Lidocaine Patch (Lidocaine 5%) as a Treatment for Tinnitus and Its Accompanied Symptoms
试验速览
- 阶段
- 4 期
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- questionnaire results- Pittsburgh sleep quality index
研究概览
简要总结
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.
详细描述
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 -
- no exclusion criteria are present
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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 at least 1 year of tinnitus (unilateral/bilateral
排除标准
- •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
研究组 & 干预措施
1. lidoderm patches first
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.
干预措施: Lidoderm patch (Lidocaine 5% patch) (Device)
1. lidoderm patches first
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.
干预措施: blood test- serum lidocain levels (Procedure)
1. lidoderm patches first
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.
干预措施: Hearing tests (Other)
2. tegaderm patches first
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.
干预措施: Tegaderm patch. (neutral patch, containing no drug) (Other)
2. tegaderm patches first
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.
干预措施: blood test- serum lidocain levels (Procedure)
2. tegaderm patches first
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.
干预措施: Hearing tests (Other)
结局指标
主要结局
questionnaire results- Pittsburgh sleep quality index
时间窗: 1 week: the time between the questionnaire results at the beginning andcompared to the results after using the tegaderm patch and the results after using the lidoderm patch
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 lidoderm treatment improves the results of Pittsburgh sleep quality index
tinnitus suffer - visual analogue scale (VAS)
时间窗: 1 week: the time between the questionnaire results at the beginning andcompared to the results after using the tegaderm patch and the results after using the lidoderm patch
Tinnitus suffer scale: A range of 1-10 scale. the patient choose which number reflects the best the degree in which the tinnitus causes the patient to suffer. the higher the score- the worse is the tinnitus
questionnaire results change- tinnitus handicap inventory
时间窗: 1 week: the time between the questionnaire results at the beginning andcompared to the results after using the tegaderm patch and the results after using the lidoderm patch
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 lidoderm patch treatment decreases the score of this questionnaire which means that lidoderm patch improves patients quality of life
tinnitus loudness- visual analogue scale (VAS)
时间窗: 1 week: the time between the questionnaire results at the beginning andcompared to the results after using the tegaderm patch and the results after using the lidoderm patch
Tinnitus loudness scale: A range of 1-10 scale. the patient choose which number reflects the loudness of the subjective tinnitus which the patients suffer from. the higher the number- the louder the tinnitus
次要结局
未报告次要终点