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

NCT06986629 | Recruiting

• 1 other identifier: Samar-005562
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• assessment of change of quality of life

  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.

  at baseline and after 8 weeks

Secondary Outcomes (5)

• assessment of change of pulmonary functions

  at baseline and after 8 weeks

• assessment of change of Mean platelet volume

  at baseline and after 8 weeks

• assessment of change of white blood cells count

  at baseline and after 8 weeks

• assessment of change of headache pain severity

  at baseline and after 8 weeks

• assessment of change of total nasal symptoms

  at baseline and after 8 weeks

Study Arms (3)

pulsed electromagnetic therapy

EXPERIMENTAL

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

Device: pulsed electromagnetic therapy

Photobiostimulation

ACTIVE COMPARATOR

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

Device: Photobiostimulation

Self-sinus massage technique

ACTIVE COMPARATOR

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

Other: Self-sinus massage technique

Interventions

pulsed electromagnetic therapy 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.

pulsed electromagnetic therapy

Photobiostimulation 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

Photobiostimulation

Self-sinus massage technique 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.

Self-sinus massage technique

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants suffering from mild to moderate symptoms (baseline Total nasal symptoms score ≤ 9).
• Subjects age range from 20 to 40 years old.
• Patients of both sexes.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

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

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Samar Said Abd AL-razek, physical therapist

CONTACT

+201156644369; samar.said.alfiqy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: February 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)