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

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ClinicalTrials.gov Identifier: NCT02487914
Recruitment Status : Completed
First Posted : July 2, 2015
Last Update Posted : July 2, 2015
Sponsor:
Information provided by (Responsible Party):
Alireza Motealleh, 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.

Condition or disease Intervention/treatment Phase
Interferential Current Drug Delivery Device: iontophoresis of Lidocaine 10% with interferential current (Dynatron 438) Drug: Lidocaine 10% was sprayed at the identified region Device: interferential current Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Iontophoresis Effects on Senses
Study Start Date : January 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Xylocaine 10% spray, AstraZeneca, Korea




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487914


Locations
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Iran, Islamic Republic of
School of Rehabilitation
Shiraz, Fars, Iran, Islamic Republic of, 33669-71947
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
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Study Director: alireza motealleh, PhD, PT Shiraz University of Medical Sciences

Publications of Results:
Other Publications:
Jadoul A, Doucet J, Durand D, Preat V. Modifications induced on stratum corneum structure after in vitro iontophoresis; ATR-FTIR and X-ray scattering studies. J. Controlled Release 42: 165-173,1996.
Panzade P, Puranik P. Iontophoresis: A Functional Approach for Enhancement of Transdermal Drug Delivery. Asian Journal of Biomedical and Pharmaceutical Sciences 2(11): 1-8, 2012.
Kandell ER, Schwartz JH, Jessell TM. Principles of neural science 2000. 4th edition.

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Responsible Party: Alireza Motealleh, Dr. Amin Kordi Yoosefinejad, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02487914    
Other Study ID Numbers: 386
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: July 2, 2015
Last Verified: June 2015
Keywords provided by Alireza Motealleh, Shiraz University of Medical Sciences:
Drug Delivery
Iontophoresis
Lidocaine
Pressure
Tactile perception
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action