NCT07063082

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 7, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2025

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

May 30, 2025

Last Update Submit

July 2, 2025

Conditions

Keywords

ErythromycinPhonophoresisultrasound

Outcome Measures

Primary Outcomes (1)

  • 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

    one month

Secondary Outcomes (1)

  • Computerized tomography scan (CTS)

    one month

Study Arms (3)

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.

Other: Erythromycin PhonophoresisOther: 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.

Device: Ultrasound (US)Drug: Topical ErythromycinOther: 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

Other: Medical treatment

Interventions

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.

Erythromycin Phonophoresis + Medical treatment

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).

Ultrasound + Topical Erythromycin + Medical treatment

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

Also known as: Erythromycin
Ultrasound + Topical Erythromycin + Medical treatment

Saline nasal wash 3 times daily for a month.

Erythromycin Phonophoresis + Medical treatmentMedical treatmentUltrasound + Topical Erythromycin + Medical treatment

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexanderia Police Hospital

Alexandria, Egypt

Location

MeSH Terms

Interventions

UltrasonographyErythromycin

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Nahla Mahmoud Elkassas, B.Sc

    Physotherapist at Alexanderia Police Hospital

    PRINCIPAL INVESTIGATOR
  • Hussein Gamal Hussein Mogahed, PhD

    Assistant Professor, Cairo university

    STUDY CHAIR
  • Mustafa Mohamed Abdelnaby, PhD

    Assistant Professor, Alexandria university

    STUDY DIRECTOR
  • Aya Gamal Fawzy Elsayed, PhD

    Lecturer, Cairo university

    STUDY DIRECTOR

Central Study Contacts

Nahla Mahmoud Elkassas, B.Sc

CONTACT

Aya Gamal Fawzy Elsayed, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 30, 2025

First Posted

July 14, 2025

Study Start

July 7, 2025

Primary Completion

September 7, 2025

Study Completion

September 15, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Locations