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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.
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-
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.
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-
The investigators hypotheses that lidoderm patches decreases tinnitus as can be estimated by the score of the 4 questionnaires that measure tinnitus aspects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. lidoderm patches first | Experimental | 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. |
|
| 2. tegaderm patches first | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidoderm patch (Lidocaine 5% patch) | Device | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miki Paker, MD | Contact | 972-526596552 | chiefmiki2014@gmail.com | |
| Salim Mazzawi, MD | Contact | 972544393994 | Sali_ma@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Avi Shupak, MD | "LIN" MEDICAL CENTER | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haemek Medical Center | Recruiting | Afula | Israel |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D057968 | Transdermal Patch |
| D006309 | Hearing |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D000084323 | Vestibulocochlear Physiological Phenomena |
| D010829 | Physiological Phenomena |
| D012677 | Sensation |
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|
| Tegaderm patch. (neutral patch, containing no drug) | Other | 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 |
|
| blood test- serum lidocain levels | Procedure | 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. |
|
| Hearing tests | Other | 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. |
|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |