Transcutaneous Electrical Nerve StimulationNCT03198377
The Effect of Frequency Modulation in TENS on Habituation and Pain Threshold
A study testing TENS: Randomized frequency modulation, TENS: Scan 6/6 of frequency modulation and TENS: Fixed frequency in people with Transcutaneous Electrical Nerve Stimulation, run by University of Castilla-La Mancha at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcutaneous Electrical Nerve Stimulation
- What is being tested?
- TENS: Randomized frequency modulation, TENS: Scan 6/6 of frequency modulation and TENS: Fixed frequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jul 2017to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants will be volunteer healthy students of University of Castilla - La Mancha, older than 18 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- TENS: Randomized frequency modulation, TENS: Scan 6/6 of frequency modulation, TENS: Fixed frequency, Sham Stimulation
- Keywords
- Pain Threshold, Transcutaneous Electrical Nerve Stimulation, Habituation
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS: Randomized frequency modulationDevice
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 modulationDevice
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 frequencyDevice
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 StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TENS: Randomized frequency modulation | Experimental | TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) Receives: 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) Receives: 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) Receives: 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) Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: at 10 min. post-treatment
Secondary outcomes (5)
Mechanical pain threshold
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.
Measured: Baseline
Mechanical pain threshold
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.
Measured: during treatment at 15 min.
Mechanical pain threshold
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.
Measured: at 10 min. post-treatment
Perception current comfortability
Visual scale from 0 mm to 100 mm
Measured: at 1min. post-treatment
Perception current habituation
Visual scale from 0 mm to 100 mm
Measured: at 1min. post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start3 Jul 2017
- Primary completion5 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transcutaneous Electrical Nerve StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Avendaño-Coy, PhD, Study director, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198377
- Sponsor's protocol ID
- UCastillaLaMancha
- Status last verified
- Jul 2017
- First submitted
- 23 May 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30921466
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03198377
- Acronym / sponsor ID
- UCastillaLaMancha
- Keywords
- Pain Threshold, Transcutaneous Electrical Nerve Stimulation, Habituation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 5 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TENS: Randomized frequency modulation | Experimental | Device: TENS: Randomized frequency modulationTENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) |
| TENS: Scan 6/6 of frequency modulation | Experimental | Device: TENS: Scan 6/6 of frequency modulationTENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) |
| TENS: Fixed frequency | Experimental | Device: TENS: Fixed frequencyTENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) |
| TENS: Sham stimulation | Sham comparator | Device: Sham StimulationSham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants will be volunteer healthy students of University of Castilla - La Mancha, older than 18 years.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENS: Randomized frequency modulationTranscutaneous 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 | Device | TENS: Randomized frequency modulation |
| TENS: Scan 6/6 of frequency modulationTranscutaneous 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 | Device | TENS: Scan 6/6 of frequency modulation |
| TENS: Fixed frequencyTranscutaneous 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 | Device | TENS: Fixed frequency |
| Sham StimulationElectrodes 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. | Device | TENS: Sham stimulation |
Primary outcome
Habituation to electrical stimulation
Time frame: Baseline
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)
Habituation to electrical stimulation
Time frame: during treatment at 15 min
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)
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)
5 secondary outcomes
Mechanical pain threshold
Time frame: Baseline
Mechanical pain threshold
Time frame: during treatment at 15 min.
Mechanical pain threshold
Time frame: at 10 min. post-treatment
Perception current comfortability
Time frame: at 1min. post-treatment
Perception current habituation
Time frame: at 1min. post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Derived from this study: PubMed 30921466Avendano-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.
- Individual participant dataSharing planned: No
Related trials for Transcutaneous Electrical Nerve Stimulation
Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
Not yet recruiting
Parasacral TENS Project
Overactive Bladder (OAB), Lower Urinary Tract Dysfunction
Recruiting
Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea
Obstructive Sleep Apnea
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Avendaño-Coy, PhD study director
University of Castilla-La Mancha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS: Randomized frequency modulation, TENS: Scan 6/6 of frequency modulation and TENS: Fixed frequency in people with Transcutaneous Electrical Nerve Stimulation, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Habituation to electrical stimulation (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03198377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.