Clinical trial NCT02750969: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tinnitus
Keywords: tinnitus
lidocain patch
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 -

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.

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

Primary outcomes:
measure: questionnaire results change- tinnitus handicap inventory
timeFrame: 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
measure: questionnaire results- Pittsburgh sleep quality index
timeFrame: 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
measure: tinnitus loudness- visual analogue scale (VAS)
timeFrame: 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
measure: tinnitus suffer - visual analogue scale (VAS)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
affiliation: "LIN" MEDICAL CENTER
name: Avi Shupak, MD
role: STUDY_DIRECTOR
References: