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临床试验/NCT07661134
NCT07661134尚未招募不适用

Effect of Low Energy Extracorporeal Shockwave on Patients With Bell's Palsy

Cairo University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2026年6月25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
42
试验地点
1

研究概览

简要总结

This study aims to investigate the effect of low energy extracorporeal shock wave therapy on patients with Bell's palsy.

详细描述

Bell's palsy may range in severity from near-normal facial function to crippling facial disfigurement. It severity has been recognized to influence patient perceived quality of life to varying degrees. It yields myriad deficits affecting form and function. It can be a devastating and disfiguring condition, leading to psychological difficulties and restrictions of facial expressions, and may have a dramatic impact on interpersonal relationships. Facial nerve paralysis (FNP) often causes decreased quality of life and may lead to significant facial dysfunction. It is a health issue causing concern and has an extremely negative effect on both patients and their families. Main goals of treatment are to speed recovery, to make recovery more complete, to prevent corneal complications and other sequelae, and to inhibit viral replication. Psychological support is also essential. Patients require regular follow ups. Patients with Bell's palsy should be referred to a specialist and treatment should start as soon after onset as possible. In recent studies on peripheral nerves injuries, Low energy extracorporeal shock wave is a new tool for management. Extracorporeal shock wave therapy not only used in (urinary stone lithotripsy treatment, in the musculoskeletal field (lateral and medial epicondylitis, plantar fasciitis, calcific tendinitis of the shoulder, and bony union after fracture), muscle rigidity, muscular pain, knee degenerative arthritis, and lymphedema), but also used in regeneration of peripheral nerves. It causes molecular and biological changes, in addition to mechanical and physical stimulation. So in this study, we aim to determine the effect of low energy extracorporeal shock wave on Bell's palsy patients.

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 (Outcomes Assessor)

入排标准

年龄范围
45 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with unilateral Bell's palsy (only lower motor neuron lesion).
  • Patient with idiopathic or viral infection, Bell's palsy.
  • The age ranged from 45 to 55 years old.
  • Both males and females are included.
  • Body mass index (18.5-29.9kg/m2).
  • It includes the patient in the chronic stage.
  • All patients are assessed by NCS and other functional scales.
  • All patients will be referred by neurological consultants.
  • All patients have controlled diabetes mellitus and are medically stable.

排除标准

  • Patients with a history of facial paralysis post-stroke.
  • Patients with unstable medical conditions.
  • Patients with psychiatric disorders.
  • Patients with other neurological diseases.
  • Patients with other causes for Bell's palsy.
  • Patients with diabetic diseases.

研究组 & 干预措施

Low energy extracorporeal shockwave therapy + Selective physical therapy program

Experimental

This group will receive low energy extracorporeal shockwave therapy in addition to a selective physical therapy program (therapeutic exercise plus massage), 2 sessions per week for 6 weeks.

干预措施: Low energy extracorporeal shockwave therapy (Device)

Low energy extracorporeal shockwave therapy + Selective physical therapy program

Experimental

This group will receive low energy extracorporeal shockwave therapy in addition to a selective physical therapy program (therapeutic exercise plus massage), 2 sessions per week for 6 weeks.

干预措施: Selective physical therapy program (Other)

Selective physical therapy program

Active Comparator

This group will receive a selective physical therapy program (therapeutic exercise plus massage), 2 sessions per week for 6 weeks.

干预措施: Selective physical therapy program (Other)

研究者

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

Dina Hamdy Mahmoud Abd el Aziz

Principal Investigator

Cairo University

研究点 (1)

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