PainEarly Phase 1NCT01404468
The Phonophoresis of Lidocaine Gel and Its Effect on Sensory Blockage
A Early Phase 1 study testing pulsed ultrasound device with lidocaine, off device and continuous ultrasound device with lidocaine in people with Pain and Impairment, Light Touch Sensation, run by Shiraz University of Medical Sciences at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Impairment, Light Touch Sensation
- What is being tested?
- pulsed ultrasound device with lidocaine, off device and continuous ultrasound device with lidocaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteIran
- Study dates
- Mar 2006to Oct 2010
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18 to 25 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Pain, Impairment, Light Touch Sensation
- Being tested
- pulsed ultrasound device with lidocaine, off device, continuous ultrasound device with lidocaine
- Medical subject headings
- Pain, Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed ultrasound device with lidocaineDevice
Also called lidocainegel(Akron,Inc.,Lake Forest,CA,USA), ultrasound(Enraf,Sonopuls 434,Netherlands)
Lidocaine (approximately 2 cc) was administered transdermally using a transducer (pulsed ultrasound)
off deviceOther
Also called ultrasound(Enraf,Sonopuls 434,Netherlands)
off device with Lidocaine (approximately 2 cc) was administered transdermally
continuous ultrasound device with lidocaineDevice
Also called lidocaine gel(Akron, Inc.,Lake Forest,CA,USA), ultrasound (Enraf,Sonopuls 434,Netherlands)
Lidocaine (approximately 2 cc) was administered transdermally using a transducer (continuous ultrasound )
| Study group | Role | What they receive |
|---|---|---|
| pulsed | Active comparator | Not described Receives: Device: pulsed ultrasound device with lidocaine |
| control | Sham comparator | Not described Receives: Other: off device |
| continuous | Active comparator | Not described Receives: Device: continuous ultrasound device with lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-point discrimination,touch and maximum pain thresholds
Measured: imediately after finishing the application of ultrasound (5 minutes after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startMar 2006
- Primary completionSep 2008
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- samaneh ebrahimi, PhD student, Principal investigator, PhD student in shiraz university of medical sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404468
- Sponsor's protocol ID
- 84-7.33
- Status last verified
- Mar 2011
- First submitted
- 21 Jul 2011
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22265386
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lidocaine Phonophoresis on Sensory Blockade: Pulsed or Continuous Mode of Therapeutic Ultrasound?
- ClinicalTrials.gov ID
- NCT01404468
- Acronym / sponsor ID
- 84-7.33
- Conditions
- Pain, Impairment, Light Touch Sensation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pulsed | Active comparator | Device: pulsed ultrasound device with lidocaine |
| control | Sham comparator | Other: off device |
| continuous | Active comparator | Device: continuous ultrasound device with lidocaine |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men and women aged 18 to 25 years
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulsed ultrasound device with lidocaineAlso: lidocainegel(Akron,Inc.,Lake Forest,CA,USA), ultrasound(Enraf,Sonopuls 434,Netherlands)Lidocaine (approximately 2 cc) was administered transdermally using a transducer (pulsed ultrasound) | Device | pulsed |
| off deviceAlso: ultrasound(Enraf,Sonopuls 434,Netherlands)off device with Lidocaine (approximately 2 cc) was administered transdermally | Other | control |
| continuous ultrasound device with lidocaineAlso: lidocaine gel(Akron, Inc.,Lake Forest,CA,USA), ultrasound (Enraf,Sonopuls 434,Netherlands)Lidocaine (approximately 2 cc) was administered transdermally using a transducer (continuous ultrasound ) | Device | continuous |
Primary outcome
Two-point discrimination,touch and maximum pain thresholds
Time frame: imediately after finishing the application of ultrasound (5 minutes after intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
- Results publication: PubMed 22265386Ebrahimi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
samaneh ebrahimi, PhD student principal investigator
PhD student in shiraz university of medical sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing pulsed ultrasound device with lidocaine, off device and continuous ultrasound device with lidocaine in people with Pain and Impairment, Light Touch Sensation, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-point discrimination,touch and maximum pain thresholds (time frame: imediately after finishing the application of ultrasound (5 minutes after intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01404468, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2011.