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NCT Number: NCT06986629

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, Egypt

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

+201156644369

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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.

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

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.

Primary outcomes

  1. assessment of change of quality of life

    Time frame: 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 outcomes

  1. assessment of change of pulmonary functions

    Time frame: 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.

  2. assessment of change of Mean platelet volume

    Time frame: at baseline and after 8 weeks

    Venous blood samples will be drawn to assess and calculate the average volume of individual platelets

  3. assessment of change of white blood cells count

    Time frame: at baseline and after 8 weeks

    Venous blood samples will be drawn to assess and calculate the white blood cells count

  4. assessment of change of headache pain severity

    Time frame: 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)

  5. assessment of change of total nasal symptoms

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Samar Said Abd AL-razek, physical therapist

CONTACT

[email protected]

+201156644369

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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