Importance of the Current Density in TENS

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02718690

Enrollment

Registered

2016-03-24

Start date

2014-12-31

Completion date

2016-03-31

Last updated

2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spasticity

Keywords

H-Reflex, Current Density, TENS

Brief summary

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

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.

Interventions

DEVICETENS

TENS transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

DEVICESham stimulation

Sham transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Baseline H reflex	baseline at 0 min.	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 H reflex	During treatment at 33min.	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.
Post-treatment H reflex	Immediately after treatment at 40 min.	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.

Secondary

Measure	Time frame	Description
Change Current Density	At 1 min. treatment session, at 40 min. treatment session	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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026