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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Low energy extracorporeal shockwave therapy
  Participants allocated to the experimental group will receive low-energy extracorporeal shockwave therapy (LE-ESWT) using a shockwave device set at a frequency of 10 Hz, energy intensity of 2.5, and a total dose of 2500 shockwaves per session. The treatment will be delivered to two sites along the facial nerve pathway, including the stylomastoid foramen (500 shockwaves) and a point located 1 cm anterior to the ear (2000 shockwaves). Each session will be administered for approximately 15 minutes
• Другое Selective physical therapy program
  Participants will receive a standardized physical therapy program including neuromuscular reeducation and massage therapy. Facial exercises will be performed in front of a mirror to improve symmetry and facial muscle control, with therapist assistance provided as needed. Massage therapy will be applied to the neck, scalp, and facial regions. Each treatment session will last approximately 30 minutes.

Первичные конечные точки

• CMAP Amplitude Asymmetry Percentage [Срок оценки: 6 weeks]

Вторичные конечные точки (1)

• House-Brackmann Facial Nerve Grading Scale [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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

• Faculty of Physical Therapy, Cairo University — Giza

Идентификаторы

NCT: NCT07661134 · P.T.REC/012/005544

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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