Spasmodic Dysphonia Pain

Mayo Clinic

Status and phase: Completed; Phase 3; Phase 2

Conditions: Spasmodic Dysphonia

Treatments: Device: Vibrating wand; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04648891

20-006889

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Spasmodic dysphonia with or without tremor
• Receiving botox as treatment via a transcricothyroid approach

Exclusion criteria

• Allergy to lidocaine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

Control

No Intervention group

Description:

Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia

Lidocaine

Experimental group

Description:

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).

Treatment:

Drug: Lidocaine

Vibrating Wand

Experimental group

Description:

Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach while using the vibrating wand.

Treatment:

Device: Vibrating wand