Mayo Clinic in Arizona
Phoenix, Arizona, 85054, United States
NCT Number: NCT04648891
This study aims to identify adjuvant methods to improve patient comfort during in-office laryngology procedures.
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Phoenix, Arizona, 85054, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subcutaneous injection 0.5cc 2% in 1:100,000 epinephrine
a vibrating instrument held adjacent to the cricothyroid space
Time frame: 6 months
Measured on a Visual Analogue Scale where 0 = no pain and 10 = worst pain
Time frame: 6 months
Subjects were asked which technique (Control, Lidocaine or Vibrating wand) they preferred the most
Mayo Clinic
Other
Spasmodic Dysphonia Pain Study
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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.
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