The Effect of Frequency Modulation in TENS on Habituation and Pain Threshold

November 13, 2017 updated by: University of Castilla-La Mancha

The Effect of Frequency Modulation in Transcutaneous Electrical Nerve Stimulation (TENS) on Habituation and Pain Threshold: a Randomized, Double Blind, Controlled Cross-over

Purpose

The purpose of this study is to determine whether application of Transcutaneous Electrical Nerve Stimulation (TENS) is effective on habituation to electrical current whether delivered at a fixed frequency of 100 Hz or at patterned frequency. The secondary purposes are to determine the effectiveness on mechanical pressure pain and the subjective perception of the subjects regarding habituation and comfort of the different stimulations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Low frequency and low intensity TENS showed strong evidence of inefficiency while conventional high frequency TENS (around 100Hz) applied at "strong but comfortable" intensity proved strong evidence of efficacy on pressure pain. In addition, some studies have shown the importance of current intensity in the effect of TENS.

Either in clinical practice and in research, TENS intensity is usually adjusted according to the sensation of the subjects "strong but comfortable" "strong just below the motor threshold", ...). Usually throughout the TENS applications there is a phenomenon called "habituation" that involve a wide decrease of the sensation of the current applied, even though the perception the output-parameters are maintained.

In this sense, It has been seem that adjusting the intensity throughout the TENS intervention produced a greater hypoalgesic effect than when the intensity remained fixed.

On the other hand, most TENS devices offer the possibility of modulating current with the aim of preventing habituation phenomenon. The modulation of the electric current consists of changing the characteristics of the current (pulse width, pulse frequency, ...) every few seconds during the intervention. Nevertheless, the most common pattern used is the frequency modulation. However, there is a lack of evidence regarding what it is the better methods to avoid habituation during a TENS application.

Study Type

Interventional

Enrollment (Actual)

39

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

  • Spain
      • Toledo, Spain, 45071
        • Juan Avendaño-Coy

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

16 years to 28 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants will be volunteer healthy students of University of Castilla - La Mancha, older than 18 years.

Exclusion Criteria:

  • Neuromuscular disease. Epilepsy. Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area.

Osteosynthesis material in the upper limb. Cancer. Cardiovascular disease. Pacemaker or other implanted electrical device. Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.

Presence of tattoos or other external agent introduced into the treatment or assessment area.

Pregnancy. Sensitivity disturbance in upper limb.

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TENS: Randomized frequency modulation
TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Device: TENS: Randomized frequency modulation

Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold. Currents parameters are:

Frequency modulation: randomized pattern (from 80 to 120 Hz) Pulse width 200 microseconds
Experimental: TENS: Scan 6/6 of frequency modulation
TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Device: TENS: Scan 6/6 of frequency modulation

Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold. Currents parameters are:

Frequency modulation: Scan of frequency from 80 to 120 Hz in 6/6 mode (frequency sweep from 80 Hz to 120 Hz in 6 seconds and from 120 to 80 Hz in 6 secons) Pulse width 200 microseconds
Experimental: TENS: Fixed frequency
TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Device: TENS: Fixed frequency

Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a "strong but comfortable" sensation, just below motor threshold. Currents parameters are:

Fixed frequency at 100 Hz Pulse width 200 microseconds
Sham Comparator: TENS: Sham stimulation
Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Device: Sham Stimulation
Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Habituation to electrical stimulation
Time Frame: Baseline
Due to habituation it is necessary to increase the intensity of the current throughout the session. Two measures were recorded within this variable: i) the increase in current density (mA / cm2) throughout the session (difference between its initial frequency and final frequency value of the current) and the number of times the participant requested to increase the intensity (subjects were instructed to maintain the same threshold)
Baseline
Habituation to electrical stimulation
Time Frame: during treatment at 15 min
Due to habituation it is necessary to increase the intensity of the current throughout the session. Two measures were recorded within this variable: i) the increase in current density (mA / cm2) throughout the session (difference between its initial frequency and final frequency value of the current) and the number of times the participant requested to increase the intensity (subjects were instructed to maintain the same threshold)
during treatment at 15 min
Habituation to electrical stimulation
Time Frame: at 10 min. post-treatment
Due to habituation it is necessary to increase the intensity of the current throughout the session. Two measures were recorded within this variable: i) the increase in current density (mA / cm2) throughout the session (difference between its initial frequency and final frequency value of the current) and the number of times the participant requested to increase the intensity (subjects were instructed to maintain the same threshold)
at 10 min. post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical pain threshold
Time Frame: Baseline
The pressure pain threshold will be measured by a pressure digital algometer (Wagner Instruments, FDIX. Post Office Box 1217, Greenwich, CT 06836-1217 USA.) and will be expressed in Newton; on the back of the right hand (about 3 cm from the first interdigital foldand) . The mechanical pain threshold will be assessed 3 time in order to calculate the mean value.
Baseline
Mechanical pain threshold
Time Frame: during treatment at 15 min.
The pressure pain threshold will be measured by a pressure digital algometer (Wagner Instruments, FDIX. Post Office Box 1217, Greenwich, CT 06836-1217 USA.) and will be expressed in Newton; on the back of the right hand (about 3 cm from the first interdigital foldand) . The mechanical pain threshold will be assessed 3 time in order to calculate the mean value.
during treatment at 15 min.
Mechanical pain threshold
Time Frame: at 10 min. post-treatment
The pressure pain threshold will be measured by a pressure digital algometer (Wagner Instruments, FDIX. Post Office Box 1217, Greenwich, CT 06836-1217 USA.) and will be expressed in Newton; on the back of the right hand (about 3 cm from the first interdigital foldand) . The mechanical pain threshold will be assessed 3 time in order to calculate the mean value.
at 10 min. post-treatment
Perception current comfortability
Time Frame: at 1min. post-treatment
Visual scale from 0 mm to 100 mm
at 1min. post-treatment
Perception current habituation
Time Frame: at 1min. post-treatment
Visual scale from 0 mm to 100 mm
at 1min. post-treatment

Collaborators and Investigators

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

Sponsor

University of Castilla-La Mancha

Investigators

  • Study Director: Juan Avendaño-Coy, PhD, University of Castilla-La Mancha

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)

July 3, 2017

Primary Completion (Actual)

September 5, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

June 22, 2017

First Posted (Actual)

June 26, 2017

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 13, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UCastillaLaMancha

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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