Comparative Effects of Therapeutic Ultrasound and Sinus Massage in Chronic Rhinosinusitis: a Randomized Controlled Study
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
- Pain level
研究概览
简要总结
This is a randomized controlled trial. Previous studies show that both therapeutic ultrasound and sinus massage techniques have significant results in Chronic Rhinosinustis (CRS).
However, there is no comparative study carried out between these two to show which technique has more effects in CRS.
This study will determine their comparative effects on:
- Pain measured on Numerical pain rating scale
- Sinonasal symptoms measured on sino-nasal outcome test questionaire
- Quality of life measured on rhinosinusitis disability index (RSDI)
- Nasal inspiratory airflow measured on peak nasal inspiratory flow meter. Participants of chronic rhinosinusitis will be selected according to the diagnostic criteria of American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) and will be randomly allocated into three groups. All three group will continue to receive medical intervention. Additionally one group will receive therapeutic ultrasound while other group will receive sinus massage. Whereas third group will be control group and won't receive any additional treatment.
Data will be collected at Foundation University College of Physical Therapy and Fauji Foundation Hospital.
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
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-60 years
- •Both gender
- •Diagnosed patients of chronic rhinosinusitis referred by an ENT specialist
- •According to the AAO-HNS, patients are diagnosed with CRS if they had:
- •Two or more major symptoms for ≥12 weeks. Or
- •one major symptom with two minor symptoms for ≥12 weeks (19) Major clinical symptoms
- •Pain or pressure on the face
- •Nasal congestion
- •Mucopurulent rhinorrhea either anteriorly, posteriorly, or both
- •Hyposmia/anosmia Minor clinical symptoms
- •Pain in the dental area
- •Halitosis
- •Pain or pressure on the ear
排除标准
- •Nasal polyps
- •Current Medical conditions in which ultrasound is contraindicated (20)
- •Facial metal implants
- •Face or head tumor/cyst/malignancy
- •Deteriorated cognitive level
- •Previous surgery on the nose
- •Facial bone fracture
- •Reduced heat perception
- •Ischemic tissues
- •Skin allergies/lesions to the face
研究组 & 干预措施
Group A
All three groups will continue their prescribed steam protocol and medications by the ENT specialist Group A will additionally receive a therapeutic Ultrasound over the maxillary sinus
干预措施: Therapeutic Ultrasound (Procedure)
Group B
All three groups will continue their prescribed steam protocol and medications by the ENT specialist Group B will additionally receive, sinus massage (pressure & milking)
干预措施: Sinus Massage (Procedure)
Group C
All three groups will continue their prescribed steam protocol and medications by the ENT specialist Group C will not receive any other adjunct physical therapy treatment (control group)
干预措施: Control group (Procedure)
结局指标
主要结局
Pain level
时间窗: 4 weeks
The numeric pain rating scale will be used. The participants rate their pain from 0-10. Scoring: 0 shows no pain, whereas 10 represents the worst pain.
sino-nasal symptoms
时间窗: 6 weeks
Sino-nasal outcome test questionnaire for assessing sino-nasal symptoms The SNOT-22 is a 22-item treatment outcome measure designed for people with chronic sinonasal conditions. The SNOT-22 has been evaluated and is based on a Likert scale. Scoring: 0="No problem", 1="Very mild problem", 2="Mild or slight problem", 3="Moderate problem", 4="Severe problem", and 5="Problem as bad as it can be." Higher scores on SNOT-22 survey items indicate worse patient function or more severe symptoms (total score range: 0-110)
health-related quality of life (HRQL) in rhinosinusitis
时间窗: 6 weeks
Rhino Sinusitis Disability Index (RSDI) for measuring health-related quality of life (HRQL) in rhinosinusitis The purpose of this scale is to identify difficulties experienced due to nose or sinus problems. The Rhinosinusitis Disability Index (RSDI) has a total score range of 0-120 and consists of 30 items.
nasal inspiratory flow rate
时间窗: 6 weeks
Peak nasal inspiratory flow meter to evaluate nasal inspiratory flow rate during maximal inspiration It works when a patient inhales through the nose causing air to be drawn through the meter, a cursor moves along the scale to indicate the speed of inhalation. The flow rate achieved can be noted by checking the position of the cursor against the calibrated scale.
次要结局
未报告次要终点