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The Phonophoresis of Lidocaine Gel and Its Effect on Sensory Blockage

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01404468
First received: July 21, 2011
Last updated: July 27, 2011
Last verified: March 2011
History of Changes

July 21, 2011
July 27, 2011
March 2006
September 2008   (final data collection date for primary outcome measure)
Two-point discrimination,touch and maximum pain thresholds [ Time Frame: imediately after finishing the application of ultrasound (5 minutes after intervention) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01404468 on ClinicalTrials.gov Archive Site
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Not Provided
Not Provided
Not Provided
 
The Phonophoresis of Lidocaine Gel and Its Effect on Sensory Blockage
Effect of Lidocaine Phonophoresis on Sensory Blockade: Pulsed or Continuous Mode of Therapeutic Ultrasound?

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.

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.
Interventional
Phase 0
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
  • Pain
  • Impairment, Light Touch Sensation
  • 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)
  • Other: off device
    off device with Lidocaine (approximately 2 cc) was administered transdermally
    Other Name: ultrasound(Enraf,Sonopuls 434,Netherlands)
  • 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)
  • Active Comparator: pulsed
    Intervention: Device: pulsed ultrasound device with lidocaine
  • Sham Comparator: control
    Intervention: Other: off device
  • Active Comparator: continuous
    Intervention: Device: continuous ultrasound device with lidocaine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
October 2010
September 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 28 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01404468
84-7.33
Yes
rehabilitation school boss, Shiraz University of Medical Sciences
Shiraz University of Medical Sciences
Not Provided
Principal Investigator: samaneh ebrahimi, PhD student PhD student in shiraz university of medical sciences
Shiraz University of Medical Sciences
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP