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

Iontophoresis Effects on Senses

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02487914
Enrollment
30
Registered
2015-07-02
Start date
2013-01-31
Completion date
2015-03-31
Last updated
2015-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interferential Current Drug Delivery

Keywords

Drug Delivery, Iontophoresis, Lidocaine, Pressure, Tactile perception

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.

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.

Interventions

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

drug delivery through interferential current.

DRUGLidocaine 10% was sprayed at the identified region

Sponsors

Shiraz University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
pain threshold- evaluated by increasing intensity of interferential current.up to one weekpain threshold to increasing intensity of interferential current.

Secondary

MeasureTime frameDescription
tactile threshold- evaluated by exact perception of the lowest level of interferential currentup to one weekexact perception of the lowest level of interferential current
pressure threshold- evaluated by Pesulaup to one weekPesula was used to evaluate tactile threshold.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026