EMLA 5% as a Treatment for Tinnitus and Its Accompanied Symptoms
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 142
- 主要终点
- questionnaire results- Beck depression questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mature (above 18 years old) patients that suffer tinnitus (unilateral/bilateral) with sensorineural hearing loss
排除标准
- •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
研究组 & 干预措施
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.
干预措施: cetomacrogol cream (lotion cream) (Other)
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
干预措施: EMLA cream 5% (Drug)
结局指标
主要结局
questionnaire results- Beck depression questionnaire
时间窗: 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
questionnaire results- Pittsburgh sleep quality index
时间窗: 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
questionnaire results- tinnitus handicap inventory
时间窗: 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
次要结局
- questionnaire results - Beck depression questionnaire(2 weeks after the beginning of treatment)
- questionnaire results- Pittsburgh sleep quality index(2 weeks after the beginning of treatment)
- questionnaire results- tinnitus handicap inventory(2 weeks after the beginning of treatment)