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Interferential Current Drug DeliveryPhase 2/3NCT02487914

Evaluation of Pressure Sense Threshold and Tactile Sensation After Lidocaine Iontophoresis Using Interferential Current

A Phase 2/3 study testing iontophoresis of Lidocaine 10% with interferential current (Dynatron 438), Lidocaine 10% was sprayed at the identified region and interferential current in people with Interferential Current Drug Delivery, run by Shiraz University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Drug delivery is conducted through various methods such as injection, phonophoresis, and iontophoresis. Iontophoresis is defined as the noninvasive delivery of active ions through epidermis using direct current. The direct current has some disadvantages such as skin burning and limited time of application. Read more about this study

Who is it for?
Ages 18 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for
Interferential Current Drug Delivery
What is being tested?
iontophoresis of Lidocaine 10% with interferential current (Dynatron 438), Lidocaine 10% was sprayed at the identified region and interferential current
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIran
Study dates
Jan 2013to Mar 2015
Phase
Phase 2/3
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 25 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • healthy women with age between 18 and 25 years old

Who cannot join

  • Systemic disorders,
  • neuro-muscular diseases such as diabetes and all forms of neuropathies,
  • and use of narcoleptic drugs which may contaminate the results.
  • Also, none of the participants were on their menstrual cycle.

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • School of Rehabilitation

    Shiraz, Fars, 33669-71947

Other trials in Iran

About this study

Official title: Iontophoresis Effects on Senses

Drug delivery is conducted through various methods such as injection, phonophoresis, and iontophoresis. Iontophoresis is defined as the noninvasive delivery of active ions through epidermis using direct current. The direct current has some disadvantages such as skin burning and limited time of application. Interferential current is a kind of alternating currents without limitations of direct current; so the purpose of this study was to investigate and compare the effects of Lidocaine, interferential current and Lidocaine iontophoresis using interferential current.

Read the detailed description

Pressure, tactile, and pain thresholds were evaluated before and after the application of Lidocaine, interferential current and Lidocaine iontophoresis using interferential current. Pressure threshold was investigated with a Pesula. Pesula is a pen-like scaled mechanical device that measures the skin pressure threshold. Pesula was pressed to the skin and pressure threshold was measured in mm. Pain and tactile thresholds were investigated using an electrical stimulator.The intensity was gradually increased to the extent that the participant reported a tingling sensation. The displayed intensity was considered as the tactile sense threshold. Then, the intensity was increased to the extent to be intolerable for the participant and this intensity was considered as the maximum pain threshold. The thresholds were recorded in milliampere.

Lidocaine iontophoresis using interferential current can increase perception threshold of pain, and pressure sense more significantly in comparison to the application of Lidocaine and interferential current alone.

Being tested
iontophoresis of Lidocaine 10% with interferential current (Dynatron 438), Lidocaine 10% was sprayed at the identified region, interferential current
Keywords
Drug Delivery, Iontophoresis, Lidocaine, Pressure, Tactile perception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iontophoresis of Lidocaine 10% with interferential current (Dynatron 438)Device

    Also called Dynatron 438, Enraf Nonius Comp., Netherlands

    drug delivery through interferential current.

  • Lidocaine 10% was sprayed at the identified regionDrug

    Also called Xylocaine 10% spray, AstraZeneca, Korea

  • interferential currentDevice

    Also called Dynatron 438, Enraf Nonius Comp., Netherlands

Study groups in NCT02487914
Study groupRoleWhat they receive
lidocaine iontophoresis using interferential currentActive comparatorthe threshold of pressure, tactile,and pain thresholds were evaluated after the iontophoresis of Lidocaine using interferential current.
Receives: Device: iontophoresis of Lidocaine 10% with interferential current (Dynatron 438)
interferential currentActive comparatorthe threshold of pressure, tactile,and pain thresholds were evaluated after the application of interferential current.
Receives: Device: interferential current
lidocaineActive comparatorthe threshold of pressure, tactile,and pain thresholds were evaluated after the application of topical Lidocaine.
Receives: Drug: Lidocaine 10% was sprayed at the identified region

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain threshold- evaluated by increasing intensity of interferential current.

    pain threshold to increasing intensity of interferential current.

    Measured: up to one week

Secondary outcomes (2)

  1. tactile threshold- evaluated by exact perception of the lowest level of interferential current

    exact perception of the lowest level of interferential current

    Measured: up to one week

  2. pressure threshold- evaluated by Pesula

    Pesula was used to evaluate tactile threshold.

    Measured: up to one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2015 (estimated)
  2. Study startJan 2013
  3. Primary completionMar 2014
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02487914
Sponsor's protocol ID
386
Status last verified
Jun 2015
First submitted
15 Jun 2015
Last updated
2 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • Baskurt F, Ozcan A, Algun C. Comparison of effects of phonophoresis and iontophoresis of naproxen in the treatment of lateral epicondylitis. Clin Rehabil. 2003 Feb;17(1):96-100. doi: 10.1191/0269215503cr588oa.

    PubMed 12617384

  • 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

  • Gokoglu F, Findikoglu G, Yorgancoglu ZR, Okumus M, Ceceli E, Kocaoglu S. Evaluation of iontophoresis and local corticosteroid injection in the treatment of carpal tunnel syndrome. Am J Phys Med Rehabil. 2005 Feb;84(2):92-6. doi: 10.1097/01.phm.0000151942.49031.dd.

    PubMed 15668556

  • Pal B, Morris J. Perceived risks of joint infection following intra-articular corticosteroid injections: a survey of rheumatologists. Clin Rheumatol. 1999;18(3):264-5. doi: 10.1007/s100670050098.

    PubMed 11206357

  • Jadoul A, Bouwstra J, Preat V V. Effects of iontophoresis and electroporation on the stratum corneum. Review of the biophysical studies. Adv Drug Deliv Rev. 1999 Jan 4;35(1):89-105. doi: 10.1016/s0169-409x(98)00065-9.

    PubMed 10837691

  • Jadoul A, Doucet J, Durand D, Preat V. Modifications induced on stratum corneum structure after in vitro iontophoresis; ATR-FTIR and X-ray scattering studies. J. Controlled Release 42: 165-173,1996.

  • Thysman S, Van Neste D, Preat V. Noninvasive investigation of human skin after in vivo iontophoresis. Skin Pharmacol. 1995;8(5):229-36. doi: 10.1159/000211352.

    PubMed 8527154

  • Costello CT, Jeske AH. Iontophoresis: applications in transdermal medication delivery. Phys Ther. 1995 Jun;75(6):554-63. doi: 10.1093/ptj/75.6.554.

    PubMed 7770500

  • Singh P, Maibach HI. Iontophoresis in drug delivery: basic principles and applications. Crit Rev Ther Drug Carrier Syst. 1994;11(2-3):161-213.

    PubMed 7600587

  • Panzade P, Puranik P. Iontophoresis: A Functional Approach for Enhancement of Transdermal Drug Delivery. Asian Journal of Biomedical and Pharmaceutical Sciences 2(11): 1-8, 2012.

  • Banga AK, Chien YW. Hydrogel-based iontotherapeutic delivery devices for transdermal delivery of peptide/protein drugs. Pharm Res. 1993 May;10(5):697-702. doi: 10.1023/a:1018955631835.

    PubMed 8321834

  • Gupta SK, Bernstein KJ, Noorduin H, Van Peer A, Sathyan G, Haak R. Fentanyl delivery from an electrotransport system: delivery is a function of total current, not duration of current. J Clin Pharmacol. 1998 Oct;38(10):951-8. doi: 10.1002/j.1552-4604.1998.tb04392.x.

    PubMed 9807977

  • Lvovich VF, Matthews E, Riga AT, Kaza L. AC electrokinetic platform for iontophoretic transdermal drug delivery. J Control Release. 2010 Jul 14;145(2):134-40. doi: 10.1016/j.jconrel.2010.04.015. Epub 2010 Apr 24.

    PubMed 20420867

  • Reinauer S, Neusser A, Schauf G, Holzle E. Iontophoresis with alternating current and direct current offset (AC/DC iontophoresis): a new approach for the treatment of hyperhidrosis. Br J Dermatol. 1993 Aug;129(2):166-9. doi: 10.1111/j.1365-2133.1993.tb03521.x.

    PubMed 7654577

  • Ganne JM. Interferential therapy. Aust J Physiother. 1976 Sep;22(3):101-10. doi: 10.1016/S0004-9514(14)61005-9.

    PubMed 25026222

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing iontophoresis of Lidocaine 10% with interferential current (Dynatron 438), Lidocaine 10% was sprayed at the identified region and interferential current in people with Interferential Current Drug Delivery, 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 4 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 2 Jul 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

pain threshold- evaluated by increasing intensity of interferential current. (time frame: up to one week). 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 NCT02487914, which also lists 23 linked publications.

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 2 Jul 2015.

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