Efficacy Of Erythromycin Phonophoresis on Chronic Rhinosinusitis

Cairo University (CU)

Status: Not yet enrolling

Conditions: Chronic Rhinosinusitis

Treatments: Drug: Topical Erythromycin; Other: Medical treatment; Device: Ultrasound (US); Other: Erythromycin Phonophoresis

Study type: Interventional

Funder types: Other

Identifiers

NCT07063082

P.T.REC/012/005150

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Erythromycin Phonophoresis + Medical treatment

Experimental group

Description:

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.

Treatment:

Other: Erythromycin Phonophoresis

Other: Medical treatment

Ultrasound + Topical Erythromycin + Medical treatment

Active Comparator group

Description:

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.

Treatment:

Device: Ultrasound (US)

Other: Medical treatment

Drug: Topical Erythromycin

Medical treatment

Other group

Description:

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

Treatment:

Other: Medical treatment