Importance of the Current Density in TENS

Spasticity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02718690
• Other study ID #: ddsm
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Castilla-La Mancha

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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