Dysphonia Pain Perception Following Botulinum Toxin Injections
NCT ID: NCT06767215
Last Updated: 2025-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
125 participants
INTERVENTIONAL
2025-03-31
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Spasmodic Dysphonia Interviews
NCT06561334
BOTOX® Drug Use Investigation (Spasmodic Dysphonia)
NCT03543150
Effects of Vocal Exercises for Spasmodic Dysphonia
NCT03349086
Effect of Vocal Exercise After Botulinum Toxin Injection for Spasmodic Dysphonia
NCT00895063
The Effect of Vocal Rest Versus Vocalization Following Xeomin® Injections in Spasmodic Dysphonia
NCT03129087
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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' pain perception with botulinum toxin injections and interventions used to decrease pain perception. Applying ice compress (cryotherapy) has strong short-term analgesic effects for various painful conditions, especially in the musculoskeletal system, like acute sports injury, post-op orthopaedic surgery, and dental conditions. However, cryotherapy has not been used much in otolaryngology. This study will provide insights on possible use of cryotherapy in this field.
Objectives: The investigators aim to evaluate if there is any significant difference in pain perception of patients who undergo botulinum injection with application of ice compress prior to the injection.
Research Design: This will be a prospective unblinded randomized controlled study with cross over design. Adductor SD patients will be recruited from the UBC Pacific Voice Clinic run by PI, Dr. Amanda Hu. Interested patients will be provided more information regarding the study and will be consented during their clinic visit. Recruited patients will receive transcutaneous transcricothyroid injection of botulinum toxin with alternating use of no anesthesia (control) or ice compress (intervention) in two consecutive 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 5 minutes prior to botulinum toxin injection. Ten minutes after the procedure, patients will complete the short form McGill Pain Questionnaire. Pain scores will be compared for each participant with ice compress and without the ice compress. the investigators will also collect other factors that may affect pain from the medical charts as follows: Age, gender, body mass index, employment status (employed vs unemployed), Voice Handicap Index, opioid usage (yes/no), psychiatric medications (yes/no), chronic pain history (yes/no), duration of diagnosis, botox injection dose, bilateral/unilateral, first injection vs subsequent injection, professional voice user (yes/no), ever smoker (current and former vs never), completion of procedure (yes/no). The investigators will asses if there is a significant relationship between any of these factors and SD patients' pain perception.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Botulinium injection with ice compress
Ice Compress
Ice compress will be applied 5 minutes before butulinium injection
Botulium injection without ice compress
No ice compress
No ice compress will be applied .
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ice Compress
Ice compress will be applied 5 minutes before butulinium injection
No ice compress
No ice compress will be applied .
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Patients who do not speak English
3. Patients without the mental capacity to complete the study
4. Patients less than 18 years of age
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of British Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Amanda Hu
Principal Investigator
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H24-03992
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.