Patients With a Diagnosis of OdynophoniaPhase 4NCT05178485
Treatment Efficacy of Local Anesthetic/Steroid Mixture Injection for Patients With Odynophonia
A Phase 4 study testing Bupivacain and Normal Saline in people with Patients With a Diagnosis of Odynophonia, run by University of Texas Southwestern Medical Center.
Trial summary
This is a double-blind, randomized, placebo-controlled trial. A total of 40 subjects will be randomized to experimental group (receiving bupivacaine/triamcinolone mixture) or control group (receiving saline injection). Two injections will be given one week apart. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patients With a Diagnosis of Odynophonia
- What is being tested?
- Bupivacain and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 31 Dec 2027
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who report pain associated with voicing and are diagnosed with odynophonia
Who cannot join
- • Vocal fold mobility or tissue abnormality
- history of jaw surgery/TMJ
- history of neck surgery or trauma
- Uncontrolled reflux. (patient's scoring on Reflux Symptom Index(RSI) is 13 or higher: Normative data suggests that a RSI of greater than or equal to 13 is clinically significant.)
About this study
This is a double-blind, randomized, placebo-controlled trial. A total of 40 subjects will be randomized to experimental group (receiving bupivacaine/triamcinolone mixture) or control group (receiving saline injection). Two injections will be given one week apart. The primary outcome measure is the reduction in pain on the abbreviated McGill Pain Questionnaire (MPQ).
Read the detailed description
This is a double-blind, randomized, placebo-controlled trial. A total of 40 subjects will be randomized to experimental group (receiving bupivacaine/triamcinolone mixture) or control group (receiving saline injection). Two injections will be given one week apart. The primary outcome measure is the reduction in pain on the abbreviated McGill Pain Questionnaire (MPQ).
The injection of a mixture of local anesthetic/steroid into the thyrohyoid membrane to target the internal branch of superior laryngeal nerve (SLN) has been shown to be effective for some patients with chronic cough. Although anecdotal experience suggests this injection may also be effective in alleviating neck pain in patients with odynophonia (pain associated with voicing), there are no prospective studies to define the efficacy of this injection for odynophonia. The purpose of the study is to conduct a randomized, placebo-controlled study on the effect of local anesthetic/steroid injection for patients with odynophonia.
Recruitment/Consent Patients with a diagnosis of odynophonia seen at the UT Southwestern Voice Center will be informed of the study and given the opportunity to participate. Consent will be carried out by the study team members.
Randomization Subjects will be assigned a Study ID sequentially by the study coordinator upon enrollment. Each study ID (from Subject 01 to Subject 40) will be a priori assigned to either the experimental group or the control group using a randomization function in Excel.
Blinding Subjects will be blinded to group assignment. The physicians who are the treating providers of the subjects and who will perform the injections will also be blinded to group assignment. At each clinic visit for a subject's injection, the study coordinator will inform the clinic nurse of the group assignment, and the nurse will draw up the corresponding 2 mL injectate (either the bupivacaine/triamcinolone mixture or saline) and wrap the syringe in foil. The syringe will then be provided to the physician for the injection.
Injections Injections will be performed in the usual fashion as for standard of care injections commonly performed. The subject will be seated in the exam chair with the chair slightly inclined to extend the neck.
Only unilateral injections will be performed even for patients with bilateral pain, so that the dose is the same for all subjects. Patients with bilateral pain will be asked to choose one side for the injection for the duration of the study. The patients will only be billed for a regular clinic visit and not for the actual injections.
Subjects in the Experimental Group will received a 2 mL injection consisting of 1 mL of 0.5% bupivacaine (5 mg bupivacaine-HCL) and 1 mL Kenalog-40 (40 mg triamcinolone acetonide). Subjects in the Control Group will receive 2 mL saline. A 1.5-in, 25G or 27G needle will be used.
Outcome Instruments The treatment progress/outcome will be based on questionnaires (modified version of McGill-Melzack Pain Questionnaire, Numeric Pain Scale, Brief Pain Inventory, Vocal Tract Discomfort scale and Voice Handicap Index-10) and the clinician's auditory-perceptual and acoustic analysis of voice. The data will be taken during the initial evaluation, at each treatment session, and post-treatment.
- Conditions
- Patients With a Diagnosis of Odynophonia
- Being tested
- Bupivacain, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
Also called Kenalog-40
FDA approved drug
Normal SalineOther
FDA approved
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | At each clinic visit for a subject's injection, the study coordinator will inform the clinic nurse of the group assignment, and the nurse will draw up the corresponding 2 mL injectate (either the bupivacaine/triamcinolone mixture) and wrap the syringe in foil. The syringe will then be provided to the physician for the injection. Receives: Drug: Bupivacain |
| The control group | Placebo comparator | At each clinic visit for a subject's injection, the study coordinator will inform the clinic nurse of the group assignment, and the nurse will draw up the corresponding 2 mL saline and wrap the syringe in foil. The syringe will then be provided to the physician for the injection. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain on the McGill Pain Questionnaire
The McGill Pain Questionnaire (MPQ) is a valid and reliable measure of pain. The MPQ captures pain intensity on a 0 to 10 scale where 0 indicating no pain and 10 indicating severe pain
Measured: Baseline, Visit 2 (approximately 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Jul 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Halted prematurely prior to enrollment of first participant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With a Diagnosis of OdynophoniaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blind, randomized, placebo-controlled trial. A total of 40 subjects will be randomized to experimental group (receiving bupivacaine/triamcinolone mixture) or control group (receiving saline injection). Two injections will be given one week apart.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ted Mau, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178485
- Sponsor's protocol ID
- STU-2020-0443
- Status last verified
- Jul 2022
- First submitted
- 8 Dec 2021
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Efficacy of Local Anesthetic/Steroid Mixture Injection for Patients With Odynophonia
- ClinicalTrials.gov ID
- NCT05178485
- Acronym / sponsor ID
- STU-2020-0443
- Conditions
- Patients With a Diagnosis of Odynophonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Halted prematurely prior to enrollment of first participant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Jan 2022 (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.
This is a double-blind, randomized, placebo-controlled trial. A total of 40 subjects will be randomized to experimental group (receiving bupivacaine/triamcinolone mixture) or control group (receiving saline injection). Two injections will be given one week apart. The primary outcome measure is the reduction in pain on the abbreviated McGill Pain Questionnaire (MPQ).
Detailed description
This is a double-blind, randomized, placebo-controlled trial. A total of 40 subjects will be randomized to experimental group (receiving bupivacaine/triamcinolone mixture) or control group (receiving saline injection). Two injections will be given one week apart. The primary outcome measure is the reduction in pain on the abbreviated McGill Pain Questionnaire (MPQ).
The injection of a mixture of local anesthetic/steroid into the thyrohyoid membrane to target the internal branch of superior laryngeal nerve (SLN) has been shown to be effective for some patients with chronic cough. Although anecdotal experience suggests this injection may also be effective in alleviating neck pain in patients with odynophonia (pain associated with voicing), there are no prospective studies to define the efficacy of this injection for odynophonia. The purpose of the study is to conduct a randomized, placebo-controlled study on the effect of local anesthetic/steroid injection for patients with odynophonia.
Recruitment/Consent Patients with a diagnosis of odynophonia seen at the UT Southwestern Voice Center will be informed of the study and given the opportunity to participate. Consent will be carried out by the study team members.
Randomization Subjects will be assigned a Study ID sequentially by the study coordinator upon enrollment. Each study ID (from Subject 01 to Subject 40) will be a priori assigned to either the experimental group or the control group using a randomization function in Excel.
Blinding Subjects will be blinded to group assignment. The physicians who are the treating providers of the subjects and who will perform the injections will also be blinded to group assignment. At each clinic visit for a subject's injection, the study coordinator will inform the clinic nurse of the group assignment, and the nurse will draw up the corresponding 2 mL injectate (either the bupivacaine/triamcinolone mixture or saline) and wrap the syringe in foil. The syringe will then be provided to the physician for the injection.
Injections Injections will be performed in the usual fashion as for standard of care injections commonly performed. The subject will be seated in the exam chair with the chair slightly inclined to extend the neck.
Only unilateral injections will be performed even for patients with bilateral pain, so that the dose is the same for all subjects. Patients with bilateral pain will be asked to choose one side for the injection for the duration of the study. The patients will only be billed for a regular clinic visit and not for the actual injections.
Subjects in the Experimental Group will received a 2 mL injection consisting of 1 mL of 0.5% bupivacaine (5 mg bupivacaine-HCL) and 1 mL Kenalog-40 (40 mg triamcinolone acetonide). Subjects in the Control Group will receive 2 mL saline. A 1.5-in, 25G or 27G needle will be used.
Outcome Instruments The treatment progress/outcome will be based on questionnaires (modified version of McGill-Melzack Pain Questionnaire, Numeric Pain Scale, Brief Pain Inventory, Vocal Tract Discomfort scale and Voice Handicap Index-10) and the clinician's auditory-perceptual and acoustic analysis of voice. The data will be taken during the initial evaluation, at each treatment session, and post-treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- This is a double-blind, randomized, placebo-controlled trial. A total of 40 subjects will be randomized to experimental group (receiving bupivacaine/triamcinolone mixture) or control group (receiving saline injection). Two injections will be given one week apart.
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Experimental | Drug: BupivacainAt each clinic visit for a subject's injection, the study coordinator will inform the clinic nurse of the group assignment, and the nurse will draw up the corresponding 2 mL injectate (either the bupivacaine/triamcinolone mixture) and wrap the syringe in foil. The syringe will then be provided to the physician for the injection. |
| The control group | Placebo comparator | Other: Normal SalineAt each clinic visit for a subject's injection, the study coordinator will inform the clinic nurse of the group assignment, and the nurse will draw up the corresponding 2 mL saline and wrap the syringe in foil. The syringe will then be provided to the physician for the injection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who report pain associated with voicing and are diagnosed with odynophonia
Key exclusion criteria (4 listed)
- • Vocal fold mobility or tissue abnormality
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 |
|---|---|---|
| BupivacainAlso: Kenalog-40FDA approved drug | Drug | The experimental group |
| Normal SalineFDA approved | Other | The control group |
Primary outcome
Change in pain on the McGill Pain Questionnaire
Time frame: Baseline, Visit 2 (approximately 1 week)
The McGill Pain Questionnaire (MPQ) is a valid and reliable measure of pain. The MPQ captures pain intensity on a 0 to 10 scale where 0 indicating no pain and 10 indicating severe pain
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacain and Normal Saline in people with Patients With a Diagnosis of Odynophonia, run by University of Texas Southwestern Medical Center.
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: withdrawn, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in pain on the McGill Pain Questionnaire (time frame: Baseline, Visit 2 (approximately 1 week)). 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 28 Jul 2022.