Overview

This trial is active, not recruiting.

Condition spasticity
Treatments transcutaneous electrical stimulation, 10kilohertz (khz), sham stimulation
Sponsor University of Castilla-La Mancha
Start date December 2014
End date March 2016
Trial size 24 participants
Trial identifier NCT02718989, ddsm25

Summary

The purpose of this study is to determinate whether the application of electric currents produce changes in the excitability of alpha moto neurone. Moreover evidence whether the effect of the electric currents can change the tone of the muscle under stimulation in healthy volunteers

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Transcutaneous application of 10 Kilohertz (KHz) 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.
transcutaneous electrical stimulation TENS
TENS transcutaneous electrical stimulation over the back the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
10kilohertz (khz)
10 KHz transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
(Experimental)
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. Currents parameters are frequency 100 Hz and pulse width 100 microseconds
transcutaneous electrical stimulation TENS
TENS transcutaneous electrical stimulation over the back the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
(Sham Comparator)
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.
sham stimulation
Sham transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Primary Outcomes

Measure
Baseline H reflex
time frame: baseline at 0 min.
During treatment H reflex
time frame: During treatment at 33min.
Post treatment H reflex
time frame: Immediately after treatment at 40 min.

Secondary Outcomes

Measure
Baseline muscle tone
time frame: Baseline at 0 min.
Muscle tone during treatment
time frame: During treatment at 35 min.
Muscle tone post-treatment
time frame: Post-treatment at 42min

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Modulation of H-reflex After Application of Electric Currents in Healthy People. Effects on Myotonometer Properties.A Pilot Study
Principal investigator Diego Serrano-Muñoz, MsC
Description In the last years several experimental studies have evidenced that the transcutaneous electric nerve stimulation (TENS) in peripheric application can cause a decrease of spasticity and modulation of H-reflexes. But if the application is in the central nervous system the results are different. So the purpose of this study is quantify the modulation of the excitability of alpha moto neurone when the application of the current is in the central nervous system compared with a sham group.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Castilla-La Mancha.