Importance of the Current Density in TENS

Study Overview
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Brief Summary
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The purpose of this study is demonstrate the importance of density current of TENS in the effect about H-reflex in healthy volunteers.

Detailed Description
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TENS have been used to treatment against pain and reflex modulation. However, the most part of evidence do not show the current density. This parameter has been demonstrated like a important factor in the effect of the current about the outcome measures. This study show the difference between the same subjective sensation strong but comfortable in current density and the relation with the effect about H-reflex.

Official Title
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Importance of the Current Density: Effects of TENS About H-reflex. A Pilot Study

Conditions
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Spasticity

Intervention / Treatment
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* Device: TENS
* Device: Sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will be volunteer healthy students of Physiotherapy, University of Castilla - La Mancha, older than 18 years. Exclusion Criteria: Neuromuscular disease. Epilepsy. Trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area. Osteosynthesis material in the upper limb. Diabetes. 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 lower limb.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous nerve stimulation<br>Transcutaneous application of TENS current over the back for a 40 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold. | Device: TENS<br>* TENS transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)<br>|
| Sham Comparator: Sham stimulation<br>Electrodes are placed over the back for a 40 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: Sham stimulation<br>* Sham transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline H reflex | H-reflex data are obtained by EMG signal. The EMG electrode (SignalConditioningElectrodes v2.3, Delsys Inc., USA) is fixed on triceps surae by the SENIAM protocol (www.seniam.org). The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa. | baseline at 0 min. | 
| During treatment H reflex | H-reflex data are obtained by EMG signal. The EMG electrode (SignalConditioningElectrodes v2.3, Delsys Inc., USA) is fixed on triceps surae by the SENIAM protocol (www.seniam.org). The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa. | During treatment at 33min. | 
| Post-treatment H reflex | H-reflex data are obtained by EMG signal. The EMG electrode (SignalConditioningElectrodes v2.3, Delsys Inc., USA) is fixed on triceps surae by the SENIAM protocol (www.seniam.org). The stimulator electrode is fixed on the peroneus nerve, in the popliteal fossa. | Immediately after treatment at 40 min. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Current Density | Current density (mA/cm2) is obtained by a mathematical operation. It is the result of the quotient between the current intensity by the area of the electrodes (in this case 45cm²). | At 1 min. treatment session, at 40 min. treatment session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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H-Reflex, Current Density, TENS