Effect of Photobiostimulation Versus Pulsed Electromagnetic Field on Quality of Life in Adults With Chronic Rhinosinusitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- assessment of change of quality of life
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: pulsed electromagnetic therapy (Device)
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
干预措施: Photobiostimulation (Device)
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
干预措施: Self-sinus massage technique (Other)
结局指标
主要结局
assessment of change of quality of life
时间窗: 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.
次要结局
- assessment of change of Mean platelet volume(at baseline and after 8 weeks)
- assessment of change of headache pain severity(at baseline and after 8 weeks)
- assessment of change of white blood cells count(at baseline and after 8 weeks)
- assessment of change of pulmonary functions(at baseline and after 8 weeks)
- assessment of change of total nasal symptoms(at baseline and after 8 weeks)
研究者
Samar Said Abd Al-Razek Abd Al-Fattah
principal investigator
Cairo University