Spasmodic Dysphonia Pain

Study Overview
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Brief Summary
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This study aims to identify adjuvant methods to improve patient comfort during in-office laryngology procedures.

Detailed Description
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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.

Official Title
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Spasmodic Dysphonia Pain Study

Conditions
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Spasmodic Dysphonia

Intervention / Treatment
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* Drug: Lidocaine
* Device: Vibrating wand
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spasmodic dysphonia with or without tremor Receiving botox as treatment via a transcricothyroid approach Exclusion Criteria: - Allergy to lidocaine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Patients will receive laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia | Other: Control<br>* Laryngeal injection without additional anesthesia<br>|
| Experimental: Lidocaine<br>Patients will receive laryngeal injection of Botox via a transcricothyroid approach following subcutaneous injection of 0.5cc 2% lidocaine in 1:100,000 epinephrine (done approximately 2 minutes before Botox injection) | Drug: Lidocaine<br>* Subcutaneous lidocaine injection prior to laryngeal injection<br>|
| Experimental: Vibrating Wand<br>Patients will receive laryngeal injection of Botox via a transcricothyroid approach while a vibrating instrument is held adjacent to cricothyroid space | Device: Vibrating wand<br>* Concomitant use of vibrating wand during laryngeal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain experienced | Measured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain | Baseline, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain