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Completed

NCT Number: NCT02487914

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

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.

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Key information

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

School of Rehabilitation

Shiraz, Fars, 33669-71947, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iontophoresis of Lidocaine 10% with interferential current (Dynatron 438)

Device

drug delivery through interferential current.

Other names: Dynatron 438, Enraf Nonius Comp., Netherlands

Lidocaine 10% was sprayed at the identified region

Drug

Other names: Xylocaine 10% spray, AstraZeneca, Korea

Interferential Current

Device

Other names: Dynatron 438, Enraf Nonius Comp., Netherlands

Primary outcomes

  1. pain threshold- evaluated by increasing intensity of interferential current.

    Time frame: up to one week

    pain threshold to increasing intensity of interferential current.

Secondary outcomes

  1. tactile threshold- evaluated by exact perception of the lowest level of interferential current

    Time frame: up to one week

    exact perception of the lowest level of interferential current

  2. pressure threshold- evaluated by Pesula

    Time frame: up to one week

    Pesula was used to evaluate tactile threshold.

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

Iontophoresis Effects on Senses

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jul 2, 2015
Registry last updated
Jul 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.