Skip to main content
OpenTrials
Completed

NCT Number: NCT04648891

Spasmodic Dysphonia Pain

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Allergy to lidocaine

Treatment and study plan

Lidocaine

Drug

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

Vibrating wand

Device

a vibrating instrument held adjacent to the cricothyroid space

Primary outcomes

  1. Pain Experienced

    Time frame: 6 months

    Measured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain

Secondary outcomes

  1. Subject Preference

    Time frame: 6 months

    Subjects were asked which technique (Control, Lidocaine or Vibrating wand) they preferred the most

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Spasmodic Dysphonia Pain Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2020
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.