Trial Outcomes & Findings for Spasmodic Dysphonia Pain (NCT NCT04648891)
NCT ID: NCT04648891
Last Updated: 2024-05-23
Results Overview
Measured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
32 participants
Primary outcome timeframe
6 months
Results posted on
2024-05-23
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
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
|
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
|
|---|---|---|---|---|---|---|
|
First Experimental Visit
STARTED
|
5
|
8
|
6
|
5
|
2
|
6
|
|
First Experimental Visit
COMPLETED
|
5
|
8
|
6
|
5
|
2
|
6
|
|
First Experimental Visit
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Experimental Visit
STARTED
|
5
|
8
|
6
|
5
|
2
|
6
|
|
Second Experimental Visit
COMPLETED
|
5
|
8
|
6
|
5
|
2
|
6
|
|
Second Experimental Visit
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Experimental Visit
STARTED
|
5
|
8
|
6
|
5
|
2
|
6
|
|
Third Experimental Visit
COMPLETED
|
5
|
8
|
6
|
5
|
2
|
6
|
|
Third Experimental Visit
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Laryngeal Injection of Botox Via a Transcricothyroid Approach
n=32 Participants
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
|
|---|---|
|
Age, Continuous
|
68 years
n=32 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=32 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants
|
PRIMARY outcome
Timeframe: 6 monthsMeasured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain
Outcome measures
| Measure |
Laryngeal Injection of Botox Via a Transcricothyroid Approach
n=32 Participants
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
|
|---|---|
|
Pain Experienced
Control
|
2 score on a scale
Interval 1.0 to 3.0
|
|
Pain Experienced
Lidocaine
|
2 score on a scale
Interval 1.0 to 3.5
|
|
Pain Experienced
Vibrating Wand
|
2 score on a scale
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: 6 monthsSubjects were asked which technique (Control, Lidocaine or Vibrating wand) they preferred the most
Outcome measures
| Measure |
Laryngeal Injection of Botox Via a Transcricothyroid Approach
n=32 Participants
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
|
|---|---|
|
Subject Preference
Control
|
6 Participants
|
|
Subject Preference
Lidocaine
|
12 Participants
|
|
Subject Preference
Vibrating Wand
|
14 Participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vibrating Wand
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place