Spasmodic DysphoniaNCT06767215
Dysphonia Pain Perception Following Botulinum Toxin Injections
A study testing Ice Compress and No ice compress in people with Spasmodic Dysphonia, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasmodic Dysphonia
- What is being tested?
- Ice Compress and No ice compress
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteCanada
- Study dates
- 4 Mar 2025to 25 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years old and older) with adductor spasmodic dysphonia who present to the UBC Pacific Voice clinic for botulinum toxin injections.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spasmodic Dysphonia Patients' Perception of Pain With Botulinum Toxin Injections
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.
Read the detailed description
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' 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
- Spasmodic Dysphonia
- Being tested
- Ice Compress, No ice compress
- Keywords
- spamodic dysphonia, pain perception, ice compress
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice CompressOther
Ice compress will be applied 5 minutes before butulinium injection
No ice compressOther
No ice compress will be applied .
| Study group | Role | What they receive |
|---|---|---|
| Botulinium injection with ice compress | Experimental | Not described Receives: Other: Ice Compress |
| Botulium injection without ice compress | Active comparator | Not described Receives: Other: No ice compress |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 min after the injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start4 Mar 2025
- Primary completion24 Dec 2025
- Study completion25 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasmodic DysphoniaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Hu, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767215
- Sponsor's protocol ID
- H24-03992
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spasmodic Dysphonia Patients' Perception of Pain With Botulinum Toxin Injections
- ClinicalTrials.gov ID
- NCT06767215
- Acronym / sponsor ID
- H24-03992
- Conditions
- Spasmodic Dysphonia
- Keywords
- spamodic dysphonia, pain perception, ice compress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 24 Dec 2025 (actual)
- Study completion
- 25 Jan 2026 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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' 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinium injection with ice compress | Experimental | Other: Ice Compress |
| Botulium injection without ice compress | Active comparator | Other: No ice compress |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (18 years old and older) with adductor spasmodic dysphonia who present to the UBC Pacific Voice clinic for botulinum toxin injections.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ice CompressIce compress will be applied 5 minutes before butulinium injection | Other | Botulinium injection with ice compress |
| No ice compressNo ice compress will be applied . | Other | Botulium injection without ice compress |
Primary outcome
Pain score
Time frame: 10 min after the injection.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice Compress and No ice compress in people with Spasmodic Dysphonia, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 10 min after the injection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.