Dysphonia Pain Perception Following Botulinum Toxin Injections

Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2025
Purpose: To determine if ice compress would decrease spasmodic dysphonia patients'perception of pain with botulinum toxin injection.Hypothesis: Patients will perceive lower levels of pain with applying ice compress.Justification: There is a lack of data in the available literature on patients' painperception with botulinum toxin injections and interventions used to decrease painperception. Applying ice compress (cryotherapy) has strong short‐term analgesic effectsfor various painful conditions, especially in the musculoskeletal system, like acutesports injury, post‐op orthopaedic surgery, and dental conditions. However, cryotherapyhas not been used much in otolaryngology. This study will provide insights on possibleuse of cryotherapy in this field.Objectives: The investigators aim to evaluate if there is any significant difference inpain perception of patients who undergo botulinum injection with application of icecompress prior to the injection.Research Design: This will be a prospective unblinded randomized controlled study withcross over design. Adductor SD patients will be recruited from the UBC Pacific VoiceClinic run by PI, Dr. Amanda Hu. Interested patients will be provided more informationregarding the study and will be consented during their clinic visit. Recruited patientswill receive transcutaneous transcricothyroid injection of botulinum toxin withalternating use of no anesthesia (control) or ice compress (intervention) in twoconsecutive laryngeal injections, which most patients receive every 3‐4 months.Intervention for the purpose of this study will be applying ice compress to neck for 5minutes prior to botulinum toxin injection. Ten minutes after the procedure, patientswill complete the short form McGill Pain Questionnaire. Pain scores will be compared foreach participant with ice compress and without the ice compress. the investigators willalso collect other factors that may affect pain from the medical charts as follows: Age,gender, body mass index, employment status (employed vs unemployed), Voice HandicapIndex, opioid usage (yes/no), psychiatric medications (yes/no), chronic pain history(yes/no), duration of diagnosis, botox injection dose, bilateral/unilateral, firstinjection vs subsequent injection, professional voice user (yes/no), ever smoker (currentand former vs never), completion of procedure (yes/no). The investigators will asses ifthere is a significant relationship between any of these factors and SD patients' painperception.
Epistemonikos ID: 1c09f83d2a034fcbb782ed718ad2938f30185fed
First added on: Feb 01, 2025