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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine 10% | Experimental | 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 | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine 10 MG/ML | Drug | Application of 10% topical lidocaine in the external auditory canal of tinnitus patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately before and 5 minutes after receiving intervention on days 1 and 15 |
| 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. | Immediately before and 5 minutes after receiving intervention on days 1 and 15 |
| 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. | Immediately before and 5 minutes after receiving intervention on days 1 and 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo F Bento | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculdade de Medicina da Universidade de São Paulo | São Paulo | 01246903 | Brazil |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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%. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (Single Dose) |
| |||||||||||||
| Washout (2 Weeks) |
| |||||||||||||
| Second Intervention (Single Dose) |
|
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 15 days between each evaluation.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Immediately before and 5 minutes after receiving intervention on days 1 and 15 |
|
The adverse effects were collected up to 1 week after each intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine 10% | 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). Lidocaine 10 MG/ML: Application of 10% topical lidocaine in the external auditory canal of tinnitus patients. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tatiane Vacaro Campos | Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | +551126617585 | tati_vacaro@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2022 | Mar 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| C033657 | compact-colony-forming active substance |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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All patients will receive both lidocaine and placebo at an interval of 15 days and the order of application of the substances is randomized.
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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.
| Distilled water | Drug | Application of distilled water in the external auditory canal of tinnitus patients. |
|
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| NOT COMPLETED |
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| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tinnitus Handicap Inventory Score | The Tinnitus Handicap Inventory (THI) is a valuable self-report measure used to assess perceived tinnitus handicap severity. It consists of 25 items grouped into three subscales: functional, emotional, and catastrophic. The THI total score ranges from 0 to 100, with higher scores indicating greater tinnitus handicap severity. Very mild (score 0-16), Mild (score 18-36), Moderate (score 38-56), Severe (score 58-76), Catastrophic (score 78-100) | Mean | Standard Deviation | units on a scale |
|
| Study ear side right | Number | participants |
|
| Presence of pain | Count of Participants | Participants |
|
| Dizziness | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Systemic arterial hypertension | Count of Participants | Participants |
|
| Dyslipidemia | Count of Participants | Participants |
|
| Hypothyroidism | Count of Participants | Participants |
|
| Anxiety/Depression | Count of Participants | Participants |
|
| Cervical spina dysfunction | Cervical dysfunction was considered when the patient reported neck pain associated with image changes on cervical tomography or cervical magnetic resonance imaging. The measure used for this assessment was the presence (yes) or absence (no) of this type of dysfunction. | Count of Participants | Participants |
|
| Bruxism/temporomandibular dysfunction | Bruxism refers to the habit of grinding or clenching one's teeth, often unconsciously. It can occur during the day (awake bruxism) or at night (sleep bruxism). Temporomandibular dysfunction (TMD), on the other hand, encompasses a range of symptoms related to the temporomandibular joint (TMJ) and the surrounding muscles. These symptoms may include jaw pain, clicking, limited mouth opening, and headaches. We considered the patient's self-report as positive bruxism and as positive temporomandibular disorder when there was a diagnosis confirmed by a dentist. | Count of Participants | Participants |
|
| Study ear side left | Count of Participants | Participants |
|
| Presence of hearing loss | Count of Participants | Participants |
|
| Somatosensory tinnitus | Somatosensory tinnitus was considered positive when the following three conditions were present: tinnitus modulation through voluntary movements, somatic maneuvers, or tinnitus manipulation; onset of tinnitus associated with head and neck trauma or the onset of pain in the head and neck region; tinnitus accompanied by frequent neck pain, the presence of trigger points, the presence of muscle tension, temporomandibular disorder, or bruxism. | Count of Participants | Participants |
|
| OG001 | Placebo | 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). |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | decibels | Immediately before and 5 minutes after receiving intervention on days 1 and 15 |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | decibels | Immediately before and 5 minutes after receiving intervention on days 1 and 15 |
|
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Placebo | 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). Distilled water: Application of distilled water in the external auditory canal of tinnitus patients. | 0 | 29 | 0 | 29 | 0 | 29 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
Tinnitus loudness was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989). |
MML was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989). |