Importance of the Current Density in TENS

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

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

Study Overview

• Status: Completed
• Conditions: Spasticity
• Intervention / Treatment: Device: Sham stimulation; Device: TENS

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous nerve stimulation; 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; TENS transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
Sham Comparator: Sham stimulation; 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; Sham transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Investigators: Principal Investigator: Diego Serrano-Muñoz, MsC, Hospital Nacional de Parapléjicos de Toledo

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 3, 2016
• First Submitted That Met QC Criteria: March 18, 2016
• First Posted (Estimate): March 24, 2016

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: TENS; H-Reflex; Current Density
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: ddsm

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES