Therapist-dependent Dose of Spinal TENS

Not Applicable

• Conditions: Spinal Cord Stimulation; Dose-response Relationship; Transcutaneous Electrical Nerve Stimulation
• Interventions: Device: Spinal TENS; Device: Sham stimulation

• Registration Number: NCT03179488
• Lead Sponsor: University of Castilla-La Mancha

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".

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-05
• Study First Submitted QC: 2017-06-05
• Study First Posted: 2017-06-07
• Study Start: 2017-07-03
• Last Update Submitted: 2017-07-03
• Last Update Posted: 2017-07-05
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Spinal TENS stimulation	Spinal TENS	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.
Sham stimulation	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Juan Avendaño-Coy; 🇪🇸 Toledo, Spain