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临床试验/NCT05875298
NCT05875298尚未招募不适用

Implementation Of Physical Therapy Protocol In Management Of Chronic Maxillary Sinusitis :A Randomized Controlled Trial

Cairo University0 个研究点目标入组 66 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
66
主要终点
pressure pain threshold

研究概览

简要总结

this study will be conducted to investigate the effect of physical therapy protocol and medication on pain, pressure pain threshold and dysfunction in patients with Chronic Maxillary Sinusitis

详细描述

Rhino sinusitis is one of the most common health-care problems worldwide and its prevalence and incidence is increasing. Chronic Sinusitis is a big health problem worldwide that affects almost 15% of humans. The most affected sinus is the maxillary sinus as its drainage orifice through the hiatus semilunaris is badly placed near the roof of the sinus. The first line of treatment for sinusitis is mostly medical drugs including antimicrobial drugs, decongestants, nasal sprays, corticosteroids, and antihistamine drugs which can effectively dry the mucus. Physical therapy also offers a variety of treatment approaches for sinusitis. It includes various electrotherapy modalities, manual drainage techniques, suboccipital release for sinus headaches, needling, and rhino flow therapy. In spite of many studies and treatment approaches done on sinusitis, there are limitations faced in evidence of which approval is most effective, The objective of our study is to investigate the effect of physical therapy protocol in people with chronic maxillary sinusitis.sixty six patients with chronic maxillary sinusitis will be allocated randomly to three groups; one group will receive physical therapy protocol, second one will receive medication only and the third one will receive physical therapy protocol and medication for four weeks.

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
Double (Investigator, Outcomes Assessor)

盲法说明

opaque sealed envelop

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients clinically diagnosed by ENT Physician with chronic maxillary sinusitis With a history of 3 months or longer.
  • •Age group from 18 to 50 years

排除标准

  • •Local contraindications for face mobilization or massage. (abrasions, skin conditions, broken bones) Medical contraindications. (bacterial infections, conjunctivitis, styes)
  • •Duration of onset less than 2 months Headache due to reasons other than chronic sinusitis (TMJD, cervicogenic headache, underlying neurological diseases, anxiety-related, etc)
  • •Patients with surgery performed in the past 1 year for maxillary sinusitis Cognition level impairment
  • •Metal implants in the face region

研究组 & 干预措施

physical therapy protocol

Experimental

the patients will receive physical therapy protocol three times a week for four weeks

干预措施: physical therapy protocol (Other)

physical therapy protocol and medical drugs

Experimental

the patients will receive physical therapy protocol three times a week for four weeks and medication twice daily for four weeks

干预措施: physical therapy protocol and medical drugs (Other)

physical therapy protocol and medical drugs

Experimental

the patients will receive physical therapy protocol three times a week for four weeks and medication twice daily for four weeks

干预措施: medical drugs (Other)

medical drugs

Active Comparator

the patients will receive medical drugs twice daily for four weeks

干预措施: medical drugs (Other)

结局指标

主要结局

pressure pain threshold

时间窗: up to four weeks

pressure algometer will be used to measure pressure pain threshold

pain intensity

时间窗: up to four weeks

by visual analogue scale (VAS) 10 cm line with 2 ends, 0 and 10 ends 0 end means no pain 10 end means the worst pain

functional disability

时间窗: up to four weeks

Rhinosinusitis Disability Index will be used to assess functional disability in patients with chronic maxillary sinusitis.it consists of 30 items divided between three main domains: physical, functional, and emotional. Responses are provided using a 5-point Likert scale, and scores range from 0 to 150, with higher scores indicating that CRS exerts a greater impact on quality of life

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aya Saeed Halmy

principle investigator

Cairo University

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