- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03179488
Therapist-dependent Dose of Spinal TENS
July 3, 2017 updated by: University of Castilla-La Mancha
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Julio Gómez-Soriano, PhD
- Phone Number: 5845 0034 925268800
- Email: julio.soriano@uclm.es
Study Locations
-
-
-
Toledo, Spain, 45071
- Recruiting
- Juan Avendaño-Coy
-
Contact:
- Juan Avendaño-Coy, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers between 18 and 60 years old
Exclusion Criteria:
- 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
- Neurotrauma
- Recent surgical procedures
- Pain affecting the lower limbs or lower back
- Diabetes
- Pregnancy
- Cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Spinal TENS stimulation
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.
|
Spinal TENS stimulation over back through the electrotherapy device Myomed 932.
(Enraf-Nonius, Delft, Netherlands)
|
Sham Comparator: Sham stimulation
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.
|
Sham stimulation over back through the electrotherapy device Myomed 932.
(Enraf-Nonius, Delft, Netherlands)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
At the onset (0min) of the Spinal TENS session
|
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)
|
At the end (40min) of the Spinal TENS session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Maximal peak-to-peak soleus H-reflex
Time Frame: baseline at 0min
|
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.
|
baseline at 0min
|
Baseline Maximal peak-to-peak soleus M wave
Time Frame: baseline at 0min
|
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.
|
baseline at 0min
|
Baseline Normalized H-reflex response
Time Frame: baseline at 0min
|
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.
|
baseline at 0min
|
During Maximal peak-to-peak soleus H-reflex
Time Frame: during treatment at 33min
|
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.
|
during treatment at 33min
|
During Maximal peak-to-peak soleus M wave
Time Frame: during treatment at 33min
|
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.
|
during treatment at 33min
|
During Normalized H-reflex response
Time Frame: during treatment at 33min
|
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.
|
during treatment at 33min
|
Post-treatment Maximal peak-to-peak soleus H-reflex
Time Frame: Immediately after treatment at 40 min
|
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.
|
Immediately after treatment at 40 min
|
Post-treatment Maximal peak-to-peak soleus M wave
Time Frame: Immediately after treatment at 40 min
|
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.
|
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
|
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.
|
Immediately after treatment at 40 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Juan Avendaño-Coy, PhD, University of Castilla-La Mancha
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 3, 2017
Primary Completion (Anticipated)
August 1, 2017
Study Completion (Anticipated)
August 1, 2017
Study Registration Dates
First Submitted
June 5, 2017
First Submitted That Met QC Criteria
June 5, 2017
First Posted (Actual)
June 7, 2017
Study Record Updates
Last Update Posted (Actual)
July 5, 2017
Last Update Submitted That Met QC Criteria
July 3, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- ddsm22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Stimulation
-
Case Western Reserve UniversityCompletedSpinal Cord Stimulation | High-frequency Stimulation | High-density StimulationUnited States
-
Spine Care, OklahomaCompletedSpinal Cord StimulationUnited States
-
Fondation Ophtalmologique Adolphe de RothschildRecruitingSpinal Cord StimulationFrance
-
Jocelyne BlochEcole Polytechnique Fédérale de LausanneRecruitingDeep Brain Stimulation | Neuro: Spinal Cord InjurySwitzerland
-
Jill M. Wecht, Ed.D.Icahn School of Medicine at Mount SinaiRecruitingBlood Pressure | Spinal Cord Injuries | SCI - Spinal Cord Injury | Blood Pressure Disorders | Traumatic Spinal Cord Injury | Acute Spinal Cord Injury | Neuromodulation | Spinal Cord StimulationUnited States
-
Spinal Cord Injury Centre of Western DenmarkUniversity of Southern DenmarkCompletedTranscranial Magnetic Stimulation | Rehabilitation | Spinal Cord Injury | NeurorehabilitationDenmark
-
University Hospital TuebingenRecruitingInsulin Secretion | Spinal Cord StimulationGermany
-
University of LouisvilleNational Heart, Lung, and Blood Institute (NHLBI)RecruitingRehabilitation | Spinal Cord Injuries | Breathing Exercises | Spinal Cord StimulationUnited States
-
MedtronicNeuroCompletedDeep Brain Stimulation | Spinal Cord Stimulation | Sacral Neuromodulation | Drug Infusion (Implantable Pumps)United States, France, Spain, Germany, United Kingdom, Italy, Austria
-
Amol SoinCompletedPain | Pain, Back | Spinal Cord StimulationUnited States
Clinical Trials on Spinal TENS
-
Mount Sinai Hospital, CanadaThe Arthritis Society, CanadaCompletedDegenerative Lumbar Spinal StenosisCanada
-
University of IoanninaCompletedChronic Low Back Pain
-
University of Sao Paulo General HospitalRecruiting
-
University of Sao Paulo General HospitalCompletedOveractive Bladder SyndromeBrazil
-
National Yang Ming UniversityRecruitingElectroencephalography | Transcutaneous Electrical Nerve Stimulation | Pressure Pain ThresholdTaiwan
-
Universidade Federal de Sao CarlosCompleted
-
University of MiamiNational Institute on Disability, Independent Living, and Rehabilitation...Terminated
-
University Hospital Inselspital, BerneArco FoundationCompletedOsteoarthritis, KneeSwitzerland
-
Universidad Rey Juan CarlosUnknownLateral Epicondylitis | Tennis ElbowSpain
-
Fondation LenvalRecruitingEnuresis, NocturnalFrance