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

July 1, 2015 updated by: Alireza Motealleh, Shiraz University of Medical Sciences

Iontophoresis Effects on Senses

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: lidocaine iontophoresis using interferential current
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)
drug delivery through interferential current.
Other Names:
  • Dynatron 438, Enraf Nonius Comp., Netherlands
Active Comparator: interferential current
the threshold of pressure, tactile,and pain thresholds were evaluated after the application of interferential current.
Device: interferential current
Other Names:
  • Dynatron 438, Enraf Nonius Comp., Netherlands
Active Comparator: lidocaine
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
Other Names:
  • Xylocaine 10% spray, AstraZeneca, Korea

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Investigators

  • Study Director: alireza motealleh, PhD, PT, Shiraz University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (Estimate)

July 2, 2015

Study Record Updates

Last Update Posted (Estimate)

July 2, 2015

Last Update Submitted That Met QC Criteria

July 1, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 386

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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