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| Name | Class |
|---|---|
| Hospital Nacional de Parapléjicos de Toledo | OTHER |
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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
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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal TENS | Device | Spinal TENS stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | At the end (40min) of the Spinal TENS session |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline at 0min |
| Baseline Maximal peak-to-peak soleus M wave |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julio Gómez-Soriano, PhD | Contact | 0034 925268800 | 5845 | Julio.Soriano@uclm.es |
| Name | Affiliation | Role |
|---|---|---|
| Juan Avendaño-Coy, PhD | University of Castilla-La Mancha | Study Director |
| Diego Serrano-Muñoz, MsC | Hospital Nacional de Parapléjicos de Toledo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juan Avendaño-Coy | Recruiting | Toledo | 45071 | Spain |
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Randomized, double-blind, placebo-controlled, crossover trial
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| Sham stimulation | Device | Sham stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands) |
|
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |