A Phase 2/3 interventional study of iontophoresis of Lidocaine 10% with interferential current (Dynatron 438) and Lidocaine 10% was sprayed at the identified region in Interferential Current Drug Delivery, sponsored by Shiraz University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-02.
Sponsored by Shiraz University of Medical Sciences · Phase 2/3, Interventional, and Treatment
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.
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.
Shiraz University of Medical Sciences is the lead sponsor of 129 studies on the registry; 6 are open to participants now.
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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)
the threshold of pressure, tactile,and pain thresholds were evaluated after the application of interferential current.
Device: interferential current
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
drug delivery through interferential current.
Also known as: Dynatron 438, Enraf Nonius Comp., Netherlands
Also known as: Xylocaine 10% spray, AstraZeneca, Korea
Also known as: Dynatron 438, Enraf Nonius Comp., Netherlands
pain threshold- evaluated by increasing intensity of interferential current.
pain threshold to increasing intensity of interferential current.
Time frame: up to one week
tactile threshold- evaluated by exact perception of the lowest level of interferential current
exact perception of the lowest level of interferential current
Time frame: up to one week
pressure threshold- evaluated by Pesula
Pesula was used to evaluate tactile threshold.
Time frame: up to one week
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Shiraz University of Medical Sciences