Clinical trial NCT06986629: Effect of Photobiostimulation Versus Pulsed Electromagnetic Field on Quality of Life in Adults With Chronic Rhinosinusitis
Official title: Effect of Photobiostimulation Versus Pulsed Electromagnetic Field on Quality of Life in Adults With Chronic Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Photobiostimulation
Pulsed Electromagnetic Filed
Low Level Laser Therapy
Chronic Rhinosinusitis (Diagnosis)
Quality of Life
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was done to find out the effect of photobiostimulation and pulsed electromagnetic field in patients with chronic rhinosinusitis on:

* Quality of life.
* Pulmonary function.
* Mean platelet volume.
* headache .
* total nasal symptoms.

Detailed description: Chronic rhinosinusitis is a severe disease that significantly impacts a patient's quality of life, leading to significant economic impacts on healthcare resources and absenteeism. Symptoms interfere with daily activities and can lead to medication resistance. Treatment options like steroids, oral antibiotics, and sinus surgery are less effective, and disease recurrence remains high even after surgery. Alternative therapies like low-level laser therapy and pulsed electromagnetic filed have shown promise in improving symptoms and potentially making low-level laser therapy a non-invasive treatment for Chronic rhinosinusitis

Eligibility criteria: Inclusion Criteria:

1. Participants suffering from mild to moderate symptoms (baseline Total nasal symptoms score ≤ 9).
2. Subjects age range from 20 to 40 years old.
3. Patients of both sexes.
4. proven positive allergy test (skin prick test or multiple allergen simultaneous test) to any of the common perennial allergens such as dust mites, molds, insects, and animal dander within the last 12 months

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Patients with a definite deviated nasal septum, or history of operation within the last 6 months.
* Hypertension, diabetes mellitus, malignancy, active pulmonary tuberculosis, active respiratory disease like asthma, or other systemic diseases.
* Long-term use of corticosteroids or immunosuppressive agents.
* Participation in another clinical study within 30 days.
* Hyperthyroidism
* Patients who had used antihistamines within 1 week, topical corticosteroids within 2 weeks, systemic corticosteroids within 4 weeks, anticholinergic drugs within 3 days, antileukotriene drugs within 1 week, decongestants within 3 days, tricyclic antidepressants or phenothiazines within 2 weeks, nonsteroidal analgesics within 2 weeks, and other drugs that the researchers believed were inappropriate.
* Patients with Tattoos, moles and dark skin

Primary outcomes:
measure: assessment of change of quality of life
timeFrame: at baseline and after 8 weeks
Secondary outcomes:
measure: assessment of change of pulmonary functions
timeFrame: at baseline and after 8 weeks
measure: assessment of change of Mean platelet volume
timeFrame: at baseline and after 8 weeks
measure: assessment of change of white blood cells count
timeFrame: at baseline and after 8 weeks
measure: assessment of change of headache pain severity
timeFrame: at baseline and after 8 weeks
measure: assessment of change of total nasal symptoms
timeFrame: at baseline and after 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: out-patient clinic, faculty of physical therapy, October University for Modern Sciences and Arts
Study officials:
References: