.0000.5512

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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