MedPath

Evaluation of Pressure Sense Threshold and Tactile Sensation After Lidocaine Iontophoresis Using Interferential Current

Phase 2
Completed
Conditions
Interferential Current Drug Delivery
Interventions
Device: interferential current
Device: iontophoresis of Lidocaine 10% with interferential current (Dynatron 438)
Registration Number
NCT02487914
Lead Sponsor
Shiraz University of Medical Sciences
Brief Summary

Drug delivery is conducted through various methods such as injection, phonophoresis, and iontophoresis. Iontophoresis is defined as the noninvasive delivery of active ions through epidermis using direct current. The direct current has some disadvantages such as skin burning and limited time of application. Interferential current is a kind of alternating currents without limitations of direct current; so the purpose of this study was to investigate and compare the effects of Lidocaine, interferential current and Lidocaine iontophoresis using interferential current.

Detailed Description

Pressure, tactile, and pain thresholds were evaluated before and after the application of Lidocaine, interferential current and Lidocaine iontophoresis using interferential current. Pressure threshold was investigated with a Pesula. Pesula is a pen-like scaled mechanical device that measures the skin pressure threshold. Pesula was pressed to the skin and pressure threshold was measured in mm. Pain and tactile thresholds were investigated using an electrical stimulator.The intensity was gradually increased to the extent that the participant reported a tingling sensation. The displayed intensity was considered as the tactile sense threshold. Then, the intensity was increased to the extent to be intolerable for the participant and this intensity was considered as the maximum pain threshold. The thresholds were recorded in milliampere.

Lidocaine iontophoresis using interferential current can increase perception threshold of pain, and pressure sense more significantly in comparison to the application of Lidocaine and interferential current alone.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
30
Inclusion Criteria
  • healthy women with age between 18 and 25 years old
Exclusion Criteria
  • Systemic disorders,
  • neuro-muscular diseases such as diabetes and all forms of neuropathies,
  • and use of narcoleptic drugs which may contaminate the results.
  • Also, none of the participants were on their menstrual cycle.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
interferential currentinterferential currentthe threshold of pressure, tactile,and pain thresholds were evaluated after the application of interferential current.
lidocaine iontophoresis using interferential currentiontophoresis of Lidocaine 10% with interferential current (Dynatron 438)the threshold of pressure, tactile,and pain thresholds were evaluated after the iontophoresis of Lidocaine using interferential current.
lidocaineLidocaine 10% was sprayed at the identified regionthe threshold of pressure, tactile,and pain thresholds were evaluated after the application of topical Lidocaine.
Primary Outcome Measures
NameTimeMethod
pain threshold- evaluated by increasing intensity of interferential current.up to one week

pain threshold to increasing intensity of interferential current.

Secondary Outcome Measures
NameTimeMethod
tactile threshold- evaluated by exact perception of the lowest level of interferential currentup to one week

exact perception of the lowest level of interferential current

pressure threshold- evaluated by Pesulaup to one week

Pesula was used to evaluate tactile threshold.

Trial Locations

Locations (1)

School of Rehabilitation

🇮🇷

Shiraz, Fars, Iran, Islamic Republic of

© Copyright 2025. All Rights Reserved by MedPath