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This study aims to identify adjuvant methods to improve patient comfort during in-office laryngology procedures.
Hypothesis:
The use of local anesthetic or vibrating instrument will decrease overall pain experienced by a patient with spasmodic dysphonia undergoing Botox injections.
Aims, purpose, or objectives:
To identify adjuvant methods to improve patient comfort during in-office laryngology procedures. Results demonstrated here should be transferrable to other transcutaneous in-office procedures in laryngology.
Background:
Spasmodic dysphonia is a vocal disorder characterized by uncontrollable voice breaks. Injection of botulinum neurotoxin into the laryngeal muscles is the mainstay of treatment. Patients require repeated treatments due to the temporary effect of botulinum neurotoxin. Laryngeal injections are commonly performed through the skin of the neck and can be associated with pain and discomfort. Local anesthetic administration prior to laryngeal injection is commonly performed in clinical practice, however its efficacy hasn't been evaluated and a third of surveyed otolaryngologists do not administer local anesthesia prior to the laryngeal injection of botulinum neurotoxin. Vibratory anesthesia involves the application of a local vibratory stimulus and has been found to reduce pain during various needle-related procedures. Vibratory anesthesia has not previous been evaluated for laryngeal injections.
This study will utilize the need for spasmodic dysphonia patients to receive repeated injections to incorporate a crossover design where patients receive three consecutive laryngeal injections of botulinum toxin experiencing injection without additional anesthesia, with local anesthesia, and with vibration anesthesia in a randomized order.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia | |
| Lidocaine | Experimental | Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach following subcutaneous injection of lidocaine (approximately 2 minutes before Botox injection). |
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| Vibrating Wand | Experimental | Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach while using the vibrating wand. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Subcutaneous injection 0.5cc 2% in 1:100,000 epinephrine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Experienced | Measured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Preference | Subjects were asked which technique (Control, Lidocaine or Vibrating wand) they preferred the most | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
- Allergy to lidocaine
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| Name | Affiliation | Role |
|---|---|---|
| David Lott, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Phoenix | Arizona | 85054 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Total of 32 participants were enrolled to receive all interventions; however, the order the intervention that was received was randomized. All subjects completed all study visits/interventions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control, Then Lidocaine, Then Vibrating Wand | At the first injection subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia. At the second injection subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach following subcutaneous injection of lidocaine (approximately 2 minutes before Botox injection). At the third injection Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach while using the vibrating wand. Lidocaine: Subcutaneous injection 0.5cc 2% in 1:100,000 epinephrine Vibrating wand: a vibrating instrument held adjacent to the cricothyroid space |
| FG001 | Control, Then Vibrating Wand, Then Lidocaine | At the first injection subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia. At the second injection subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach while using the vibrating wand. At the third injection subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach following subcutaneous injection of lidocaine (approximately 2 minutes before Botox injection). Vibrating wand: a vibrating instrument held adjacent to the cricothyroid space Lidocaine: Subcutaneous injection 0.5cc 2% in 1:100,000 epinephrine |
| FG002 | Lidocaine, Then Vibrating Wand, Then Control | At the first injection subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach following subcutaneous injection of lidocaine (approximately 2 minutes before Botox injection). At the second injection subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach while using the vibrating wand. At the third injection subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia. Lidocaine: Subcutaneous injection 0.5cc 2% in 1:100,000 epinephrine Vibrating wand: a vibrating instrument held adjacent to the cricothyroid space |
| FG003 | Lidocaine, Then Control, Then Vibrating Wand | At the first injection subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach following subcutaneous injection of lidocaine (approximately 2 minutes before Botox injection). At the second injection subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia. At the third injections subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach while using the vibrating wand. Lidocaine: Subcutaneous injection 0.5cc 2% in 1:100,000 epinephrine Vibrating wand: a vibrating instrument held adjacent to the cricothyroid space |
| FG004 | Vibrating Wand, Then Control, Then Lidocaine | At the first injection subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach while using the vibrating wand. At the second injection subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia. At the third injection subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach following subcutaneous injection of lidocaine (approximately 2 minutes before Botox injection). Vibrating wand: a vibrating instrument held adjacent to the cricothyroid space Lidocaine: Subcutaneous injection 0.5cc 2% in 1:100,000 epinephrine |
| FG005 | Vibrating Wand, Then Lidocaine, Then Control | At the first injection subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach while using the vibrating wand. At the second injection subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach following subcutaneous injection of lidocaine (approximately 2 minutes before Botox injection). At the third injection subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia. Vibrating wand: a vibrating instrument held adjacent to the cricothyroid space Lidocaine: Subcutaneous injection 0.5cc 2% in 1:100,000 epinephrine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Experimental Visit |
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| Second Experimental Visit |
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| Third Experimental Visit |
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Total of 32 participants were enrolled to receive all interventions; however, the order the intervention was received was randomized. All 32 subjects completed all study visits/interventions.
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| ID | Title | Description |
|---|---|---|
| BG000 | Laryngeal Injection of Botox Via a Transcricothyroid Approach | Subjects were randomized at screening to either receive nothing (control), Lidocaine injection prior to their Botox injection or Vibrating Wand held to their skin during the botox injection. Subjects attended three visits of the experiment on three separate days. For the three visits, the subjects received either nothing (control), Lidocaine injection prior to their Botox injection or Vibrating Wand held to their skin during the botox injection, (the order was randomized) Lidocaine: Subcutaneous injection 0.5cc 2% in 1:100,000 epinephrine Vibrating wand: a vibrating instrument held adjacent to the cricothyroid space |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Pain Experienced | Measured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
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Adverse Events were collected for all subjects for the first experimental visit, second experimental visit and third experimental visit to end of study for a total of approximately 6 months.
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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 | Control | Subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia at either the first, second, or third experimental visit |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David G. Lott, M.D. | Mayo Clinic | 480-342-2983 | Lott.David@mayo.edu |
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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 | Jul 5, 2020 | Apr 22, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055154 | Dysphonia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Vibrating wand |
| Device |
a vibrating instrument held adjacent to the cricothyroid space |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Subject Preference | Subjects were asked which technique (Control, Lidocaine or Vibrating wand) they preferred the most | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Lidocaine | Subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach followed by subcutaneous injection of lidocaine (approximately 2 minutes before Botox injection) at either the first, second, or third experimental visit Lidocaine: Subcutaneous injection 0.5cc 2% in 1:100,000 epinephrine | 0 | 32 | 0 | 32 | 0 | 32 |
| EG002 | Vibrating Wand | Subjects received standard of care laryngeal injection of Botox via a transcricothyroid approach while using the vibrating wand at either the first, second, or third experimental visit Vibrating wand: a vibrating instrument held adjacent to the cricothyroid space | 0 | 32 | 0 | 32 | 0 | 32 |
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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 |
| Title | Measurements |
|---|---|
|