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Treating Tinnitus Using Eutectic Mixture of Local Anesthetics (EMLA) 5% Cream

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02266160
Recruitment Status : Completed
First Posted : October 16, 2014
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

Brief Summary:

The investigators like to learn whether EMLA cream 5% helps tinnitus patients. so far it is known that lidocaine I.V do helps tinnitus but until now it is not clear if topical anaesthetics (e.g EMLA cream) helps tinnitus.

The investigators are going to compare 4 days of treatment of EMLA 5% cream Versus (VS.) cetomacrogol cream (water- based lotion cream) in treating tinnitus patients.


Condition or disease Intervention/treatment Phase
Tinnitus Drug: EMLA cream 5% Other: cetomacrogol cream (lotion cream) Phase 4

Detailed Description:

The purpose of the study is to investigate whether EMLA 5% cream decreases tinnitus by comparing pretrial questionnaires to post trial questionnaires.

first we are going to invite tinnitus patients for the first visit. in the first visit we will confirm that the patients is suitable for the trial (no exclusion criteria are present) , perform ear investigation to exclude ear inflammation, perform audiometry to prove sensorineural hearing loss. then the patient will fill 3 questionnaires that reflect the tinnitus severity and show how much the patient does suffer from this conditions. the questionnaires are- beck depression index, tinnitus handicap inventory, Pittsburgh sleep quality index.

Then we will perform randomization: the investigational group will get EMLA 5% cream, the control group will get cetomacrogol cream (a lotion cream).

In the next 4 days the patients (investigational and control groups) will spread the cream for 4 hours a day in the post auricular area of the ear/ ears that suffer/s from tinnitus.

The patient will be instructed to stop the spreading and call the chief investigator When any kind of side effect occurs (topical/ systemic)after 4 days of treatment the patient will come to the clinic once again and fill the same questionnaires. 3 weeks after the beginning of the trial the patient will fill the questionnaires for the third time.

Regarding the questionnaires:

  1. Beck depression questionnaire is a 21-questions exam that checks the depression level of the patient. The minimum score is 1 the maximum is 63. The investigators hypotheses states that EMLA cream treatment decreases the Beck questionnaire score
  2. Pittsburgh sleep quality index is 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 EMLA treatment improves the results of the Pittsburgh sleep quality questionnaires.
  3. 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 EMLA cream treatment decreases the score of this questionnaire which means that EMLA cream improves patients quality of life.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: EMLA 5% as a Treatment for Tinnitus and Its Accompanied Symptoms
Study Start Date : November 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: 1

71 tinnitus patients treated with 2 gram EMLA 5% cream a day for 4 days, 4 hours a day.

we will compare the questionnaires results before and after 4 days of treatment to see whether EMLA cream changes the degree of suffer from tinnitus

Drug: EMLA cream 5%
the interventional group will spread 2 grams (2 m"l) of EMLA cream over the post auricular area. after 4 hours the patient will wash away the cream. the treatment will last 4 days.
Other Name: no other names

Sham Comparator: 2
71 tinnitus patients using cetomacrogol cream (lotion cream, does not contain any drug) for 4 days. these patients will fulfill the questionnaires as the investigational group.
Other: cetomacrogol cream (lotion cream)
lotion cream that does not contain active drug. has no contraindications




Primary Outcome Measures :
  1. questionnaire results- Beck depression questionnaire [ Time Frame: after 4 days of treatment ]
    Beck depression questionnaire: A 21- questions exam that checks the depression level of the patient. the minimum score is 1 and the maximum score is 63. The investigators hypotheses states that EMLA cream treatment decreases the Beck questionnaire score

  2. questionnaire results- Pittsburgh sleep quality index [ Time Frame: after 4 days of treatment ]
    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 EMLA treatment improves the results of Pittsburgh sleep quality index

  3. questionnaire results- tinnitus handicap inventory [ Time Frame: after 4 days of treatment ]
    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 EMLA cream treatment decreases the score of this questionnaire which means that EMLA cream improves patients quality of life


Secondary Outcome Measures :
  1. questionnaire results - Beck depression questionnaire [ Time Frame: 2 weeks after the beginning of treatment ]
    estimation of this questionnaire after 2 weeks of treatment

  2. questionnaire results- Pittsburgh sleep quality index [ Time Frame: 2 weeks after the beginning of treatment ]
    estimation of this questionnaire after 2 weeks of treatment

  3. questionnaire results- tinnitus handicap inventory [ Time Frame: 2 weeks after the beginning of treatment ]
    estimation of this questionnaire after 2 weeks of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mature (above 18 years old) patients that suffer tinnitus (unilateral/bilateral) with sensorineural hearing loss

Exclusion Criteria:

  • patients that are treated for tinnitus( psychological treatment, hearing aid)
  • drugs that affect the CNS
  • sensitivity to amide anaesthetic
  • hepatic failure
  • usage of antiarrhythmic drugs
  • severe depression any patients that develops during the trial local/ systemic symptoms such as rash, pain, itching, fever, nervousness,palpitations will be omitted from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266160


Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Study Chair: salim mazzawi, MD ENT department , "Haemek" hodpital, Afula, ISRAEL
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Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02266160    
Other Study ID Numbers: 0055-14
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HaEmek Medical Center, Israel:
tinnitus
local anaesthetic
EMLA cream 5%
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Lidocaine, Prilocaine Drug Combination
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Combined