A Phase 2/3 interventional study of Lidocaine and Vibrating wand in Spasmodic Dysphonia, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Mayo Clinic · Phase 2/3, Interventional, and Treatment
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.
132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.
This study's enrollment of 32 is close to the median of 30 across 87 interventional studies indexed under Dysphonia.
Browse Dysphonia studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
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Exclusion Criteria:
Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia
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).
Drug: Lidocaine
Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach while using the vibrating wand.
Device: Vibrating wand
Subcutaneous injection 0.5cc 2% in 1:100,000 epinephrine
a vibrating instrument held adjacent to the cricothyroid space
Pain Experienced
Measured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain
Time frame: 6 months
Subject Preference
Subjects were asked which technique (Control, Lidocaine or Vibrating wand) they preferred the most
Time frame: 6 months
| Milestone | Control, Then Lidocaine, Then Vibrating Wand | Control, Then Vibrating Wand, Then Lidocaine | Lidocaine, Then Vibrating Wand, Then Control | Lidocaine, Then Control, Then Vibrating Wand | Vibrating Wand, Then Control, Then Lidocaine | Vibrating Wand, Then Lidocaine, Then Control |
|---|---|---|---|---|---|---|
| Started | 5 | 8 | 6 | 5 | 2 | 6 |
| Completed | 5 | 8 | 6 | 5 | 2 | 6 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Control, Then Lidocaine, Then Vibrating Wand | Control, Then Vibrating Wand, Then Lidocaine | Lidocaine, Then Vibrating Wand, Then Control | Lidocaine, Then Control, Then Vibrating Wand | Vibrating Wand, Then Control, Then Lidocaine | Vibrating Wand, Then Lidocaine, Then Control |
|---|---|---|---|---|---|---|
| Started | 5 | 8 | 6 | 5 | 2 | 6 |
| Completed | 5 | 8 | 6 | 5 | 2 | 6 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Control, Then Lidocaine, Then Vibrating Wand | Control, Then Vibrating Wand, Then Lidocaine | Lidocaine, Then Vibrating Wand, Then Control | Lidocaine, Then Control, Then Vibrating Wand | Vibrating Wand, Then Control, Then Lidocaine | Vibrating Wand, Then Lidocaine, Then Control |
|---|---|---|---|---|---|---|
| Started | 5 | 8 | 6 | 5 | 2 | 6 |
| Completed | 5 | 8 | 6 | 5 | 2 | 6 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
Measured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain
| score on a scale | Laryngeal Injection of Botox Via a Transcricothyroid Approach |
|---|---|
| Control | 2 (1 to 3) |
| Lidocaine | 2 (1 to 3.5) |
| Vibrating Wand | 2 (1 to 3) |
Subjects were asked which technique (Control, Lidocaine or Vibrating wand) they preferred the most
| Participants | Laryngeal Injection of Botox Via a Transcricothyroid Approach |
|---|---|
| Control | 6 |
| Lidocaine | 12 |
| Vibrating Wand | 14 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Lidocaine | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Vibrating Wand | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
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.
| Age, Continuous(years) | Laryngeal Injection of Botox Via a Transcricothyroid Approach |
|---|---|
| Median | 68 (61 to 75) |
| Sex: Female, Male(Participants) | Laryngeal Injection of Botox Via a Transcricothyroid Approach |
|---|---|
| Female | 24 |
| Male | 8 |
| Race and Ethnicity Not Collected(Participants) | Laryngeal Injection of Botox Via a Transcricothyroid Approach |
|---|
| Region of Enrollment(participants) | Laryngeal Injection of Botox Via a Transcricothyroid Approach |
|---|---|
| United States | 32 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2021 to primary completion in Jul 2023, 23 months.
Results were first posted in May 2024, 10 months after primary completion.
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Studies of the drug tested here: Lidocaine