Spasmodic Dysphonia Pain

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04648891

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Spasmodic Dysphonia	Drug: Lidocaine Device: Vibrating wand Other: Control	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Spasmodic Dysphonia Pain Study

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Control Patients will receive laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia	Other: Control Laryngeal injection without additional anesthesia
Experimental: Lidocaine 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 Subcutaneous lidocaine injection prior to laryngeal injection
Experimental: Vibrating Wand Patients will receive laryngeal injection of Botox via a transcricothyroid approach while a vibrating instrument is held adjacent to cricothyroid space	Device: Vibrating wand Concomitant use of vibrating wand during laryngeal injection

Arm

Intervention/Treatment

Other: Control

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

Other: Control

Laryngeal injection without additional anesthesia

Experimental: Lidocaine

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

Subcutaneous lidocaine injection prior to laryngeal injection

Experimental: Vibrating Wand

Patients will receive laryngeal injection of Botox via a transcricothyroid approach while a vibrating instrument is held adjacent to cricothyroid space

Device: Vibrating wand

Concomitant use of vibrating wand during laryngeal injection

Outcome Measures

Primary Outcome Measures

Change in pain experienced [Baseline, 3 months, 6 months]
Measured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Allergy to lidocaine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Phoenix	Arizona	United States	85054

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: William Karle, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

William (Will) E. Karle, MD, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT04648891

Other Study ID Numbers:

20-006889

First Posted:

Dec 2, 2020

Last Update Posted:

Oct 1, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by William (Will) E. Karle, MD, Principal Investigator, Mayo Clinic

Pain

Additional relevant MeSH terms:

Dysphonia

Hoarseness

Lidocaine

Study Results

No Results Posted as of Oct 1, 2021