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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-40
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: pulsed electromagnetic therapyExperimental treatment 1 intervention
Group B: PhotobiostimulationActive comparator 1 intervention
Group C: Self-sinus massage techniqueActive comparator 1 intervention

Trial outcomes

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.

Time frame
at baseline and after 8 weeks

Secondary outcomes

1

assessment of change of pulmonary functions

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.

Time frame
at baseline and after 8 weeks
2

assessment of change of Mean platelet volume

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

Time frame
at baseline and after 8 weeks
3

assessment of change of white blood cells count

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

Time frame
at baseline and after 8 weeks
4

assessment of change of headache pain severity

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)

Time frame
at baseline and after 8 weeks

Other outcomes

Sponsors and contacts

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