The Effect of Frequency Modulation in TENS on Habituation and Pain Threshold
NCT ID: NCT03198377
Last Updated: 2017-11-14
Study Results
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Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2017-07-03
2017-09-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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TENS: Randomized frequency modulation
TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
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
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)
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
TENS: Fixed frequency
TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
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
TENS: Sham stimulation
Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
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.
Interventions
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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
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
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 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
18 Years
30 Years
ALL
Yes
Sponsors
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University of Castilla-La Mancha
OTHER
Responsible Party
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Principal Investigators
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Juan Avendaño-Coy, PhD
Role: STUDY_DIRECTOR
University of Castilla-La Mancha
Locations
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Juan Avendaño-Coy
Toledo, , Spain
Countries
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References
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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.
Other Identifiers
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UCastillaLaMancha
Identifier Type: -
Identifier Source: org_study_id