Clinical trial NCT02487914: Evaluation of Pressure Sense Threshold and Tactile Sensation After Lidocaine Iontophoresis Using Interferential Current
Official title: Iontophoresis Effects on Senses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Interferential Current Drug Delivery
Keywords: Drug Delivery
Iontophoresis
Lidocaine
Pressure
Tactile perception
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: pain threshold- evaluated by increasing intensity of interferential current.
timeFrame: up to one week
Secondary outcomes:
measure: tactile threshold- evaluated by exact perception of the lowest level of interferential current
timeFrame: up to one week
measure: pressure threshold- evaluated by Pesula
timeFrame: up to one week
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: School of Rehabilitation
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences
name: alireza motealleh, PhD, PT
role: STUDY_DIRECTOR
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