Clinical trial NCT03179488: Therapist-dependent Dose of Spinal TENS
Official title: Intensity Matters: Therapist-dependent Dose of Spinal Transcutaneous Electrical Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transcutaneous Electrical Nerve Stimulation
Spinal Cord Stimulation
Dose-response Relationship
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Hospital Nacional de Parapléjicos de Toledo
First posted: 2017-06-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, placebo-controlled, crossover trial
Primary purpose: TREATMENT

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".

Eligibility criteria: 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

Primary outcomes:
measure: Baseline Current Density
timeFrame: At the onset (0min) of the Spinal TENS session
measure: Final Current Density
timeFrame: At the end (40min) of the Spinal TENS session
Secondary outcomes:
measure: Baseline Maximal peak-to-peak soleus H-reflex
timeFrame: baseline at 0min
measure: Baseline Maximal peak-to-peak soleus M wave
timeFrame: baseline at 0min
measure: Baseline Normalized H-reflex response
timeFrame: baseline at 0min
measure: During Maximal peak-to-peak soleus H-reflex
timeFrame: during treatment at 33min
measure: During Maximal peak-to-peak soleus M wave
timeFrame: during treatment at 33min
measure: During Normalized H-reflex response
timeFrame: during treatment at 33min
measure: Post-treatment Maximal peak-to-peak soleus H-reflex
timeFrame: Immediately after treatment at 40 min
measure: Post-treatment Maximal peak-to-peak soleus M wave
timeFrame: Immediately after treatment at 40 min
measure: Post-treatment Normalized H-reflex responseMaximal peak-to-peak soleus H-reflex
timeFrame: Immediately after treatment at 40 min
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Juan Avendaño-Coy
Study officials:
affiliation: University of Castilla-La Mancha
name: Juan Avendaño-Coy, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Nacional de Parapléjicos de Toledo
name: Diego Serrano-Muñoz, MsC
role: PRINCIPAL_INVESTIGATOR
References: