Dysphonia Pain Perception Following Botulinum Toxin Injections

NCT06767215 | Completed

• 1 other identifier: H24-03992
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

Spasmodic dysphonia (SD) is a chronic voice disorder which can cause a significant decrease in voice related quality of life with no cure. The most common treatment is botox injections in the larynx, with the effect lasting for about 3 months. The procedure is performed in awake, unsedated conditions therefore patients experience pain which in turn affects the tolerance of the procedure. The investigators seek to study whether applying ice compress immediately before the injection would decrease SD patients' perception of pain with botulinum toxin injection. This will be achieved by giving the patients pain questionnaires to complete 10 minutes after the procedure.

Conditions

Spasmodic Dysphonia

Keywords

spamodic dysphonia; pain perception; ice compress

Outcome Measures

Primary Outcomes (1)

• Pain score

  Patients will be asked to complete Short Form McGill Questionnaire (SF-MPQ) pain questionnaire that has a visual acuity pain (VAS) score integrated in it to obtain pain level. The minimum and maximum levels of scale are 0 and 100 and higher scores mean worse pain levels.

  10 min after the injection.

Study Arms (2)

Botulinium injection with ice compress

EXPERIMENTAL

Other: Ice Compress

Botulium injection without ice compress

ACTIVE COMPARATOR

Other: No ice compress

Interventions

Ice Compress OTHER

Ice compress will be applied 5 minutes before butulinium injection

Botulinium injection with ice compress

No ice compress OTHER

No ice compress will be applied .

Botulium injection without ice compress

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 years old and older) with adductor spasmodic dysphonia who present to the UBC Pacific Voice clinic for botulinum toxin injections.

You may not qualify if:

• Patients with abductor or mixed spasmodic dysphonia
• Patients who do not speak English
• Patients without the mental capacity to complete the study
• Patients less than 18 years of age

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Dimond Healthcare Center

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 9, 2025
• Study Start: March 4, 2025
• Primary Completion: December 24, 2025
• Study Completion: January 25, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

CA (1)