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The Phonophoresis of Lidocaine Gel and Its Effect on Sensory Blockage

NCT ID: NCT01404468

Last Updated: 2011-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2010-10-31

Brief Summary

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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

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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.

Conditions

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Pain Impairment, Light Touch Sensation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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pulsed

Group Type ACTIVE_COMPARATOR

pulsed ultrasound device with lidocaine

Intervention Type DEVICE

Lidocaine (approximately 2 cc) was administered transdermally using a transducer (pulsed ultrasound)

control

Group Type SHAM_COMPARATOR

off device

Intervention Type OTHER

off device with Lidocaine (approximately 2 cc) was administered transdermally

continuous

Group Type ACTIVE_COMPARATOR

continuous ultrasound device with lidocaine

Intervention Type DEVICE

Lidocaine (approximately 2 cc) was administered transdermally using a transducer (continuous ultrasound )

Interventions

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pulsed ultrasound device with lidocaine

Lidocaine (approximately 2 cc) was administered transdermally using a transducer (pulsed ultrasound)

Intervention Type DEVICE

off device

off device with Lidocaine (approximately 2 cc) was administered transdermally

Intervention Type OTHER

continuous ultrasound device with lidocaine

Lidocaine (approximately 2 cc) was administered transdermally using a transducer (continuous ultrasound )

Intervention Type DEVICE

Other Intervention Names

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lidocainegel(Akron,Inc.,Lake Forest,CA,USA) ultrasound(Enraf,Sonopuls 434,Netherlands) ultrasound(Enraf,Sonopuls 434,Netherlands) lidocaine gel(Akron, Inc.,Lake Forest,CA,USA) ultrasound (Enraf,Sonopuls 434,Netherlands)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Shiraz University of Medical Sciences

Principal Investigators

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samaneh ebrahimi, PhD student

Role: PRINCIPAL_INVESTIGATOR

PhD student in shiraz university of medical sciences

Locations

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Samaneh Ebrahimi

Shiraz, Fars, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type RESULT
PMID: 22265386 (View on PubMed)

Other Identifiers

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84-7.33

Identifier Type: -

Identifier Source: org_study_id