Clinical trial NCT03198377: The Effect of Frequency Modulation in TENS on Habituation and Pain Threshold
Official title: The Effect of Frequency Modulation in Transcutaneous Electrical Nerve Stimulation (TENS) on Habituation and Pain Threshold: a Randomized, Double Blind, Controlled Cross-over
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transcutaneous Electrical Nerve Stimulation
Keywords: Pain Threshold
Transcutaneous Electrical Nerve Stimulation
Habituation
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Habituation to electrical stimulation
timeFrame: Baseline
measure: Habituation to electrical stimulation
timeFrame: during treatment at 15 min
measure: Habituation to electrical stimulation
timeFrame: at 10 min. post-treatment
Secondary outcomes:
measure: Mechanical pain threshold
timeFrame: Baseline
measure: Mechanical pain threshold
timeFrame: during treatment at 15 min.
measure: Mechanical pain threshold
timeFrame: at 10 min. post-treatment
measure: Perception current comfortability
timeFrame: at 1min. post-treatment
measure: Perception current habituation
timeFrame: at 1min. post-treatment
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Juan Avendaño-Coy
Study officials:
affiliation: University of Castilla-La Mancha
name: Juan Avendaño-Coy, PhD
role: STUDY_DIRECTOR
References:
citation: Avendano-Coy J, Bravo-Esteban E, Ferri-Morales A, Martinez-de la Cruz R, Gomez-Soriano J. Does Frequency Modulation of Transcutaneous Electrical Nerve Stimulation Affect Habituation and Mechanical Hypoalgesia? A Randomized, Double-Blind, Sham-Controlled Crossover Trial. Phys Ther. 2019 Jul 1;99(7):924-932. doi: 10.1093/ptj/pzz054.