Trial Outcomes & Findings for Action of Intra-auricular Topical Lidocaine on Tinnitus (NCT NCT05711641)
NCT ID: NCT05711641
Last Updated: 2024-08-30
Results Overview
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.
COMPLETED
NA
32 participants
Immediately before and 5 minutes after receiving intervention on days 1 and 15
2024-08-30
Participant Flow
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.
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.
Participant milestones
| Measure |
Lidocaine 10%, Then Placebo
The patients underwent a single, topical intraauricular dose of lidocaine 10%. After a two-week washout, the same subjects underwent a single dose, topical intraauricular distilled water (placebo).
|
Placebo, Then lidocaíne 10%
The patients underwent a single, topical intraauricular dose of distilled water (placebo). After a two-week washout, the same subjects underwent a single dose, topical intra-auricular lidocaine 10%.
|
|---|---|---|
|
First Intervention (Single Dose)
STARTED
|
16
|
16
|
|
First Intervention (Single Dose)
COMPLETED
|
16
|
16
|
|
First Intervention (Single Dose)
NOT COMPLETED
|
0
|
0
|
|
Washout (2 Weeks)
STARTED
|
16
|
16
|
|
Washout (2 Weeks)
COMPLETED
|
14
|
15
|
|
Washout (2 Weeks)
NOT COMPLETED
|
2
|
1
|
|
Second Intervention (Single Dose)
STARTED
|
14
|
15
|
|
Second Intervention (Single Dose)
COMPLETED
|
13
|
15
|
|
Second Intervention (Single Dose)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Lidocaine 10%, Then Placebo
The patients underwent a single, topical intraauricular dose of lidocaine 10%. After a two-week washout, the same subjects underwent a single dose, topical intraauricular distilled water (placebo).
|
Placebo, Then lidocaíne 10%
The patients underwent a single, topical intraauricular dose of distilled water (placebo). After a two-week washout, the same subjects underwent a single dose, topical intra-auricular lidocaine 10%.
|
|---|---|---|
|
Washout (2 Weeks)
Lost to Follow-up
|
2
|
1
|
|
Second Intervention (Single Dose)
Imperceptible tinnitus on the day of the assessment
|
1
|
0
|
Baseline Characteristics
Action of Intra-auricular Topical Lidocaine on Tinnitus
Baseline characteristics by cohort
| Measure |
Lidocaine 10%, Then Placebo
n=16 Participants
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.
|
Placebo, Then Lidocaine 10%
n=16 Participants
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.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 14.22 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 13.06 • n=7 Participants
|
54 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Tinnitus Handicap Inventory Score
|
33.87 units on a scale
STANDARD_DEVIATION 21.31 • n=5 Participants
|
29.25 units on a scale
STANDARD_DEVIATION 13.06 • n=7 Participants
|
31.4 units on a scale
STANDARD_DEVIATION 17.1 • n=5 Participants
|
|
Study ear side right
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Presence of pain
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Dizziness
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Diabetes
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Systemic arterial hypertension
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Dyslipidemia
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Hypothyroidism
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Anxiety/Depression
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Cervical spina dysfunction
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Bruxism/temporomandibular dysfunction
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Study ear side left
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Presence of hearing loss
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Somatosensory tinnitus
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately before and 5 minutes after receiving intervention on days 1 and 15Population: 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.
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.
Outcome measures
| Measure |
Lidocaine 10%
n=31 Participants
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).
|
Placebo
n=29 Participants
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).
|
|---|---|---|
|
Change in Visual Analogue Scale (VAS) Score
VAS before the application of the substances
|
6.3 score on a scale
Standard Deviation 1.8
|
6.3 score on a scale
Standard Deviation 2.0
|
|
Change in Visual Analogue Scale (VAS) Score
VAS after the application of the substances
|
5.5 score on a scale
Standard Deviation 2.1
|
5.2 score on a scale
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: Immediately before and 5 minutes after receiving intervention on days 1 and 15Population: 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.
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.
Outcome measures
| Measure |
Lidocaine 10%
n=31 Participants
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).
|
Placebo
n=29 Participants
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).
|
|---|---|---|
|
Change in Tinnitus Loudness
Tinnitus loudness before application of substances
|
7.2 decibels
Standard Deviation 7.8
|
6.4 decibels
Standard Deviation 8.4
|
|
Change in Tinnitus Loudness
Tinnitus loudness after application of substances
|
5.6 decibels
Standard Deviation 7.7
|
4.6 decibels
Standard Deviation 8.3
|
PRIMARY outcome
Timeframe: Immediately before and 5 minutes after receiving intervention on days 1 and 15Population: 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.
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.
Outcome measures
| Measure |
Lidocaine 10%
n=31 Participants
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).
|
Placebo
n=29 Participants
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).
|
|---|---|---|
|
Change in Minimum Masking Level (MML)
MML before the application of the substances
|
4 decibels
Standard Deviation 3
|
4.8 decibels
Standard Deviation 2.4
|
|
Change in Minimum Masking Level (MML)
MML after the application of the substances
|
3.7 decibels
Standard Deviation 2.9
|
3.8 decibels
Standard Deviation 2.2
|
Adverse Events
Lidocaine 10%
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Tatiane Vacaro Campos
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place