Tinnitus, Subjective
Conditions
Keywords
tinnitus, lidocaine, tinnitus treatment, tinnitus diagnosis, tinnitus suppression
Brief summary
The main objective of this clinical trial placebo controled is to evaluate the action of intraauricular topical lidocaine on tinnitus. The question to be answered is whether lidocaine is superior to placebo (distilled water) in reducing tinnitus intensity when applied topically within the external auditory canal. Tinnitus intensity will be measured using the visual analog scale and acuphenometry before and after lidocaine or placebo application.
Detailed description
Adult patients who have had continuous, uni or bilateral tinnitus, for at least 6 months are being evaluated. Exclusion criteria are: otological infection, tympanic membrane perforation, anatomical alteration of the external ear, pulsatile tinnitus, objective tinnitus, known allergy to lidocaine or other topical anesthetic and pregnancy All patients receive both lidocaine and placebo at an interval of 15 days and the order of application of the substances is randomized. Only one ear receives the medications and side is defined by the higher intensity of tinnitus, or through draw in the case of symmetrical tinnitus. The patient is instructed to lie in lateral decubitus, with the ear under study facing upwards and the substances are applied by filling the external auditory canal with lidocaine or distilled water for 5 min. Tinnitus intensity is measured (acuphenometry and VAS) before and after substance application and the variation is compared between lidocaine and placebo.
Interventions
Application of 10% topical lidocaine in the external auditory canal of tinnitus patients.
DRUGDistilled water
Application of distilled water in the external auditory canal of tinnitus patients.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Masking description
This is a double blind study. The substances are produced by the same handling pharmacy and delivered in identical vials, only with the information: substance 1 and substance 2.
Intervention model description
All patients will receive both lidocaine and placebo at an interval of 15 days and the order of application of the substances is randomized.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients who have had continuous, uni or bilateral tinnitus, for at least 6 months
Exclusion criteria
* Otological infection * Tympanic membrane perforation * Anatomical alteration of the external ear * Pulsatile tinnitus * Objective tinnitus * Known allergy to lidocaine or other topical anesthetic and pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue Scale (VAS) Score | Immediately before and 5 minutes after receiving intervention on days 1 and 15 | scale ranging from 0 to 10 points used to measure the intensity of tinnitus, where zero corresponds to the absence of tinnitus perception and 10 corresponds to the largest volume that the patient imagines that tinnitus may have. |
| Change in Tinnitus Loudness | Immediately before and 5 minutes after receiving intervention on days 1 and 15 | Acuphenometry is a psychoacoustic test performed in an audiometry booth to measure tinnitus intensity. By comparing the intensity of tinnitus with the intensity sounds offered by the researcher, the tinnitus loudness is defined. Tinnitus loudness is measured in decibels and the higher the value found, the louder the tinnitus intensity. |
| Change in Minimum Masking Level (MML) | Immediately before and 5 minutes after receiving intervention on days 1 and 15 | Acuphenometry is a psychoacoustic test performed in an audiometry booth to measure minimum masking level. By comparing the intensity of tinnitus with the intensity sounds offered by the researcher, the minimum stimulus that masks tinnitus is determined. The minimum masking level is the intensity that an external sound must have to cover up tinnitus until it is no longer perceived by the patient. MML is measured in decibels. The lower the MML value, the more easily tinnitus can be masked, suggesting a lower degree of discomfort for the patient. |
Countries
Brazil
Participant flow
Recruitment details
The selected subjects were patients of an otolaryngology center who sought care for tinnitus complaints between April 7, 2021, to April 6, 2022. Of them, 113 patients met the inclusion criteria, and none of the exclusion criteria, and were invited to participate in the study through WhatsApp contact. Thirty-three patients responded and attended the initial appointment, one was excluded for having only pulsatile tinnitus on the day of the appointment. Thirty two were enrolled.
Pre-assignment details
Thirty-three patients responded and attended the initial appointment, one was excluded for having only pulsatile tinnitus on the day of the appointment. Thirty-two patients started the study, being divided into study group (n=16) or placebo (n=16) through randomization. Each patient was their own control because this was a crossover study with an interval of 2 weeks between each evaluation.
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine 10%, Then Placebo Lidocaine 10 MG/ML: Application of 10% topical lidocaine in the external auditory canal of tinnitus patients.
The patient is instructed to lie down in lateral decubitus, with the ear in study facing upwards and 10% lidocaine is applied to the external auditory canal, using an eyedropper, until its complete filling (approximate average of 2ml).
After an interval of 15 days the same procedure was done with placebo. | 16 |
| Placebo, Then Lidocaine 10% Distilled water: Application of distilled water in the external auditory canal of tinnitus patients.
The patient is instructed to lie down in lateral decubitus, with the ear in study facing upwards and distilled water is applied to the external auditory canal, using an eyedropper, until its complete filling (approximate average of 2ml).
After an interval of 15 days the same procedure was done with lidocaine. | 16 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Second Intervention (Single Dose) | Imperceptible tinnitus on the day of the assessment | 1 | 0 |
| Washout (2 Weeks) | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Placebo, Then Lidocaine 10% | Lidocaine 10%, Then Placebo | Total |
|---|---|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 13.06 | 52.4 years STANDARD_DEVIATION 14.22 | 54 years STANDARD_DEVIATION 13.7 |
| Anxiety/Depression | 6 Participants | 7 Participants | 13 Participants |
| Bruxism/temporomandibular dysfunction | 9 Participants | 9 Participants | 18 Participants |
| Cervical spina dysfunction | 9 Participants | 6 Participants | 15 Participants |
| Diabetes | 2 Participants | 2 Participants | 4 Participants |
| Dizziness | 3 Participants | 3 Participants | 6 Participants |
| Dyslipidemia | 7 Participants | 7 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 16 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hypothyroidism | 1 Participants | 1 Participants | 2 Participants |
| Presence of hearing loss | 3 Participants | 3 Participants | 6 Participants |
| Presence of pain | 7 Participants | 6 Participants | 13 Participants |
| Region of Enrollment Brazil | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 19 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 13 Participants |
| Somatosensory tinnitus | 7 Participants | 7 Participants | 14 Participants |
| Study ear side left | 10 Participants | 10 Participants | 20 Participants |
| Study ear side right | 6 participants | 6 participants | 12 participants |
| Systemic arterial hypertension | 3 Participants | 7 Participants | 10 Participants |
| Tinnitus Handicap Inventory Score | 29.25 units on a scale STANDARD_DEVIATION 13.06 | 33.87 units on a scale STANDARD_DEVIATION 21.31 | 31.4 units on a scale STANDARD_DEVIATION 17.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 29 |
| other Total, other adverse events | 0 / 31 | 0 / 29 |
| serious Total, serious adverse events | 0 / 31 | 0 / 29 |
Outcome results
Primary
Change in Minimum Masking Level (MML)
Acuphenometry is a psychoacoustic test performed in an audiometry booth to measure minimum masking level. By comparing the intensity of tinnitus with the intensity sounds offered by the researcher, the minimum stimulus that masks tinnitus is determined. The minimum masking level is the intensity that an external sound must have to cover up tinnitus until it is no longer perceived by the patient. MML is measured in decibels. The lower the MML value, the more easily tinnitus can be masked, suggesting a lower degree of discomfort for the patient.
Time frame: Immediately before and 5 minutes after receiving intervention on days 1 and 15
Population: The mean MML (decibels) was compared between lidocaine and the placebo before and after the administration of each substance to evaluate the effect of lidocaine on tinnitus.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lidocaine 10% | Change in Minimum Masking Level (MML) | MML before the application of the substances | 4 decibels | Standard Deviation 3 |
| Lidocaine 10% | Change in Minimum Masking Level (MML) | MML after the application of the substances | 3.7 decibels | Standard Deviation 2.9 |
| Placebo | Change in Minimum Masking Level (MML) | MML before the application of the substances | 4.8 decibels | Standard Deviation 2.4 |
| Placebo | Change in Minimum Masking Level (MML) | MML after the application of the substances | 3.8 decibels | Standard Deviation 2.2 |
Comparison: The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%.
Primary
Change in Tinnitus Loudness
Acuphenometry is a psychoacoustic test performed in an audiometry booth to measure tinnitus intensity. By comparing the intensity of tinnitus with the intensity sounds offered by the researcher, the tinnitus loudness is defined. Tinnitus loudness is measured in decibels and the higher the value found, the louder the tinnitus intensity.
Time frame: Immediately before and 5 minutes after receiving intervention on days 1 and 15
Population: The mean Tinnitus loudness (decibels) was compared between lidocaine and the placebo before and after the administration of each substance to evaluate the effect of lidocaine on tinnitus.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lidocaine 10% | Change in Tinnitus Loudness | Tinnitus loudness before application of substances | 7.2 decibels | Standard Deviation 7.8 |
| Lidocaine 10% | Change in Tinnitus Loudness | Tinnitus loudness after application of substances | 5.6 decibels | Standard Deviation 7.7 |
| Placebo | Change in Tinnitus Loudness | Tinnitus loudness before application of substances | 6.4 decibels | Standard Deviation 8.4 |
| Placebo | Change in Tinnitus Loudness | Tinnitus loudness after application of substances | 4.6 decibels | Standard Deviation 8.3 |
Comparison: The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%.
Primary
Change in Visual Analogue Scale (VAS) Score
scale ranging from 0 to 10 points used to measure the intensity of tinnitus, where zero corresponds to the absence of tinnitus perception and 10 corresponds to the largest volume that the patient imagines that tinnitus may have.
Time frame: Immediately before and 5 minutes after receiving intervention on days 1 and 15
Population: The mean VAS was compared between lidocaine and the placebo before and after the administration of each substance to evaluate the effect of lidocaine on tinnitus.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lidocaine 10% | Change in Visual Analogue Scale (VAS) Score | VAS before the application of the substances | 6.3 score on a scale | Standard Deviation 1.8 |
| Lidocaine 10% | Change in Visual Analogue Scale (VAS) Score | VAS after the application of the substances | 5.5 score on a scale | Standard Deviation 2.1 |
| Placebo | Change in Visual Analogue Scale (VAS) Score | VAS before the application of the substances | 6.3 score on a scale | Standard Deviation 2 |
| Placebo | Change in Visual Analogue Scale (VAS) Score | VAS after the application of the substances | 5.2 score on a scale | Standard Deviation 2.6 |
Comparison: The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%.