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

NCT02487914 | Completed Phase 2

• 1 other identifier: 386
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Interferential Current Drug Delivery

Keywords

Drug Delivery; Iontophoresis; Lidocaine; Pressure; Tactile perception

Outcome Measures

Primary Outcomes (1)

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

  pain threshold to increasing intensity of interferential current.

  up to one week

Secondary Outcomes (2)

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

  up to one week

• pressure threshold- evaluated by Pesula

  up to one week

Study Arms (3)

lidocaine iontophoresis using interferential current

ACTIVE COMPARATOR

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)

interferential current

ACTIVE COMPARATOR

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

Device: interferential current

lidocaine

ACTIVE COMPARATOR

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

Interventions

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

drug delivery through interferential current.

Also known as: Dynatron 438, Enraf Nonius Comp., Netherlands

lidocaine iontophoresis using interferential current

Lidocaine 10% was sprayed at the identified region DRUG

Also known as: Xylocaine 10% spray, AstraZeneca, Korea

lidocaine

interferential current DEVICE

Also known as: Dynatron 438, Enraf Nonius Comp., Netherlands

interferential current

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy women with age between 18 and 25 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

School of Rehabilitation

Shiraz, Fars, 33669-71947, Iran

Location

Related Publications (23)

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MeSH Terms

Interventions

Lidocaine; Electric Stimulation Therapy

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• alireza motealleh, PhD, PT

  Shiraz University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Amin Kordi Yoosefinejad

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: July 2, 2015
• Study Start: January 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2015
• Last Updated: July 2, 2015

Record last verified: 2015-06

Locations

IR (1)