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

Обзор

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.

Подробное описание

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

Вмешательства

• Устройство 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.
• Устройство 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
• Другое 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.

Первичные конечные точки

• assessment of change of quality of life [Срок оценки: at baseline and after 8 weeks]

Вторичные конечные точки (5)

• assessment of change of pulmonary functions [Срок оценки: at baseline and after 8 weeks]
• assessment of change of Mean platelet volume [Срок оценки: at baseline and after 8 weeks]
• assessment of change of white blood cells count [Срок оценки: at baseline and after 8 weeks]
• assessment of change of headache pain severity [Срок оценки: at baseline and after 8 weeks]
• assessment of change of total nasal symptoms [Срок оценки: at baseline and after 8 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• out-patient clinic, faculty of physical therapy, October University for Modern Sciences an — Cairo

Идентификаторы

NCT: NCT06986629 · Samar-005562

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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