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Lidoderm Patch (Lidocaine 5%) for Tinnitus Treatment

Primary Purpose

Tinnitus

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Lidoderm patch (Lidocaine 5% patch)
Tegaderm patch. (neutral patch, containing no drug)
blood test- serum lidocain levels
Hearing tests
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring tinnitus, lidocain patch

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haemek Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1. lidoderm patches first

2. tegaderm patches first

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
March 3, 2016
Last Updated
February 27, 2018
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT02750969
Brief Title
Lidoderm Patch (Lidocaine 5%) for Tinnitus Treatment
Official Title
Lidocaine Patch (Lidocaine 5%) as a Treatment for Tinnitus and Its Accompanied Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (Actual)
Primary Completion Date
February 2019 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 - no exclusion criteria are present 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. 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. 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. visual analogue scale (VAS) for tinnitus subjective loudness evaluation (how much the patient evaluates the loudness of the tinnitus) 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- fill the 4 questionnaires (tinnitus handicap inventory, pittsburgh sleeping scale, VAS severity scale and VAS loudness scale) blood test for lidocaine serum level check will be carried out by a nurse that is authorized to perform blood tests. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
tinnitus, lidocain patch

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1. lidoderm patches first
Arm Type
Experimental
Arm Description
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.
Arm Title
2. tegaderm patches first
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Lidoderm patch (Lidocaine 5% patch)
Other Intervention Name(s)
no other names
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Tegaderm patch. (neutral patch, containing no drug)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
blood test- serum lidocain levels
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Hearing tests
Intervention Description
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 Measure Information:
Title
questionnaire results change- tinnitus handicap inventory
Description
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
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
Title
questionnaire results- Pittsburgh sleep quality index
Description
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
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
Title
tinnitus loudness- visual analogue scale (VAS)
Description
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
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
Title
tinnitus suffer - visual analogue scale (VAS)
Description
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miki Paker, MD
Phone
972-526596552
Email
chiefmiki2014@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Salim Mazzawi, MD
Phone
972544393994
Email
Sali_ma@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avi Shupak, MD
Organizational Affiliation
"LIN" MEDICAL CENTER
Official's Role
Study Director
Facility Information:
Facility Name
Haemek Medical Center
City
Afula
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miki Paker, MD
Phone
972-4-6494311
Email
MIKI_PA@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Miki Paker, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Lidoderm Patch (Lidocaine 5%) for Tinnitus Treatment

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