Lidoderm Patch (Lidocaine 5%) for Tinnitus Treatment

Lidocaine Patch (Lidocaine 5%) as a Treatment for Tinnitus and Its Accompanied Symptoms

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.

Study Overview

• Status: Unknown
• Conditions: Tinnitus
• Intervention / Treatment: Device: Lidoderm patch (Lidocaine 5% patch); Procedure: blood test- serum lidocain levels; Other: Hearing tests; Other: Tegaderm patch. (neutral patch, containing no drug)

Detailed Description

The purpose of the study is to investigate whether lidoderm patch (lidocain 5% patch) cream decreases tinnitus by comparing pretrial questionnaires to post trial questionnaires.

first the investigators are going to invite tinnitus patients for the first visit.

the participants will get full explanation about the trial. in the first visit the investigators will confirm that the participants are suitable for the trial -

1. no exclusion criteria are present

2. the participant will perform 2 screening tests-

   • minimental state examination (MMSE) to evaluate patients cognitive ability to participate in this trial. performance under 24 points is an exclusion criteria
   • Beck depression test- to evaluate patient's ability to be influenced by the lidoderm patch. performance above 24 points is an exclusion criteria the participant will sign on an informed consent form and fulfill a demographic and personal details form.

the participant will undergo ear investigation to exclude ear inflammation, perform audiometry and tinnitus characteristic test to prove sensorineural hearing loss and to get details about the tinnitus characteristics. then the participant will fill 4 questionnaires that reflect the tinnitus loudness and show how much the participant does suffer from this conditions.

1. tinnitus handicap inventory.which estimates the degree that tinnitus affects patients life. it contains 25 questions . The minimum score is 0 and the maximum is 100.
2. Pittsburgh sleep quality index - A 9 questions exam that measures the quality of sleep. the range of results goes between 0-24. The higher the score- the worse is the quality of sleep.
3. visual analogue scale (VAS) for tinnitus subjective loudness evaluation (how much the patient evaluates the loudness of the tinnitus)
4. visual analogue scale (VAS) for tinnitus severity evaluation. (patient's estimation of the amount that tinnitus causes him subjective suffering) Then the investigators will perform randomization: one group will get first the lidoderm patch and later that week the tegaderm patch, the other group will get first the tegaderm patch and later on the lidoderm patch.

Later that day (in the evening), the participant will come to the department (second visit) and the ear nose and throat (ENT) doctor will attach 3 patches on his back for 12 hours (either lidoderm or tegaderm patches).

The participant will be instructed to call the chief investigator When any kind of side effect occurs (topical/ systemic).

in the next morning the participant will come back to our department. (third visit) he will-

1. fill the 4 questionnaires (tinnitus handicap inventory, pittsburgh sleeping scale, VAS severity scale and VAS loudness scale)
2. blood test for lidocaine serum level check will be carried out by a nurse that is authorized to perform blood tests.
3. removal of the patches from the patient's back. 60 hours after the third visit, the participant will attend our department (forth visit). An ENT doctor will attach 3 patches to his back (the second type of patches: participant that had already in the previous visit lidoderm patches will now have the tegaderm patches and vice versa). 12 hours later the participant comes back for his fifth visit. The same 3 steps that were performed in the third visit will be performed again (4 questionnaires, patches removal, blood test for lidocain serum determination).

The investigators hypotheses that lidoderm patches decreases tinnitus as can be estimated by the score of the 4 questionnaires that measure tinnitus aspects.

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Miki Paker, MD; Phone Number: 972-526596552; Email: chiefmiki2014@gmail.com
• Study Contact Backup: Name: Salim Mazzawi, MD; Phone Number: 972544393994; Email: Sali_ma@clalit.org.il

Study Locations

• Israel
  • Afula, Israel
    • Recruiting
    • HaEmek Medical Center
    • Contact: Miki Paker, MD; Phone Number: 972-4-6494311; Email: MIKI_PA@clalit.org.il
    • Principal Investigator: Miki Paker, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.	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.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
questionnaire results change- tinnitus handicap inventory	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	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
questionnaire results- Pittsburgh sleep quality index	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	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- visual analogue scale (VAS)	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	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 - visual analogue scale (VAS)	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	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

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel
• Investigators: Study Director: Avi Shupak, MD, "LIN" MEDICAL CENTER

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: March 3, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: tinnitus; lidocain patch
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 15-52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No