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

NCT ID: NCT02487914

Last Updated: 2015-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-03-31

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.

Conditions

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Interferential Current Drug Delivery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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lidocaine iontophoresis using interferential current

the threshold of pressure, tactile,and pain thresholds were evaluated after the iontophoresis of Lidocaine using interferential current.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

drug delivery through interferential current.

interferential current

the threshold of pressure, tactile,and pain thresholds were evaluated after the application of interferential current.

Group Type ACTIVE_COMPARATOR

interferential current

Intervention Type DEVICE

lidocaine

the threshold of pressure, tactile,and pain thresholds were evaluated after the application of topical Lidocaine.

Group Type ACTIVE_COMPARATOR

Lidocaine 10% was sprayed at the identified region

Intervention Type DRUG

Interventions

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

drug delivery through interferential current.

Intervention Type DEVICE

Lidocaine 10% was sprayed at the identified region

Intervention Type DRUG

interferential current

Intervention Type DEVICE

Other Intervention Names

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Dynatron 438, Enraf Nonius Comp., Netherlands Xylocaine 10% spray, AstraZeneca, Korea Dynatron 438, Enraf Nonius Comp., Netherlands

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Alireza Motealleh

Dr. Amin Kordi Yoosefinejad

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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alireza motealleh, PhD, PT

Role: STUDY_DIRECTOR

Shiraz University of Medical Sciences

Locations

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School of Rehabilitation

Shiraz, Fars, Iran

Site Status

Countries

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Iran

References

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Reference Type BACKGROUND
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Ebrahimi S, Abbasnia K, Motealleh A, Kooroshfard N, Kamali F, Ghaffarinezhad F. Effect of lidocaine phonophoresis on sensory blockade: pulsed or continuous mode of therapeutic ultrasound? Physiotherapy. 2012 Mar;98(1):57-63. doi: 10.1016/j.physio.2011.01.009.

Reference Type BACKGROUND
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Gokoglu F, Findikoglu G, Yorgancoglu ZR, Okumus M, Ceceli E, Kocaoglu S. Evaluation of iontophoresis and local corticosteroid injection in the treatment of carpal tunnel syndrome. Am J Phys Med Rehabil. 2005 Feb;84(2):92-6. doi: 10.1097/01.phm.0000151942.49031.dd.

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Jadoul A, Bouwstra J, Preat V V. Effects of iontophoresis and electroporation on the stratum corneum. Review of the biophysical studies. Adv Drug Deliv Rev. 1999 Jan 4;35(1):89-105. doi: 10.1016/s0169-409x(98)00065-9.

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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.

Reference Type BACKGROUND

Thysman S, Van Neste D, Preat V. Noninvasive investigation of human skin after in vivo iontophoresis. Skin Pharmacol. 1995;8(5):229-36. doi: 10.1159/000211352.

Reference Type BACKGROUND
PMID: 8527154 (View on PubMed)

Costello CT, Jeske AH. Iontophoresis: applications in transdermal medication delivery. Phys Ther. 1995 Jun;75(6):554-63. doi: 10.1093/ptj/75.6.554.

Reference Type BACKGROUND
PMID: 7770500 (View on PubMed)

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Reference Type BACKGROUND
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Reference Type BACKGROUND

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Bhatia G, Banga AK. Effect of modulated alternating and direct current iontophoresis on transdermal delivery of lidocaine hydrochloride. Biomed Res Int. 2014;2014:537941. doi: 10.1155/2014/537941. Epub 2014 May 15.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND

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Reference Type RESULT
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Other Identifiers

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386

Identifier Type: -

Identifier Source: org_study_id

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