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Clinical Trials/NCT03198377
NCT03198377
Completed
Not Applicable

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

University of Castilla-La Mancha1 site in 1 country39 target enrollmentJuly 3, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transcutaneous Electrical Nerve Stimulation
Sponsor
University of Castilla-La Mancha
Enrollment
39
Locations
1
Primary Endpoint
Habituation to electrical stimulation
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 3, 2017
End Date
September 30, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
University of Castilla-La Mancha
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Perception current comfortability(at 1min. post-treatment)
  • Mechanical pain threshold(at 10 min. post-treatment)
  • Perception current habituation(at 1min. post-treatment)

Study Sites (1)

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