Dexamethasone Phonophoresis Versus Laser Acupuncture on Chronic Rhinosinusitis

NCT06616792 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: P.T.REC/012/005254
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Rhinosinusitis (CRS)

Keywords

Dexamethasone Phonophoresis, Laser Acupuncture, Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (2)

• Sino nasal Outcome Test 22 (SNOT-22)

  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

  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

Study Arms (3)

Group (A)

EXPERIMENTAL

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; Other: Traditional medication

Group (B)

EXPERIMENTAL

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.

Device: Laser Acupuncture; Other: Traditional medication

Group (C)

ACTIVE COMPARATOR

Each participant in this group will receive the traditional medication only.

Other: Traditional medication

Interventions

Dexamethasone phonophoresis COMBINATION_PRODUCT

Ultrasound therapeutic device with the use of 0.4% Dexamethasone sodium phosphate gel for phonophoresis.

Group (A)

Laser Acupuncture DEVICE

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,

Group (B)

Traditional medication OTHER

Each participant in this group receive the traditional medication.

Group (A); Group (B); Group (C)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical therapy, Cairo University

Dokki, Giza Governorate, 12611, Egypt

Location

Related Publications (3)

• da Silva GS, Dos Santos Isoppo K. Therapeutic ultrasound as a treatment for chronic rhinosinusitis: A systematic review. Clin Respir J. 2021 Dec;15(12):1275-1285. doi: 10.1111/crj.13441. Epub 2021 Aug 29.

  PMID: 34423908 BACKGROUND

• Lee B, Kwon CY, Park MY. Acupuncture for the Treatment of Chronic Rhinosinusitis: A PRISMA-Compliant Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2022 Aug 31;2022:6429836. doi: 10.1155/2022/6429836. eCollection 2022.

  PMID: 36091598 BACKGROUND

• Naghdi S, Ansari NN, Varedi M, Fathali M, Zarrin M, Kashi-Alashti M, HasanNia F. Use of low-level laser therapy for patients with chronic rhinosinusitis: a single-blind, sham-controlled clinical trial. Lasers Med Sci. 2022 Dec 20;38(1):5. doi: 10.1007/s10103-022-03684-z.

  PMID: 36538169 BACKGROUND

Study Officials

• Walaa Abd Elaziem Abd Elaziz Walaa Abd Elaziem Abd Elaziz, Doctoral degree

  Cairo University

  PRINCIPAL INVESTIGATOR

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: Walaa Abd Elaziem Abd Elaziz

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: July 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-06

Locations

EG (1)