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Lidoderm Patch (Lidocaine 5%) for Tinnitus Treatment

H

HaEmek Medical Center, Israel

Status and phase

Unknown
Phase 4

Conditions

Tinnitus

Treatments

Procedure: blood test- serum lidocain levels
Other: Tegaderm patch. (neutral patch, containing no drug)
Other: Hearing tests
Device: Lidoderm patch (Lidocaine 5% patch)

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

58 participants in 2 patient groups

1. lidoderm patches first
Experimental group
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.
Treatment:
Device: Lidoderm patch (Lidocaine 5% patch)
Procedure: blood test- serum lidocain levels
Other: Hearing tests
2. tegaderm patches first
Experimental group
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.
Treatment:
Procedure: blood test- serum lidocain levels
Other: Tegaderm patch. (neutral patch, containing no drug)
Other: Hearing tests

Trial contacts and locations

1

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Central trial contact

Miki Paker, MD; Salim Mazzawi, MD

Data sourced from clinicaltrials.gov

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