Effect of Photobiostimulation Versus Pulsed Electromagnetic Field on Quality of Life in Adults With Chronic Rhinosinusitis

Not Applicable

Recruiting

• Conditions: Photobiostimulation; Pulsed Electromagnetic Filed; Low Level Laser Therapy; Chronic Rhinosinusitis (Diagnosis); Quality of Life

• Registration Number: NCT06986629
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2025-02-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-07-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
assessment of change of quality of life	at baseline and after 8 weeks	The Sinonasal Outcome Test-22 questionnaire is a commonly used tool in clinical practice to assess patients' quality of life with chronic respiratory syndrome. It consists of 22 chronic respiratory syndrome-related items, ranging from 0 to 5, and categorizes them into physical symptoms (items 1-12) and health and quality of life (items 13-22), covering sleep function and psychological difficulties. It is easy to understand and complete.

Secondary Outcome Measures

Name	Time	Method
assessment of change of Mean platelet volume	at baseline and after 8 weeks	Venous blood samples will be drawn to assess and calculate the average volume of individual platelets
assessment of change of headache pain severity	at baseline and after 8 weeks	It will be used to evaluate headache pain severity using a standard horizontal scale as mild (1-3 on a visual analogue scale), moderate (4-6 on a visual analogue scale), severe (7-9 on a visual analogue scale) and very severe (10 on a visual analogue scale)
assessment of change of white blood cells count	at baseline and after 8 weeks	Venous blood samples will be drawn to assess and calculate the white blood cells count
assessment of change of pulmonary functions	at baseline and after 8 weeks	The Global Initiative for Chronic Obstructive Lung Disease 2010 guidelines outline a procedure for a spirometer. The patient is instructed to breathe in until their lungs feel full, then hold their breath tightly around the mouthpiece. The operator blasts the air out forcefully, encouraging the patient to continue. The procedure is repeated twice until three repeatable blows are obtained, with the best two readings within 150 mL or 5% of each other.
assessment of change of total nasal symptoms	at baseline and after 8 weeks	It is the sum of scores for nasal congestion, sneezing, nasal itching, and rhinorrhea at each time point, using a four-point scale (0-3). A score of 0 indicates no symptoms, a score of 1 indicates mild symptoms that are easily tolerated, a score of 2 indicates awareness of bothersome but tolerable symptoms, and a score of 3 indicates severe symptoms that interfere with daily activities. The total nasal symptoms scale is calculated by combining the scores for each symptom to a total of 12

Trial Locations

Locations (1)

out-patient clinic, faculty of physical therapy, October University for Modern Sciences and Arts; 🇪🇬 Cairo, Egypt