Therapist-dependent Dose of Spinal TENS

Spinal Cord Stimulation Clinical Trial

Official title:

Intensity Matters: Therapist-dependent Dose of Spinal Transcutaneous Electrical Nerve Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03179488
• Other study ID #: ddsm22
• Status: Recruiting
• Phase: N/A
• First received: June 5, 2017
• Last updated: July 3, 2017
• Start date: July 3, 2017
• Est. completion date: August 2017

Study information

• Verified date: June 2017
• Source: University of Castilla-La Mancha
• Contact: Julio Gómez-Soriano, PhD
• Phone: 0034 925268800
• Email: Julio.Soriano[@]uclm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dose-response Relationship
• Spinal Cord Stimulation
• Transcutaneous Electrical Nerve Stimulation

Intervention

Device:
• Spinal TENS
Spinal TENS stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
• Sham stimulation
Sham stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Locations

Country	Name	City	State
Spain	Juan Avendaño-Coy	Toledo

Sponsors (2)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	Hospital Nacional de Parapléjicos de Toledo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Baseline Maximal peak-to-peak soleus M wave	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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