Spasmodic Dysphonia
Conditions
Keywords
Pain
Brief summary
This study aims to identify adjuvant methods to improve patient comfort during in-office laryngology procedures.
Detailed description
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.
Interventions
DRUGLidocaine
Subcutaneous injection 0.5cc 2% in 1:100,000 epinephrine
DEVICEVibrating wand
a vibrating instrument held adjacent to the cricothyroid space
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Spasmodic dysphonia with or without tremor * Receiving botox as treatment via a transcricothyroid approach
Exclusion criteria
\- Allergy to lidocaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Experienced | 6 months | Measured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Preference | 6 months | Subjects were asked which technique (Control, Lidocaine or Vibrating wand) they preferred the most |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Laryngeal Injection of Botox Via a Transcricothyroid Approach | — |
|---|---|---|
| Age, Continuous | 68 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 32 participants | — |
| Sex: Female, Male Female | 24 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 | 0 / 32 |
Outcome results
Primary
Pain Experienced
Measured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain
Time frame: 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Laryngeal Injection of Botox Via a Transcricothyroid Approach | Pain Experienced | Control | 2 score on a scale |
| Laryngeal Injection of Botox Via a Transcricothyroid Approach | Pain Experienced | Lidocaine | 2 score on a scale |
| Laryngeal Injection of Botox Via a Transcricothyroid Approach | Pain Experienced | Vibrating Wand | 2 score on a scale |
Secondary
Subject Preference
Subjects were asked which technique (Control, Lidocaine or Vibrating wand) they preferred the most
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Laryngeal Injection of Botox Via a Transcricothyroid Approach | Subject Preference | Control | 6 Participants |
| Laryngeal Injection of Botox Via a Transcricothyroid Approach | Subject Preference | Lidocaine | 12 Participants |
| Laryngeal Injection of Botox Via a Transcricothyroid Approach | Subject Preference | Vibrating Wand | 14 Participants |