The Phonophoresis of Lidocaine Gel and Its Effect on Sensory Blockage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01404468
Recruitment Status : Completed
First Posted : July 28, 2011
Last Update Posted : July 28, 2011
Information provided by:
Shiraz University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Pain Impairment, Light Touch Sensation Device: pulsed ultrasound device with lidocaine Other: off device Device: continuous ultrasound device with lidocaine Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Lidocaine Phonophoresis on Sensory Blockade: Pulsed or Continuous Mode of Therapeutic Ultrasound?
Study Start Date : March 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: pulsed Device: pulsed ultrasound device with lidocaine
Lidocaine (approximately 2 cc) was administered transdermally using a transducer (pulsed ultrasound)
Other Names:
  • lidocainegel(Akron,Inc.,Lake Forest,CA,USA)
  • ultrasound(Enraf,Sonopuls 434,Netherlands)
Sham Comparator: control Other: off device
off device with Lidocaine (approximately 2 cc) was administered transdermally
Other Name: ultrasound(Enraf,Sonopuls 434,Netherlands)
Active Comparator: continuous Device: continuous ultrasound device with lidocaine
Lidocaine (approximately 2 cc) was administered transdermally using a transducer (continuous ultrasound )
Other Names:
  • lidocaine gel(Akron, Inc.,Lake Forest,CA,USA)
  • ultrasound (Enraf,Sonopuls 434,Netherlands)

Primary Outcome Measures :
  1. Two-point discrimination,touch and maximum pain thresholds [ Time Frame: imediately after finishing the application of ultrasound (5 minutes after intervention) ]

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Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01404468

Iran, Islamic Republic of
Samaneh Ebrahimi
Shiraz, Fars, Iran, Islamic Republic of, 0098
Sponsors and Collaborators
Shiraz University of Medical Sciences
Principal Investigator: samaneh ebrahimi, PhD student PhD student in shiraz university of medical sciences

Publications of Results:
Responsible Party: rehabilitation school boss, Shiraz University of Medical Sciences Identifier: NCT01404468     History of Changes
Other Study ID Numbers: 84-7.33
First Posted: July 28, 2011    Key Record Dates
Last Update Posted: July 28, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action