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

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Interferential Current Drug Delivery

Treatments: Device: interferential current; Device: iontophoresis of Lidocaine 10% with interferential current (Dynatron 438); Drug: Lidocaine 10% was sprayed at the identified region

Study type: Interventional

Funder types: Other

Identifiers

NCT02487914

386

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

30 participants in 3 patient groups

lidocaine iontophoresis using interferential current

Active Comparator group

Description:

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

Treatment:

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

interferential current

Active Comparator group

Description:

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

Treatment:

Device: interferential current

lidocaine

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine 10% was sprayed at the identified region