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Lidoderm Patch (Lidocaine 5%) for Tinnitus Treatment

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ClinicalTrials.gov Identifier: NCT02750969
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

Brief Summary:

The investigators like to learn whether Lidoderm patch (lidocaine 5%) helps tinnitus patients.

so far it is known that lidocaine I.V do helps tinnitus but until now it is not clear if other means of drug delivery (e.g lidocaine patch) help tinnitus.

The investigators are going to compare 1 day of treatment with lidoderm patch cream Versus (VS.) tegaderm patch (containing no drug) in treating tinnitus patients.


Condition or disease Intervention/treatment Phase
Tinnitus Device: Lidoderm patch (Lidocaine 5% patch) Other: Tegaderm patch. (neutral patch, containing no drug) Procedure: blood test- serum lidocain levels Other: Hearing tests Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lidocaine Patch (Lidocaine 5%) as a Treatment for Tinnitus and Its Accompanied Symptoms
Actual Study Start Date : April 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: 1. lidoderm patches first

29 tinnitus patients treated first with 3 patches of lidoderm for 1 day, for 12 consecutive hours. 60 hours after removal of the patches the patients will have 3 neutral patches (containing no drug) attach to their back for 12 hours.

after the removal of each kind of patch the patient will fill 4 types of questionnaires that assess his amount of tinnitus we will compare the questionnaires results before and after the application of those patches.

Device: Lidoderm patch (Lidocaine 5% patch)

The investigator will attach the patches on the patient's back for 12 consecutive hours.

tinnitus questionnaires will be fulfilled by the patient before and after the patches usage . blood test for serum lidocaine level will be measured after the usage of this patch

Other Name: no other names

Procedure: blood test- serum lidocain levels

each participant will undergo blood test. the participant's group that start the trial with the lidoderm patch and later will use the tegaderm patch will have 2 blood tests for werum lidocain level test. the group taht start the trial with the tegaderm patch and later the lidoderm patch will have only one blood test measuring lidocaine serum level.

the tubes containing the serum will be shipped abroad via an international medical cargo company for lidocaine levels tests.


Other: Hearing tests
each participant that have not done hearing test in the last 1 year previous to the trial will have one in the first day of the trial.

Experimental: 2. tegaderm patches first

29 tinnitus patients treated first with 3 patches of tegaderm (neutral patch containing no drug) for 1 day, for 12 consecutive hours. 60 hours after removal of the patches the patients will have 3 lidoderm patches attach to their back for 12 hours.

after the removal of each kind of patch the patient will fill 4 types of questionnaires that assess his amount of tinnitus we will compare the questionnaires results before and after the application of those patches.

Other: Tegaderm patch. (neutral patch, containing no drug)

The investigator will attach the patches on the patient's back for 12 consecutive hours.

tinnitus questionnaires will be fulfilled by the patient before and after the patches usage . blood test for serum lidocaine level will be measured after the usage of this patch


Procedure: blood test- serum lidocain levels

each participant will undergo blood test. the participant's group that start the trial with the lidoderm patch and later will use the tegaderm patch will have 2 blood tests for werum lidocain level test. the group taht start the trial with the tegaderm patch and later the lidoderm patch will have only one blood test measuring lidocaine serum level.

the tubes containing the serum will be shipped abroad via an international medical cargo company for lidocaine levels tests.


Other: Hearing tests
each participant that have not done hearing test in the last 1 year previous to the trial will have one in the first day of the trial.




Primary Outcome Measures :
  1. questionnaire results change- tinnitus handicap inventory [ Time Frame: 1 week: the time between the questionnaire results at the beginning andcompared to the results after using the tegaderm patch and the results after using the lidoderm patch ]
    tinnitus handicap inventory: estimates the degree that tinnitus affects patients life. It contains 25 questions. The minimum score is 0 and the maximum is 100. The investigators hypotheses that lidoderm patch treatment decreases the score of this questionnaire which means that lidoderm patch improves patients quality of life

  2. questionnaire results- Pittsburgh sleep quality index [ Time Frame: 1 week: the time between the questionnaire results at the beginning andcompared to the results after using the tegaderm patch and the results after using the lidoderm patch ]
    Pittsburgh sleep quality index : A 9 questions exam that measure the quality of sleep. The range of results goes between 0-24. The higher the score - the worse is the quality of sleep. The investigators hypotheses states that lidoderm treatment improves the results of Pittsburgh sleep quality index

  3. tinnitus loudness- visual analogue scale (VAS) [ Time Frame: 1 week: the time between the questionnaire results at the beginning andcompared to the results after using the tegaderm patch and the results after using the lidoderm patch ]
    Tinnitus loudness scale: A range of 1-10 scale. the patient choose which number reflects the loudness of the subjective tinnitus which the patients suffer from. the higher the number- the louder the tinnitus

  4. tinnitus suffer - visual analogue scale (VAS) [ Time Frame: 1 week: the time between the questionnaire results at the beginning andcompared to the results after using the tegaderm patch and the results after using the lidoderm patch ]
    Tinnitus suffer scale: A range of 1-10 scale. the patient choose which number reflects the best the degree in which the tinnitus causes the patient to suffer. the higher the score- the worse is the tinnitus



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mature (above 18 years old) patients that suffer at least 1 year of tinnitus (unilateral/bilateral

Exclusion Criteria:

  • Intermittent/ fluctuative type of tinnitus
  • patients that are treated for tinnitus( psychological treatment, hearing aid, drugs, sound generator) or were treated in the last month
  • sensitivity to amide anaesthetic
  • known hepatic failure
  • usage of antiarrhythmic drugs of type 1
  • history of seizures
  • pregnancy/ lactating
  • dermatologic problems in the back
  • any patients that develops during the trial local/ systemic symptoms such as rash, pain, itching, fever, nervousness,palpitations will be omitted from the study
  • beck depression score of >21
  • MMSE test <24

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 ClinicalTrials.gov identifier (NCT number): NCT02750969


Contacts
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Contact: Miki Paker, MD 972-526596552 chiefmiki2014@gmail.com
Contact: Salim Mazzawi, MD 972544393994 Sali_ma@clalit.org.il

Locations
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Israel
Haemek Medical Center Recruiting
Afula, Israel
Contact: Miki Paker, MD    972-4-6494311    MIKI_PA@clalit.org.il   
Principal Investigator: Miki Paker, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Study Director: Avi Shupak, MD "LIN" MEDICAL CENTER

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Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02750969     History of Changes
Other Study ID Numbers: 15-52
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by HaEmek Medical Center, Israel:
tinnitus
lidocain patch

Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
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