Spasmodic Dysphonia Pain

  • STATUS
    Recruiting
  • End date
    Apr 4, 2023
  • participants needed
    50
  • sponsor
    Mayo Clinic
Updated on 6 October 2021

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.

Details
Condition spasmodic dysphonia, Dysphonia
Treatment Control, lidocaine, Vibrating wand
Clinical Study IdentifierNCT04648891
SponsorMayo Clinic
Last Modified on6 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Allergy to lidocaine
Clear my responses

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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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