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The Phonophoresis of Lidocaine Gel and Its Effect on Sensory Blockage

Primary Purpose

Pain, Impairment, Light Touch Sensation

Status
Completed
Phase
Early Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
pulsed ultrasound device with lidocaine
off device
continuous ultrasound device with lidocaine
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men and women aged 18 to 25 years

Exclusion Criteria:

  • individuals who had a disease that could affect the experiment, such as systemic disease,impairment of the sensory system(e.g.neuropathy,diabetes),cardiovascular disorders(e.g. increased blood pressure),pain due to an injury to the upper extremity,tumours,malignant and precancerous tissue,acute infection and broken skin in the area; and individuals taking medication to relieve disease symptoms were excluded

Sites / Locations

  • Samaneh Ebrahimi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Arm Label

pulsed

control

continuous

Arm Description

Outcomes

Primary Outcome Measures

Two-point discrimination,touch and maximum pain thresholds

Secondary Outcome Measures

Full Information

First Posted
July 21, 2011
Last Updated
July 27, 2011
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01404468
Brief Title
The Phonophoresis of Lidocaine Gel and Its Effect on Sensory Blockage
Official Title
Effect of Lidocaine Phonophoresis on Sensory Blockade: Pulsed or Continuous Mode of Therapeutic Ultrasound?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The optimisation of drug absorption through skin is of great value in modern therapy.Phonophoresis is the use of therapeutic ultrasound to increase percutaneous drug absorption. However,few studies have compared pulsed and continuous modes of therapeutic ultrasound.This study compared these two modes by investigating the effect of lidocaine phonophoresis on sensory blockade. Ninety-three healthy volunteers, assigned at random to one of three ultrasound groups:pulsed(ultrasound+lidocaine),continuous(ultrasound+lidocaine)and control(sham ultrasound+lidocaine). Lidocaine was administered transdermally using a transducer.Two point discrimination, touch and maximum pain thresholds were assessed before and after the intervention in each group. Pulsed ultrasound with topical lidocaine gel induced greater anaesthetic effect compared with continuous ultrasound with topical lidocaine gel and lidocaine application alone. The mechanical properties of pulsed ultrasound appear to be responsible for greater drug penetration.
Detailed Description
Lidocaine is a common local anaesthetic drug that is used topically to relieve pain,itching and burning, and also for minor surgery.However,its application via this conductive method,has been confined to surface anaesthesia because it seems that it is not possible to have a deep transmission with local drug massage, without injection or systematic administration.On the other hand,the injection of lidocaine can lead to tissue injury and pain,and its use is not advised in children. Phonophoresis is one of the common procedures for reducing these problems. Therefore, the main aim of this study was to compare the two modes of therapeutic ultrasound by assessing the effect of lidocaine gel phonophoresis on percutaneous absorption and sensory blockade.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Impairment, Light Touch Sensation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pulsed
Arm Type
Active Comparator
Arm Title
control
Arm Type
Sham Comparator
Arm Title
continuous
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
pulsed ultrasound device with lidocaine
Other Intervention Name(s)
lidocainegel(Akron,Inc.,Lake Forest,CA,USA), ultrasound(Enraf,Sonopuls 434,Netherlands)
Intervention Description
Lidocaine (approximately 2 cc) was administered transdermally using a transducer (pulsed ultrasound)
Intervention Type
Other
Intervention Name(s)
off device
Other Intervention Name(s)
ultrasound(Enraf,Sonopuls 434,Netherlands)
Intervention Description
off device with Lidocaine (approximately 2 cc) was administered transdermally
Intervention Type
Device
Intervention Name(s)
continuous ultrasound device with lidocaine
Other Intervention Name(s)
lidocaine gel(Akron, Inc.,Lake Forest,CA,USA), ultrasound (Enraf,Sonopuls 434,Netherlands)
Intervention Description
Lidocaine (approximately 2 cc) was administered transdermally using a transducer (continuous ultrasound )
Primary Outcome Measure Information:
Title
Two-point discrimination,touch and maximum pain thresholds
Time Frame
imediately after finishing the application of ultrasound (5 minutes after intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men and women aged 18 to 25 years Exclusion Criteria: individuals who had a disease that could affect the experiment, such as systemic disease,impairment of the sensory system(e.g.neuropathy,diabetes),cardiovascular disorders(e.g. increased blood pressure),pain due to an injury to the upper extremity,tumours,malignant and precancerous tissue,acute infection and broken skin in the area; and individuals taking medication to relieve disease symptoms were excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
samaneh ebrahimi, PhD student
Organizational Affiliation
PhD student in shiraz university of medical sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samaneh Ebrahimi
City
Shiraz
State/Province
Fars
ZIP/Postal Code
0098
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22265386
Citation
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.
Results Reference
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The Phonophoresis of Lidocaine Gel and Its Effect on Sensory Blockage

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