Transcutaneous Electrical Nerve StimulationNCT03179488
Therapist-dependent Dose of Spinal TENS
A study testing Spinal TENS in people with Transcutaneous Electrical Nerve Stimulation and Spinal Cord Stimulation, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
The intensity used during transcutaneous electrical nerve stimulation (TENS) in both, clinical practice and research studies, is often based on subjective commands such as "strong but comfortable sensation". There is not consensus regarding the effectiveness dose of TENS Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcutaneous Electrical Nerve Stimulation, Spinal Cord Stimulation, Dose-response Relationship
- What is being tested?
- Spinal TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jul 2017to Aug 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers between 18 and 60 years old
Who cannot join
- Musculoskeletal pathology of the lower limbs
- History of neuromuscular disease
- Unable to tolerate electrical current
- Allergy to the electrode material
- Pacemaker or any implanted device
- Epilepsy
Show all 12Show fewer
- Neurotrauma
- Recent surgical procedures
- Pain affecting the lower limbs or lower back
- Diabetes
- Pregnancy
- Cancer
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Juan Avendaño-Coy
Toledo, 45071
Juan Avendaño-Coy, PhD
About this study
Official title: Intensity Matters: Therapist-dependent Dose of Spinal Transcutaneous Electrical Nerve Stimulation
The intensity used during transcutaneous electrical nerve stimulation (TENS) in both, clinical practice and research studies, is often based on subjective commands such as "strong but comfortable sensation". There is not consensus regarding the effectiveness dose of TENS
Read the detailed description
Twenty healthy volunteers will divide into two groups: Therapist 1 and Therapist 2. Both therapist will apply spinal TENS and sham stimulation for 40min in random order to each subject, at an intensity to produce a "strong but comfortable sensation".
- Conditions
- Transcutaneous Electrical Nerve Stimulation, Spinal Cord Stimulation, Dose-response Relationship
- Being tested
- Spinal TENS, Sham stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal TENSDevice
Spinal TENS stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Sham stimulationDevice
Sham stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
| Study group | Role | What they receive |
|---|---|---|
| Spinal TENS stimulation | Experimental | Spinal TENS stimulation: A constant voltage and a symmetric biphasic current of 200 microseg pulse-width at a frequency of 100Hz. The intensity will increase until participants report a "strong but comfortable" sensation, just below motor threshold. Receives: Device: Spinal TENS |
| Sham stimulation | Sham comparator | The same procedures as experimental group, but but will be applied a sham electrical stimulation increasing the current intensity until sensory perception of the stimulus, and then decreased to zero where it will fix until the end of the stimulation. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Current Density
Current density (mA/cm2) is obtained by a mathematical operation which reflects the applied current intensity divided by the electrode area (45cm2)
Measured: At the onset (0min) of the Spinal TENS session
Final Current Density
Current density (mA/cm2) is obtained by a mathematical operation which reflects the applied current intensity divided by the electrode area (45cm2)
Measured: At the end (40min) of the Spinal TENS session
Secondary outcomes (9)
Baseline Maximal peak-to-peak soleus H-reflex
H-reflex data are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
Measured: baseline at 0min
Baseline Maximal peak-to-peak soleus M wave
M wave ddata are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
Measured: baseline at 0min
Baseline Normalized H-reflex response
Normalized H-reflex response data are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
Measured: baseline at 0min
During Maximal peak-to-peak soleus H-reflex
H-reflex data are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
Measured: during treatment at 33min
During Maximal peak-to-peak soleus M wave
M wave data are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
Measured: during treatment at 33min
During Normalized H-reflex response
Normalized H-reflex response data are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
Measured: during treatment at 33min
Post-treatment Maximal peak-to-peak soleus H-reflex
H-reflex data are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
Measured: Immediately after treatment at 40 min
Post-treatment Maximal peak-to-peak soleus M wave
M wave data are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
Measured: Immediately after treatment at 40 min
Post-treatment Normalized H-reflex responseMaximal peak-to-peak soleus H-reflex
Normalized H-reflex response data are obtained by electromyography activity (EMG). The EMG electrode is fixed on triceps surae. The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa.
Measured: Immediately after treatment at 40 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start3 Jul 2017
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Randomized, double-blind, placebo-controlled, crossover trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo
- Responsible party
- Sponsor
- Investigators
- Juan Avendaño-Coy, PhD, Study director, University of Castilla-La ManchaDiego Serrano-Muñoz, MsC, Principal investigator, Hospital Nacional de Parapléjicos de Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179488
- Sponsor's protocol ID
- ddsm22
- Status last verified
- Jun 2017
- First submitted
- 5 Jun 2017
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensity Matters: Therapist-dependent Dose of Spinal Transcutaneous Electrical Nerve Stimulation
- ClinicalTrials.gov ID
- NCT03179488
- Acronym / sponsor ID
- ddsm22
- Conditions
- Transcutaneous Electrical Nerve Stimulation, Spinal Cord Stimulation, Dose-response Relationship
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Hospital Nacional de Parapléjicos de Toledo
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 7 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.
The intensity used during transcutaneous electrical nerve stimulation (TENS) in both, clinical practice and research studies, is often based on subjective commands such as "strong but comfortable sensation". There is not consensus regarding the effectiveness dose of TENS
Detailed description
Twenty healthy volunteers will divide into two groups: Therapist 1 and Therapist 2. Both therapist will apply spinal TENS and sham stimulation for 40min in random order to each subject, at an intensity to produce a "strong but comfortable sensation".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, crossover trial
| Arm | Type | Receives |
|---|---|---|
| Spinal TENS stimulation | Experimental | Device: Spinal TENSSpinal TENS stimulation: A constant voltage and a symmetric biphasic current of 200 microseg pulse-width at a frequency of 100Hz. The intensity will increase until participants report a "strong but comfortable" sensation, just below motor threshold. |
| Sham stimulation | Sham comparator | Device: Sham stimulationThe same procedures as experimental group, but but will be applied a sham electrical stimulation increasing the current intensity until sensory perception of the stimulus, and then decreased to zero where it will fix until the end of the stimulation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers between 18 and 60 years old
Key exclusion criteria (12 listed)
- Musculoskeletal pathology of the lower limbs
- History of neuromuscular disease
- Unable to tolerate electrical current
- Allergy to the electrode material
- Pacemaker or any implanted device
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 |
|---|---|---|
| Spinal TENSSpinal TENS stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) | Device | Spinal TENS stimulation |
| Sham stimulationSham stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) | Device | Sham stimulation |
Primary outcome
Baseline Current Density
Time frame: At the onset (0min) of the Spinal TENS session
Current density (mA/cm2) is obtained by a mathematical operation which reflects the applied current intensity divided by the electrode area (45cm2)
Final Current Density
Time frame: At the end (40min) of the Spinal TENS session
Current density (mA/cm2) is obtained by a mathematical operation which reflects the applied current intensity divided by the electrode area (45cm2)
9 secondary outcomes
Baseline Maximal peak-to-peak soleus H-reflex
Time frame: baseline at 0min
Baseline Maximal peak-to-peak soleus M wave
Time frame: baseline at 0min
Baseline Normalized H-reflex response
Time frame: baseline at 0min
During Maximal peak-to-peak soleus H-reflex
Time frame: during treatment at 33min
During Maximal peak-to-peak soleus M wave
Time frame: during treatment at 33min
During Normalized H-reflex response
Time frame: during treatment at 33min
Post-treatment Maximal peak-to-peak soleus H-reflex
Time frame: Immediately after treatment at 40 min
Post-treatment Maximal peak-to-peak soleus M wave
Time frame: Immediately after treatment at 40 min
Post-treatment Normalized H-reflex responseMaximal peak-to-peak soleus H-reflex
Time frame: Immediately after treatment at 40 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
- Individual participant dataSharing planned: No
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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
Diego Serrano-Muñoz, MsC principal investigator
Hospital Nacional de Parapléjicos de Toledo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal TENS in people with Transcutaneous Electrical Nerve Stimulation and Spinal Cord 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 12 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: status not confirmed, as of the sponsor's last update on 5 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julio Gómez-Soriano, PhD (0034 925268800 ext. 5845, Julio.Soriano@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Current Density (time frame: At the onset (0min) of the Spinal TENS session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2017.