VoiceNCT07904988
Voice Therapy in Reactive Benign Vocal Fold Polyp and Injection of Steroid
A study testing Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice Therapy and Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroid in people with Voice and Therapy, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the efficacy between Voice Therapy and Injection of Steroid in Reactive Benign Vocal Fold polyp. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Voice, Therapy, Vocal Fold Polyp
- What is being tested?
- Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice Therapy and Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2022to 30 Nov 2023
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients over age 18 years of age.
- Patients with benign primary lesion as ( polyps, nodules, cysts, singer's nodule and papilloma). And the reactive benign vocal lesion are polyps
- Reactive lesions showing small caliber (less than 50% width of true vocal fold in maximum dimension
Who cannot join
- Patients with recurrent vocal fold lesions
- Present or recurrent laryngeal carcinoma.
- Pregnancy.
- History of Allergy to corticosteroid preparations.
- Patients with cervical spondylosis, osteoarthritis, caries spine and those in whom direct laryngoscopy will be contraindicated.
- Patients with reactive vocal fold lesions as (nodules, cysts, and papilloma).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Voice Therapy in Reactive Benign Vocal Fold Polyp and Injection of Steroid
The aim of this study is to compare the efficacy between Voice Therapy and Injection of Steroid in Reactive Benign Vocal Fold polyp.
Read the detailed description
Benign lesions of the vocal fold are common. Standard clinical classification has included nodules, polyps, Reinke's edema, and cysts. More recently, fibrous masses and reactive lesions have been added. However, there is still no consensus on terminology, and this is especially true of benign traumatic bilateral vocal fold lesions . At times, definitive diagnosis can only be established intraoperatively, as Poels et al showed that bilateral lesions were found in 53% of patients preoperatively and in 82% of these patients when explored intraoperatively. It is essential to understand that accurate definition of benign bilateral vocal fold lesions guides prognosis and therapeutic planning.
Reactive lesions represent a difficult entity within bilateral vocal fold lesions . They are not well defined, their behavior is not well understood, and there is no consensus on the best treatment; therefore, proposing a standard nomenclature for the reactive lesion.
Different groups have attempted to characterize the entity. Some authors describe a contralateral reactive callus with epithelial hyperplasia caused by shearing forces of a unilateral vocal fold lesion.
Vocal polyps and cysts are generally unilateral, whereas reactive lesions are often found on the contralateral vocal fold directly opposite the primary lesion. A reactive vocal fold lesion must be paired with a contralateral vocal fold lesion. It may have a cup-and-saucer appearance, with the primary lesion indenting the reactive vocal fold lesion at the point of maximum contact. Reactive lesions may be more responsive to nonsurgical therapy because some clinical and video stroboscopic findings have indicated that the lesion is anatomically superficial. However, there is little support for this hypothesis.
Such lesions are common, especially among professional voice users, and can affect their quality of life. These lesions cause dysphonia, narrowed vocal range, and deteriorated voice quality, so selecting proper and effective treatment is important.
Conservative measures including voice rest and regular attendance of voice therapy sessions remain the first lines of treatment. However, compliance with voice therapy is usually poor, impairing treatment outcomes in the majority of cases .
The aim of this study is to compare the efficacy between Voice Therapy and Injection of Steroid in Reactive Benign Vocal Fold polyp.
- Conditions
- Voice, Therapy, Vocal Fold Polyp, Steroid Injection
- Being tested
- Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice Therapy, Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroid
- Keywords
- Steroid, Voice Therapy, Reactive Benign, Vocal Fold Polyp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice TherapyDevice
Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice Therapy
Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroidDrug
Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroid
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice Therapy | Experimental | Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice Therapy Receives: Device: Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice Therapy |
| Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroid | Experimental | Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroid Receives: Drug: Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laryngeal Clinical Examination by Grade, Roughness, Breathiness, Asthenia, Strain scales
The GRBAS scale consisted of five parameters, each rated on a four-point Likert scale (0 = no deviation, 1 = mild, 2 = moderate, 3 = severe).
Measured: after 1 month, 3 months, and 6 months
Secondary outcomes (1)
Voice evaluation by Modified GARBS SCALE
Modified GRBAS scale is a 4-degree scale, as follows:
Overall grade of dysphonia: "(0) Normal, (1) slight, (2) moderate, (3) severe" Character (quality): "strained- leaky- breathy- rough (irregular)" Pitch: "overall increase decrease- diplophonia" Loudness: "excessively loud- excessively soft fluctuating- average".
Measured: After 1 month, 3 months and 6 months from intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start30 Nov 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VoiceStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Abd Al-Gayed Fathy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904988
- Sponsor's protocol ID
- 35866/9/22
- Status last verified
- Nov 2022
- First submitted
- 24 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be available if it needed
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Voice Therapy in Reactive Benign Vocal Fold Polyp and Injection of Steroid
- ClinicalTrials.gov ID
- NCT07904988
- Acronym / sponsor ID
- 35866/9/22
- Conditions
- Voice, Therapy, Vocal Fold Polyp, Steroid Injection
- Keywords
- Steroid, Voice Therapy, Reactive Benign, Vocal Fold Polyp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 29 Oct 2026 (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.
The aim of this study is to compare the efficacy between Voice Therapy and Injection of Steroid in Reactive Benign Vocal Fold polyp.
Detailed description
Benign lesions of the vocal fold are common. Standard clinical classification has included nodules, polyps, Reinke's edema, and cysts. More recently, fibrous masses and reactive lesions have been added. However, there is still no consensus on terminology, and this is especially true of benign traumatic bilateral vocal fold lesions . At times, definitive diagnosis can only be established intraoperatively, as Poels et al showed that bilateral lesions were found in 53% of patients preoperatively and in 82% of these patients when explored intraoperatively. It is essential to understand that accurate definition of benign bilateral vocal fold lesions guides prognosis and therapeutic planning.
Reactive lesions represent a difficult entity within bilateral vocal fold lesions . They are not well defined, their behavior is not well understood, and there is no consensus on the best treatment; therefore, proposing a standard nomenclature for the reactive lesion.
Different groups have attempted to characterize the entity. Some authors describe a contralateral reactive callus with epithelial hyperplasia caused by shearing forces of a unilateral vocal fold lesion.
Vocal polyps and cysts are generally unilateral, whereas reactive lesions are often found on the contralateral vocal fold directly opposite the primary lesion. A reactive vocal fold lesion must be paired with a contralateral vocal fold lesion. It may have a cup-and-saucer appearance, with the primary lesion indenting the reactive vocal fold lesion at the point of maximum contact. Reactive lesions may be more responsive to nonsurgical therapy because some clinical and video stroboscopic findings have indicated that the lesion is anatomically superficial. However, there is little support for this hypothesis.
Such lesions are common, especially among professional voice users, and can affect their quality of life. These lesions cause dysphonia, narrowed vocal range, and deteriorated voice quality, so selecting proper and effective treatment is important.
Conservative measures including voice rest and regular attendance of voice therapy sessions remain the first lines of treatment. However, compliance with voice therapy is usually poor, impairing treatment outcomes in the majority of cases .
The aim of this study is to compare the efficacy between Voice Therapy and Injection of Steroid in Reactive Benign Vocal Fold polyp.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice Therapy | Experimental | Device: Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice TherapyGroup 1: Patients with reactive benign vocal fold polyp will be treated by Voice Therapy |
| Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroid | Experimental | Drug: Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroidGroup 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroid |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients over age 18 years of age.
- Patients with benign primary lesion as ( polyps, nodules, cysts, singer's nodule and papilloma). And the reactive benign vocal lesion are polyps
- Reactive lesions showing small caliber (less than 50% width of true vocal fold in maximum dimension
Key exclusion criteria (6 listed)
- Patients with recurrent vocal fold lesions
- Present or recurrent laryngeal carcinoma.
- Pregnancy.
- History of Allergy to corticosteroid preparations.
- Patients with cervical spondylosis, osteoarthritis, caries spine and those in whom direct laryngoscopy will be contraindicated.
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 |
|---|---|---|
| Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice TherapyGroup 1: Patients with reactive benign vocal fold polyp will be treated by Voice Therapy | Device | Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice Therapy |
| Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroidGroup 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroid | Drug | Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroid |
Primary outcome
Laryngeal Clinical Examination by Grade, Roughness, Breathiness, Asthenia, Strain scales
Time frame: after 1 month, 3 months, and 6 months
The GRBAS scale consisted of five parameters, each rated on a four-point Likert scale (0 = no deviation, 1 = mild, 2 = moderate, 3 = severe).
1 secondary outcome
Voice evaluation by Modified GARBS SCALE
Time frame: After 1 month, 3 months and 6 months from intervention
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 3 Nov 2026.
- Individual participant dataSharing planned: Yes. It will be available if it needed
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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 Group 1: Patients with reactive benign vocal fold polyp will be treated by Voice Therapy and Group 2: Patients with reactive benign vocal fold polyp will be treated by Injection of steroid in people with Voice and Therapy, run by Tanta University at 1 site in Egypt.
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 3 inclusion and 6 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 3 Nov 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 Egypt. 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?
Laryngeal Clinical Examination by Grade, Roughness, Breathiness, Asthenia, Strain scales (time frame: after 1 month, 3 months, and 6 months). 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 3 Nov 2026.