Importance of the Current Density in TENS

Sponsor
University of Castilla-La Mancha (Other)
Overall Status
Completed
CT.gov ID
NCT02718690
Collaborator
(none)
20
2
15

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: TENS
  • Device: Sham stimulation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Importance of the Current Density: Effects of TENS About H-reflex. A Pilot Study
Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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 Outcome Measures

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Castilla-La Mancha

Investigators

  • Principal Investigator: Diego Serrano-Muñoz, MsC, Hospital Nacional de Parapléjicos de Toledo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Castilla-La Mancha
ClinicalTrials.gov Identifier:
NCT02718690
Other Study ID Numbers:
  • ddsm
First Posted:
Mar 24, 2016
Last Update Posted:
Mar 24, 2016
Last Verified:
Mar 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by University of Castilla-La Mancha
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2016