Efficacy Of Erythromycin Phonophoresis on Chronic Rhinosinusitis

NCT ID: NCT07063082

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-07

Study Completion Date

2025-09-15

Brief Summary

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The purpose of the study is to evaluate the therapeutic effect of erythromycin phonophoresis in reducing chronic rhinosinusitis.

Detailed Description

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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

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Chronic Rhinosinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Erythromycin Phonophoresis + Medical treatment

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.

Group Type EXPERIMENTAL

Erythromycin Phonophoresis

Intervention Type OTHER

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.

Medical treatment

Intervention Type OTHER

Saline nasal wash 3 times daily for a month.

Ultrasound + Topical Erythromycin + Medical treatment

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.

Group Type ACTIVE_COMPARATOR

Ultrasound (US)

Intervention Type 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 Erythromycin

Intervention Type DRUG

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 treatment

Intervention Type OTHER

Saline nasal wash 3 times daily for a month.

Medical treatment

This group includes 30 patients with chronic rhinosinusitis who will receive their medical treatment (saline nasal wash) 3 times daily for a month

Group Type OTHER

Medical treatment

Intervention Type OTHER

Saline nasal wash 3 times daily for a month.

Interventions

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Erythromycin Phonophoresis

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.

Intervention Type OTHER

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).

Intervention Type DEVICE

Topical 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

Intervention Type DRUG

Medical treatment

Saline nasal wash 3 times daily for a month.

Intervention Type OTHER

Other Intervention Names

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Erythromycin

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* Congenital defects on face and nose.
* Fracture of nose or face.
* Polypoidal patients.
* Allergic patients.
* Previous nasal surgery.
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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nahla mahmoud mohamed elkassas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nahla Mahmoud Elkassas, B.Sc

Role: PRINCIPAL_INVESTIGATOR

Physotherapist at Alexanderia Police Hospital

Hussein Gamal Hussein Mogahed, PhD

Role: STUDY_CHAIR

Assistant Professor, Cairo university

Mustafa Mohamed Abdelnaby, PhD

Role: STUDY_DIRECTOR

Assistant Professor, Alexandria university

Aya Gamal Fawzy Elsayed, PhD

Role: STUDY_DIRECTOR

Lecturer, Cairo university

Locations

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Alexanderia Police Hospital

Alexandria, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Nahla Mahmoud Elkassas, B.Sc

Role: CONTACT

01555996909

Aya Gamal Fawzy Elsayed, PhD

Role: CONTACT

Facility Contacts

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Nahla Mahmoud Elkassas, B.Sc

Role: primary

01555996909

Other Identifiers

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P.T.REC/012/005150

Identifier Type: -

Identifier Source: org_study_id

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