Chronic RhinosinusitisNCT07063082
Efficacy Of Erythromycin Phonophoresis on Chronic Rhinosinusitis
A study testing Erythromycin Phonophoresis, Ultrasound (US) and Topical Erythromycin in people with Chronic Rhinosinusitis, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to evaluate the therapeutic effect of erythromycin phonophoresis in reducing chronic rhinosinusitis. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- Erythromycin Phonophoresis, Ultrasound (US) and Topical Erythromycin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jul 2025to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range between 25-50 years.
- Male and female patients will participate in the study.
- All patients have chronic rhinosinusitis.
- All patients enrolled in the study will have their informed consent.
- CT will include at least affection of maxillary sinus.
Who cannot join
- Patients with pacemaker
- Patients diagnosed with cancer.
- Pregnant women
- Patients with impaired vascular circulation
- Patients who suffer from mental or psychological disorders.
- Patients with any systemic diseases that may interfere with the objectives of the study.
Show all 11Show fewer
- Congenital defects on face and nose.
- Fracture of nose or face.
- Polypoidal patients.
- Allergic patients.
- Previous nasal surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aya Gamal Fawzy Elsayed, PhD contact
Egypt1 site
Alexanderia Police Hospital
Alexandria
Nahla Mahmoud Elkassas, B.Sc, 01555996909, elkassasnahla@gemail.com
About this study
The purpose of the study is to evaluate the therapeutic effect of erythromycin phonophoresis in reducing chronic rhinosinusitis.
Read the detailed description
Chronic rhinosinusitis (CRS) is defined as "inflammation of the nose and the paranasal sinuses characterized by two or more symptoms, one of which should be either nasal blockage, obstruction, congestion or nasal discharge (anterior or posterior nasal drip) with/without facial pain or pressure, reduction or loss of smell, endoscopic signs of nasal polyps, mucopurulent discharge primarily from middle meatus, oedema, mucosal obstruction primarily in middle meatus and computed tomography (CT) changes (mucosal changes within the osteomata complex and/or sinuses)".
CRS may be a benign disorder, but it has significant morbidity. If not treated, the quality of life is poor. The condition is known to exacerbate asthma and can even lead to meningitis and brain abscess formation- which increases morbidity and mortality. Patients with chronic sinusitis who are treated usually have satisfactory outcomes. Symptom relief can be obtained after functional endoscopic sinus surgery in about 75% of patients who fail to respond to medical management. In rare cases, chronic sinusitis can result in orbital and intracranial infections, leading to visual and neurological deficits.
This study will design to provide a guideline about effect of erythromycin phonophoresis on chronic rhinosinusitis and to assist in planning ideal treatment program.
The treatment for chronic rhinosinusitis is realized through the use of medications such as corticosteroids, antibiotics and antimycotics or surgical procedures. However, treatments are not always effective, which makes patients adhere to other therapeutic modalities, including medicinal herbs, homeopathy and probiotics. A modality that stands out is the use of therapeutic ultrasound, which has shown promising results for its anti-inflammatory and antinociceptive activity.
- Conditions
- Chronic Rhinosinusitis
- Being tested
- Erythromycin Phonophoresis, Ultrasound (US), Topical Erythromycin, Medical treatment
- Keywords
- Erythromycin, Phonophoresis, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythromycin PhonophoresisOther
The procedures of ultrasound phonophoresis will be as follows: Patients will be positioned comfortably, sitting in a relaxed position. The physiotherapist will explain the treatment procedures to the patient. The device cables will be checked before each session. The treatment will last 5 minutes for each maxillary sinus. The frequency will be set to 1 MHz, and the intensity will be 1 W/Cm2 for the maxillary sinuses. The ultrasound will be pulsed, and the treatment will consist of 12 sessions, 3 days per week.
Ultrasound (US)Device
Therapeutic US is produced by a transducer composed of a piezoelectric crystal, which converts electric energy into alternating compression and rarefaction of sound waves at a frequency greater than 20 kHz. The amplitude of the US wave is proportional to the displacement of the US transducer head during each half cycle. The amplitude represents the wave energy.
The ultrasound waves penetrate the tissue on the way to the target organ and have two mechanisms of action (thermal and non-thermal), which may potentially work synergistically to reduce nasal symptoms (nasal blockage and secretions).
Topical ErythromycinDrug
Also called Erythromycin
Erythromycin is a 14-member macrolide originally discovered in the 1950s. It has broad-spectrum antimicrobial action, inhibiting bacterial protein synthesis. studies have shown that erythromycin has immunomodulatory and anti-inflammatory activity independent of its antimicrobial action Erythromycin is a broad-spectrum macrolide antibiotic, wherein its bactericidal effect occurs by the inhibition of protein synthesis. It is used for the treatment of infections affecting the skin and mucosa; it shows immunomodulatory characteristics
Medical treatmentOther
Saline nasal wash 3 times daily for a month.
| Study group | Role | What they receive |
|---|---|---|
| Erythromycin Phonophoresis + Medical treatment | Experimental | This group will include 30 patients with chronic rhinosinusitis who will receive Erythromycin phonophoresis 12 session, 3 days per week, and medical treatment (saline nasal wash) 3 times daily for a month. Receives: Other: Erythromycin Phonophoresis; Other: Medical treatment |
| Ultrasound + Topical Erythromycin + Medical treatment | Active comparator | This group will include 30 patients with chronic rhinosinusitis who will receive ultrasound followed by topical use of Erythromycin gel on nose 12 session , 3 days per week and medical treatment (saline nasal wash) 3 times daily for a month. Receives: Device: Ultrasound (US); Drug: Topical Erythromycin; Other: Medical treatment |
| Medical treatment | Other | This group includes 30 patients with chronic rhinosinusitis who will receive their medical treatment (saline nasal wash) 3 times daily for a month Receives: Other: Medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinusitis symptom score (SSS)
Sinusitis Symptom Scores will be based on a visual analogue scale (VAS) well established. In this method, the six symptoms will be assessed using a scale of 0±10, where zero represents no symptom and 10 represents the most severe symptom imaginable
Measured: one month
Secondary outcomes (1)
Computerized tomography scan (CTS)
CT scan (TOSHIBA, MODEL TSX-035A, INPUT POWER 50kVA), will assess the mucosal thickening of maxillary sinuses
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start7 Jul 2025 (estimated)
- Primary completion7 Sep 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nahla mahmoud mohamed elkassas, Cairo University
- Investigators
- Nahla Mahmoud Elkassas, B.Sc, Principal investigator, Physotherapist at Alexanderia Police HospitalHussein Gamal Hussein Mogahed, PhD, Study chair, Assistant Professor, Cairo universityMustafa Mohamed Abdelnaby, PhD, Study director, Assistant Professor, Alexandria universityAya Gamal Fawzy Elsayed, PhD, Study director, Lecturer, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063082
- Sponsor's protocol ID
- P.T.REC/012/005150
- Status last verified
- Jul 2025
- First submitted
- 30 May 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Erythromycin Phonophoresis on Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT07063082
- Acronym / sponsor ID
- P.T.REC/012/005150
- Conditions
- Chronic Rhinosinusitis
- Keywords
- Erythromycin, Phonophoresis, ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Jul 2025 (estimated)
- Primary completion
- 7 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 14 Jul 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.
The purpose of the study is to evaluate the therapeutic effect of erythromycin phonophoresis in reducing chronic rhinosinusitis.
Detailed description
Chronic rhinosinusitis (CRS) is defined as "inflammation of the nose and the paranasal sinuses characterized by two or more symptoms, one of which should be either nasal blockage, obstruction, congestion or nasal discharge (anterior or posterior nasal drip) with/without facial pain or pressure, reduction or loss of smell, endoscopic signs of nasal polyps, mucopurulent discharge primarily from middle meatus, oedema, mucosal obstruction primarily in middle meatus and computed tomography (CT) changes (mucosal changes within the osteomata complex and/or sinuses)".
CRS may be a benign disorder, but it has significant morbidity. If not treated, the quality of life is poor. The condition is known to exacerbate asthma and can even lead to meningitis and brain abscess formation- which increases morbidity and mortality. Patients with chronic sinusitis who are treated usually have satisfactory outcomes. Symptom relief can be obtained after functional endoscopic sinus surgery in about 75% of patients who fail to respond to medical management. In rare cases, chronic sinusitis can result in orbital and intracranial infections, leading to visual and neurological deficits.
This study will design to provide a guideline about effect of erythromycin phonophoresis on chronic rhinosinusitis and to assist in planning ideal treatment program.
The treatment for chronic rhinosinusitis is realized through the use of medications such as corticosteroids, antibiotics and antimycotics or surgical procedures. However, treatments are not always effective, which makes patients adhere to other therapeutic modalities, including medicinal herbs, homeopathy and probiotics. A modality that stands out is the use of therapeutic ultrasound, which has shown promising results for its anti-inflammatory and antinociceptive activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erythromycin Phonophoresis + Medical treatment | Experimental | Other: Erythromycin Phonophoresis, Other: Medical treatmentThis group will include 30 patients with chronic rhinosinusitis who will receive Erythromycin phonophoresis 12 session, 3 days per week, and medical treatment (saline nasal wash) 3 times daily for a month. |
| Ultrasound + Topical Erythromycin + Medical treatment | Active comparator | Device: Ultrasound (US), Drug: Topical Erythromycin, Other: Medical treatmentThis group will include 30 patients with chronic rhinosinusitis who will receive ultrasound followed by topical use of Erythromycin gel on nose 12 session , 3 days per week and medical treatment (saline nasal wash) 3 times daily for a month. |
| Medical treatment | Other | Other: Medical treatmentThis group includes 30 patients with chronic rhinosinusitis who will receive their medical treatment (saline nasal wash) 3 times daily for a month |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age range between 25-50 years.
- Male and female patients will participate in the study.
- All patients have chronic rhinosinusitis.
- All patients enrolled in the study will have their informed consent.
- CT will include at least affection of maxillary sinus.
Key exclusion criteria (11 listed)
- Patients with pacemaker
- Patients diagnosed with cancer.
- Pregnant women
- Patients with impaired vascular circulation
- Patients who suffer from mental or psychological disorders.
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 |
|---|---|---|
| Erythromycin PhonophoresisThe procedures of ultrasound phonophoresis will be as follows: Patients will be positioned comfortably, sitting in a relaxed position. The physiotherapist will explain the treatment procedures to the patient. The device cables will be checked before each session. The treatment will last 5 minutes for each maxillary sinus. The frequency will be set to 1 MHz, and the intensity will be 1 W/Cm2 for the maxillary sinuses. The ultrasound will be pulsed, and the treatment will consist of 12 sessions, 3 days per week. | Other | Erythromycin Phonophoresis + Medical treatment |
| Ultrasound (US)Therapeutic US is produced by a transducer composed of a piezoelectric crystal, which converts electric energy into alternating compression and rarefaction of sound waves at a frequency greater than 20 kHz. The amplitude of the US wave is proportional to the displacement of the US transducer head during each half cycle. The amplitude represents the wave energy. The ultrasound waves penetrate the tissue on the way to the target organ and have two mechanisms of action (thermal and non-thermal), which may potentially work synergistically to reduce nasal symptoms (nasal blockage and secretions). | Device | Ultrasound + Topical Erythromycin + Medical treatment |
| Topical ErythromycinAlso: ErythromycinErythromycin is a 14-member macrolide originally discovered in the 1950s. It has broad-spectrum antimicrobial action, inhibiting bacterial protein synthesis. studies have shown that erythromycin has immunomodulatory and anti-inflammatory activity independent of its antimicrobial action Erythromycin is a broad-spectrum macrolide antibiotic, wherein its bactericidal effect occurs by the inhibition of protein synthesis. It is used for the treatment of infections affecting the skin and mucosa; it shows immunomodulatory characteristics | Drug | Ultrasound + Topical Erythromycin + Medical treatment |
| Medical treatmentSaline nasal wash 3 times daily for a month. | Other | Erythromycin Phonophoresis + Medical treatment, Medical treatment, Ultrasound + Topical Erythromycin + Medical treatment |
Primary outcome
Sinusitis symptom score (SSS)
Time frame: one month
Sinusitis Symptom Scores will be based on a visual analogue scale (VAS) well established. In this method, the six symptoms will be assessed using a scale of 0±10, where zero represents no symptom and 10 represents the most severe symptom imaginable
1 secondary outcome
Computerized tomography scan (CTS)
Time frame: one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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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.
Aya Gamal Fawzy Elsayed, PhD contact
Nahla Mahmoud Elkassas, B.Sc principal investigator
Physotherapist at Alexanderia Police Hospital
Hussein Gamal Hussein Mogahed, PhD study chair
Assistant Professor, Cairo university
Mustafa Mohamed Abdelnaby, PhD study director
Assistant Professor, Alexandria university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erythromycin Phonophoresis, Ultrasound (US) and Topical Erythromycin in people with Chronic Rhinosinusitis, run by Cairo 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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 14 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nahla Mahmoud Elkassas, B.Sc (01555996909, elkassasnahla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinusitis symptom score (SSS) (time frame: one month). 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 14 Jul 2025.