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

NCT ID: NCT06986629

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-08-01

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

pulsed electromagnetic therapy

This group included twenty adults with chronic rhinosinusitis and received pulsed electromagnetic therapy. This treatment protocol will be carried out three times per week for 8 weeks

Group Type: EXPERIMENTAL

pulsed electromagnetic therapy

Intervention Type: DEVICE

We will use the ASTAR Physio MG 827, a generator and 75 cm solenoid couch, in a pulsed electromagnetic field group. Participants will be placed comfortably in the solenoid, and the device will be turned on and programmed for 20 guesses for 10 minutes, 7 Hz, three times per week for 8 weeks.

Photobiostimulation

This group included twenty adults with chronic rhinosinusitis and received low level laser therapy. This treatment protocol will be carried out three times per week for 8 weeks

Group Type: ACTIVE_COMPARATOR

Photobiostimulation

Intervention Type: DEVICE

The therapy will be performed using an ASTAR PhysioGo -As low level laser therapy device with a wavelength of 830 nm, 30 mW power output, and 1 J energy dose. Patients will be supine and wear laser safety goggles. The laser will be applied to six locations over the maxillary or frontal sinuses, administered in a continuous manner for 33 seconds per spot, totaling 198 seconds and 6 J per session

Self-sinus massage technique

This group included twenty adults with chronic rhinosinusitis and received the self-sinus massage technique only. This treatment protocol will be carried out three times per week for 8 weeks

Group Type: ACTIVE_COMPARATOR

Self-sinus massage technique

Intervention Type: OTHER

Participants are instructed to perform self-massage to their frontal and maxillary sinuses at home twice daily, in the morning and evening. For the frontal sinus, place the fingers above the eyebrows on either side of the forehead, and gently circular outward massage for three sets of 30 seconds, repeated twice a day.

Interventions

pulsed electromagnetic therapy

We will use the ASTAR Physio MG 827, a generator and 75 cm solenoid couch, in a pulsed electromagnetic field group. Participants will be placed comfortably in the solenoid, and the device will be turned on and programmed for 20 guesses for 10 minutes, 7 Hz, three times per week for 8 weeks.

Intervention Type: DEVICE

Photobiostimulation

The therapy will be performed using an ASTAR PhysioGo -As low level laser therapy device with a wavelength of 830 nm, 30 mW power output, and 1 J energy dose. Patients will be supine and wear laser safety goggles. The laser will be applied to six locations over the maxillary or frontal sinuses, administered in a continuous manner for 33 seconds per spot, totaling 198 seconds and 6 J per session

Intervention Type: DEVICE

Self-sinus massage technique

Participants are instructed to perform self-massage to their frontal and maxillary sinuses at home twice daily, in the morning and evening. For the frontal sinus, place the fingers above the eyebrows on either side of the forehead, and gently circular outward massage for three sets of 30 seconds, repeated twice a day.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Samar Said Abd Al-Razek Abd Al-Fattah

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

out-patient clinic, faculty of physical therapy, October University for Modern Sciences and Arts

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Samar Said Abd AL-razek, physical therapist

Role: CONTACT

samar.said.alfiqy@gmail.com

+201156644369

Facility Contacts

Samar Said October University for Modern Sciences and Arts, physical therapist

Role: primary

samar.said.alfiqy@gmail.com

+201156644369

Other Identifiers

Samar-005562

Identifier Type: -

Identifier Source: org_study_id