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
About this trial
This is an interventional treatment trial for Tinnitus focused on measuring tinnitus, local anaesthetic, EMLA cream 5%
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
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
NCT ID
NCT02266160
First Posted
September 22, 2014
Last Updated
February 27, 2018
Sponsor
HaEmek Medical Center, Israel
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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Treating Tinnitus Using Eutectic Mixture of Local Anesthetics (EMLA) 5% Cream
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