Spasmodic Dysphonia Pain
Primary Purpose
Spasmodic Dysphonia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lidocaine
Vibrating wand
Control
Sponsored by
About this trial
This is an interventional treatment trial for Spasmodic Dysphonia focused on measuring Pain
Eligibility Criteria
Inclusion Criteria:
- Spasmodic dysphonia with or without tremor
- Receiving botox as treatment via a transcricothyroid approach
Exclusion Criteria:
- Allergy to lidocaine
Sites / Locations
- Mayo Clinic in ArizonaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
Control
Lidocaine
Vibrating Wand
Arm Description
Patients will receive laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia
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)
Patients will receive laryngeal injection of Botox via a transcricothyroid approach while a vibrating instrument is held adjacent to cricothyroid space
Outcomes
Primary Outcome Measures
Change in pain experienced
Measured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04648891
Brief Title
Spasmodic Dysphonia Pain
Official Title
Spasmodic Dysphonia Pain Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to identify adjuvant methods to improve patient comfort during in-office laryngology procedures.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasmodic Dysphonia
Keywords
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
Patients will receive laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia
Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
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)
Arm Title
Vibrating Wand
Arm Type
Experimental
Arm Description
Patients will receive laryngeal injection of Botox via a transcricothyroid approach while a vibrating instrument is held adjacent to cricothyroid space
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Subcutaneous lidocaine injection prior to laryngeal injection
Intervention Type
Device
Intervention Name(s)
Vibrating wand
Intervention Description
Concomitant use of vibrating wand during laryngeal injection
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Laryngeal injection without additional anesthesia
Primary Outcome Measure Information:
Title
Change in pain experienced
Description
Measured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain
Time Frame
Baseline, 3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Spasmodic dysphonia with or without tremor
Receiving botox as treatment via a transcricothyroid approach
Exclusion Criteria:
- Allergy to lidocaine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Heyes, MBChB
Phone
480-342-2983
Email
Heyes.Richard@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Lott, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Spasmodic Dysphonia Pain
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