Spasmodic Dysphonia Pain

Spasmodic Dysphonia Clinical Trial

Official title:

Spasmodic Dysphonia Pain Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648891
• Other study ID #: 20-006889
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 1, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Spasmodic dysphonia with or without tremor

• Receiving botox as treatment via a transcricothyroid approach

Exclusion Criteria:

• Allergy to lidocaine

Related Conditions & MeSH terms

• Dysphonia
• Hoarseness
• Spasmodic Dysphonia

Intervention

Drug:
• Lidocaine
Subcutaneous injection 0.5cc 2% in 1:100,000 epinephrine

Device:
• Vibrating wand
a vibrating instrument held adjacent to the cricothyroid space

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Experienced	Measured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain	6 months
Secondary	Subject Preference	Subjects were asked which technique (Control, Lidocaine or Vibrating wand) they preferred the most	6 months

External Links

•   Mayo Clinic Clinical Trials