Clinical trial NCT06616792: Dexamethasone Phonophoresis Versus Laser Acupuncture on Chronic Rhinosinusitis
Official title: Dexamethasone Phonophoresis Versus Laser Acupuncture on Chronic Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Rhinosinusitis (CRS)
Keywords: Dexamethasone Phonophoresis, Laser Acupuncture, Chronic Rhinosinusitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sino nasal Outcome Test 22 (SNOT-22)
timeFrame: one month
measure: Computerized Tomography Scan
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Faculty of Physical therapy, Cairo University
state: Giza
Study officials:
affiliation: Cairo University
name: Walaa Abd Elaziem Abd Elaziz Walaa Abd Elaziem Abd Elaziz, Doctoral degree
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.