NCT01404468

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P75+ for early_phase_1 pain

Timeline
Completed

Started Mar 2006

Longer than P75 for early_phase_1 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2011

Completed
Last Updated

July 28, 2011

Status Verified

March 1, 2011

Enrollment Period

2.5 years

First QC Date

July 21, 2011

Last Update Submit

July 27, 2011

Conditions

PainImpairment, Light Touch Sensation

Outcome Measures

Primary Outcomes (1)

  • Two-point discrimination,touch and maximum pain thresholds

    imediately after finishing the application of ultrasound (5 minutes after intervention)

Study Arms (3)

pulsed

ACTIVE COMPARATOR
Device: pulsed ultrasound device with lidocaine

control

SHAM COMPARATOR
Other: off device

continuous

ACTIVE COMPARATOR
Device: continuous ultrasound device with lidocaine

Interventions

pulsed ultrasound device with lidocaineDEVICE

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

Also known as: lidocainegel(Akron,Inc.,Lake Forest,CA,USA), ultrasound(Enraf,Sonopuls 434,Netherlands)
pulsed
off deviceOTHER

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

Also known as: ultrasound(Enraf,Sonopuls 434,Netherlands)
control
continuous ultrasound device with lidocaineDEVICE

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

Also known as: lidocaine gel(Akron, Inc.,Lake Forest,CA,USA), ultrasound (Enraf,Sonopuls 434,Netherlands)
continuous

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women aged 18 to 25 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samaneh Ebrahimi

Shiraz, Fars, 0098, Iran

Location

Related Publications (1)

  • 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.

    PMID: 22265386RESULT

MeSH Terms

Conditions

PainSomatosensory Disorders

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSensation DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • samaneh ebrahimi, PhD student

    PhD student in shiraz university of medical sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2011

First Posted

July 28, 2011

Study Start

March 1, 2006

Primary Completion

September 1, 2008

Study Completion

October 1, 2010

Last Updated

July 28, 2011

Record last verified: 2011-03

Locations

IR(1)