The Phonophoresis of Lidocaine Gel and Its Effect on Sensory Blockage

Pain Clinical Trial

Official title:

Effect of Lidocaine Phonophoresis on Sensory Blockade: Pulsed or Continuous Mode of Therapeutic Ultrasound?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404468
• Other study ID #: 84-7.33
• Status: Completed
• Phase: Phase 0
• First received: July 21, 2011
• Last updated: July 27, 2011
• Start date: March 2006
• Est. completion date: October 2010

Study information

• Verified date: March 2011
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 2010
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 28 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Impairment, Light Touch Sensation
• Pain
• Somatosensory Disorders

Intervention

Device:
• pulsed ultrasound device with lidocaine
Lidocaine (approximately 2 cc) was administered transdermally using a transducer (pulsed ultrasound)

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

Device:
• continuous ultrasound device with lidocaine
Lidocaine (approximately 2 cc) was administered transdermally using a transducer (continuous ultrasound )

Locations

Country	Name	City	State
Iran, Islamic Republic of	Samaneh Ebrahimi	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two-point discrimination,touch and maximum pain thresholds		imediately after finishing the application of ultrasound (5 minutes after intervention)	No