Dexamethasone Phonophoresis Versus Laser Acupuncture on Chronic Rhinosinusitis

September 25, 2024 updated by: Walaa Abd Elaziem Abd Elaziz, Cairo University
This study is designed to provide a comprehensive overview of evidence concerning the efficacy and safety of dexamethasone phonophoresis and laser acupuncture for treatment of chronic rhinosinusitis.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Giza
      • Dokki, Giza, Egypt, 12611
        • Faculty of physical therapy, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age range between 30 to 50 years.
  • Male and female patients will participate in the study.
  • All patients have chronic rhinosinusitis, who are experiencing 12 weeks or longer of 2 or more of the following signs and symptoms:

mucopurulent drainage (anterior, posterior, or both) nasal obstruction (congestion) facial pain-pressure-fullness, or decreased sense of smell

• All patients enrolled in the study will have their informed consent.

Exclusion Criteria:

  • Patients with metal implants (pacemakers, dental implants, or any other implants).
  • Patients with cancer, pregnancy or 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.
  • Patients with long-term use of corticosteroids or immunosuppressive agents.
  • Congenital defects on face and nose.
  • Fracture of nose or face.
  • Patients who are contraindicated for corticosteroids use in patient who will receive dexamethasone phonophoresis.
  • Allergic patients.
  • Pervious nasal surgery.
  • Patients with nasal septum deviation.
  • patients who had used antihistamines within 1 week, topical corticosteroids within2 weeks, systemic corticosteroids within 4 weeks, anti-cholinergic drugs within 3 days, antileukotriene drugs within 1 week, decongestants within 3 days, tricyclic antidepressants or phenothiazines within 2 weeks, non-steroidal analgesics within 2 weeks or any medication that may interfere with the objectives of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group (A)
Each participant in this group will receive dexamethasone phonophoresis, US with the use of 0.4% Dexamethasone sodium phosphate gel for phonophoresis. over maxillary and frontal sinuses for 3 sessions per week for one month, in addition to the traditional medication.
Combination product: Dexamethasone phonophoresis
Ultrasound therapeutic device with the use of 0.4% Dexamethasone sodium phosphate gel for phonophoresis.
Other: Traditional medication
Each participant in this group receive the traditional medication.
Experimental: Group (B)
Each participant in this group will receive low level laser placed in contact with the skin perpendicular over the body acupoints (LI 4) - (LI 20) - (EX- HN5) - (GV 20) - (GV 24) - (ST3) - (ST 7) in both sides and on (EX-HN3) acupoint, with a duration of 90 sec for each point three times per week for a month., in addition to the traditional medication.
Other: Traditional medication
Each participant in this group receive the traditional medication.
Device: Laser Acupuncture
low level laser therapy placed in contact with the skin perpendicular over the body acupoints (LI 4) - (LI 20) - (EX- HN5) - (GV 20) - (GV 24) - (ST3) - (ST 7) in both sides and on (EX-HN3) acupoint,
Active Comparator: Group (C)
Each participant in this group will receive the traditional medication only.
Other: Traditional medication
Each participant in this group receive the traditional medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sino nasal Outcome Test 22 (SNOT-22)
Time Frame: one month
This is a Quality Of Life Questionnaire specifically designed for sinusitis patient. It consists of 22 item sinus specific question which has to be administered to the patient and the total sum of all the items will be recorded based on the severity of the patient's condition and the scores will be calculated
one month
Computerized Tomography Scan
Time Frame: one month
CT scan will be used for assessment of mucosal thickening of maxillary sinuses, which is based on 0-3 system: 0 = clear, 1= mild or moderate mucosal thickening, 2 = severe mucosal thickening, 3 = total opacification
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Walaa Abd Elaziem Abd Elaziz Walaa Abd Elaziem Abd Elaziz, Doctoral degree, Cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

September 25, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005254

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

pre and post assessment measures results of:

  1. Sino nasal Outcome Test 22 (SNOT-22)
  2. Computerized Tomography Scan:

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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