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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Iontophoresis Effects on Senses

Conditions
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Interferential Current Drug Delivery

Intervention / Treatment
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* Device: iontophoresis of Lidocaine 10% with interferential current (Dynatron 438)
* Drug: Lidocaine 10% was sprayed at the identified region
* Device: interferential current


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lidocaine iontophoresis using interferential current<br>the threshold of pressure, tactile,and pain thresholds were evaluated after the iontophoresis of Lidocaine using interferential current. | Device: iontophoresis of Lidocaine 10% with interferential current (Dynatron 438)<br>* drug delivery through interferential current.<br>* Other names: Dynatron 438, Enraf Nonius Comp., Netherlands;|
| Active Comparator: interferential current<br>the threshold of pressure, tactile,and pain thresholds were evaluated after the application of interferential current. | Device: interferential current<br> <br> * Other names: Dynatron 438, Enraf Nonius Comp., Netherlands;|
| Active Comparator: lidocaine<br>the threshold of pressure, tactile,and pain thresholds were evaluated after the application of topical Lidocaine. | Drug: Lidocaine 10% was sprayed at the identified region<br> <br> * Other names: Xylocaine 10% spray, AstraZeneca, Korea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain threshold- evaluated by increasing intensity of interferential current. | pain threshold to increasing intensity of interferential current. | up to one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tactile threshold- evaluated by exact perception of the lowest level of interferential current | exact perception of the lowest level of interferential current | up to one week | 
| pressure threshold- evaluated by Pesula | Pesula was used to evaluate tactile threshold. | up to one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure, Drug Delivery, Iontophoresis, Lidocaine, Tactile perception