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

Not Applicable

Completed

• Conditions: Transcutaneous Electrical Nerve Stimulation
• Interventions: Device: Sham Stimulation

• Registration Number: NCT03198377
• Lead Sponsor: University of Castilla-La Mancha

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.

Study Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-26
• Status Verified: 2017-07
• Study Start: 2017-07-03
• Primary Completion: 2017-09-05
• Study Completion: 2017-09-30
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TENS: Sham stimulation	Sham Stimulation	Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Primary Outcome Measures

Name	Time	Method
Habituation to electrical stimulation	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 Outcome Measures

Name	Time	Method
Perception current comfortability	at 1min. post-treatment	Visual scale from 0 mm to 100 mm
Mechanical pain threshold	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.
Perception current habituation	at 1min. post-treatment	Visual scale from 0 mm to 100 mm

Trial Locations

Locations (1)

Juan Avendaño-Coy; 🇪🇸 Toledo, Spain