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

Primary Purpose

Tinnitus

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
EMLA cream 5%
cetomacrogol cream (lotion cream)
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, local anaesthetic, EMLA cream 5%

Eligibility Criteria

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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    1

    2

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    questionnaire results- Beck depression questionnaire
    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
    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 EMLA treatment improves the results of Pittsburgh sleep quality index
    questionnaire results- 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 EMLA cream treatment decreases the score of this questionnaire which means that EMLA cream improves patients quality of life

    Secondary Outcome Measures

    questionnaire results - Beck depression questionnaire
    estimation of this questionnaire after 2 weeks of treatment
    questionnaire results- Pittsburgh sleep quality index
    estimation of this questionnaire after 2 weeks of treatment
    questionnaire results- tinnitus handicap inventory
    estimation of this questionnaire after 2 weeks of treatment

    Full Information

    First Posted
    September 22, 2014
    Last Updated
    February 27, 2018
    Sponsor
    HaEmek Medical Center, Israel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02266160
    Brief Title
    Treating Tinnitus Using Eutectic Mixture of Local Anesthetics (EMLA) 5% Cream
    Official Title
    EMLA 5% as a Treatment for Tinnitus and Its Accompanied Symptoms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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: 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 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tinnitus
    Keywords
    tinnitus, local anaesthetic, EMLA cream 5%

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    142 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    2
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    EMLA cream 5%
    Other Intervention Name(s)
    no other names
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    cetomacrogol cream (lotion cream)
    Intervention Description
    lotion cream that does not contain active drug. has no contraindications
    Primary Outcome Measure Information:
    Title
    questionnaire results- Beck depression questionnaire
    Description
    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
    Time Frame
    after 4 days of treatment
    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 EMLA treatment improves the results of Pittsburgh sleep quality index
    Time Frame
    after 4 days of treatment
    Title
    questionnaire results- 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 EMLA cream treatment decreases the score of this questionnaire which means that EMLA cream improves patients quality of life
    Time Frame
    after 4 days of treatment
    Secondary Outcome Measure Information:
    Title
    questionnaire results - Beck depression questionnaire
    Description
    estimation of this questionnaire after 2 weeks of treatment
    Time Frame
    2 weeks after the beginning of treatment
    Title
    questionnaire results- Pittsburgh sleep quality index
    Description
    estimation of this questionnaire after 2 weeks of treatment
    Time Frame
    2 weeks after the beginning of treatment
    Title
    questionnaire results- tinnitus handicap inventory
    Description
    estimation of this questionnaire after 2 weeks of treatment
    Time Frame
    2 weeks after the beginning of treatment

    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 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    salim mazzawi, MD
    Organizational Affiliation
    ENT department , "Haemek" hodpital, Afula, ISRAEL
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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