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

NCT03198377 | Completed DMC

• 1 other identifier: UCastillaLaMancha
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcutaneous Electrical Nerve Stimulation

Keywords

Pain Threshold; Transcutaneous Electrical Nerve Stimulation; Habituation

Outcome Measures

Primary Outcomes (3)

• Habituation to electrical stimulation

  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

  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

  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 Outcomes (5)

• Mechanical pain threshold

  Baseline

• Mechanical pain threshold

  during treatment at 15 min.

• Mechanical pain threshold

  at 10 min. post-treatment

• Perception current comfortability

  at 1min. post-treatment

• Perception current habituation

  at 1min. post-treatment

Study Arms (4)

TENS: Randomized frequency modulation

EXPERIMENTAL

TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Device: TENS: Randomized frequency modulation

TENS: Scan 6/6 of frequency modulation

EXPERIMENTAL

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

TENS: Fixed frequency

EXPERIMENTAL

TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Device: TENS: Fixed frequency

TENS: Sham stimulation

SHAM COMPARATOR

Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Device: Sham Stimulation

Interventions

TENS: Randomized frequency modulation DEVICE

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

TENS: Randomized frequency modulation

TENS: Scan 6/6 of frequency modulation DEVICE

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

TENS: Scan 6/6 of frequency modulation

TENS: Fixed frequency DEVICE

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

TENS: Fixed frequency

Sham Stimulation DEVICE

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.

TENS: Sham stimulation

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

Juan Avendaño-Coy

Toledo, 45071, Spain

Location

Related Publications (1)

• 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.

  PMID: 30921466 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Juan Avendaño-Coy, PhD

  University of Castilla-La Mancha

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: June 26, 2017
• Study Start: July 3, 2017
• Primary Completion: September 5, 2017
• Study Completion: September 30, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)