Dose-response Relationship, Spinal Cord Stimulation, Transcutaneous Electrical Nerve Stimulation
Conditions
Brief 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
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.
Interventions
DEVICESpinal TENS
Spinal TENS stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
DEVICESham stimulation
Sham stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Sponsors
Hospital Nacional de Parapléjicos de Toledo
University of Castilla-La Mancha
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized, double-blind, placebo-controlled, crossover trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Current Density | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Maximal peak-to-peak soleus M wave | 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. |
| During Maximal peak-to-peak soleus H-reflex | 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 Maximal peak-to-peak soleus M wave | 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. |
| Baseline Normalized H-reflex response | 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. |
| Post-treatment Maximal peak-to-peak soleus H-reflex | 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. |
| Post-treatment Maximal peak-to-peak soleus M wave | 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. |
| Post-treatment Normalized H-reflex responseMaximal peak-to-peak soleus H-reflex | 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. |
| During Normalized H-reflex response | 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. |
| Baseline Maximal peak-to-peak soleus H-reflex | 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. |
Countries
Spain
Contacts
Primary ContactJulio Gómez-Soriano, PhD
Outcome results
None listed