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临床试验/NCT04412733
NCT04412733已完成不适用

EFFECTIVENESS OF PULSED ULTRASOUND TREATMENT ON PATIENT WITH BELL'S PALSY, A DOUBLE-BLIND, RANDOMİZED, PLACEBO-CONTROLLED TRIAL

Fatih Sultan Mehmet Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
Sunnybrook Facial Grading System

研究概览

简要总结

Bell's palsy (idiopathic facial palsy) is the most common peripheral lesion of the cranial nerves and the most common mono-neuropathy. Therapeutic ultrasound (US) is among the commonly used physical modalities for treating musculoskeletal disorders. The effects of US are due to alteration of cell membrane activity, vascular wall permeability and facilitation of tissue healing. The aim of this study is to investigate the effect of pulsed US treatment in patients with Bell's palsy when added to superficial heating, massage and exercise therapies.

详细描述

In this double -blind, randomized placebo-controlled trial, 32 patients (aged 18-65 years) diagnosed as idiopathic facial palsy with appropriate criteria were included. All patients were evaluated with motor nerve conduction studies and electromyography at 3-4 weeks after the onset of paralysis and 3 months after the treatment. Paralytic side frontalis and orbicularis oris muscles were used for electrophysiological analysis. Electrophysiological examinations were performed by an experienced electromyographer who was blind to the patient's treatments. Patients were separated into two groups as Group 1 (pulsed ultrasound therapy) and Group 2 (sham). Both groups were undergone to a conservative treatment program (20 min hot pack, massage 20 min and facial expression exercises) for 3 weeks, 5 days a week. In group 1 pulsed US treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2, duration 5 min) were applied to the paralyzed facial muscles. The patients in group 2 received exactly the same procedure as the treatment group, except that the power switch was off. All treatments were applied for 5 days a week for 3 weeks by the same 5-cm2 head US device (Enraf-Nonius Sonopuls 434) and the same physiotherapist. Patients were assessed at baseline, after last session, and 3 months after the treatment. Sunnybrook Facial Grading System, House Brackmann Facial Grading System and Facial Disability Index and electrophysiologic parameters were used for outcome evaluation.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-65 years
  • Clinically diagnosed as Bell's palsy by an ear nose and throat specialist.

排除标准

  • Central nervous system pathology
  • Recurrent Bell's palsy
  • Diabetes mellitus
  • Contraindications of ultrasound treatment
  • Active infection
  • Pregnancy
  • Lactation
  • Open wound around application area

结局指标

主要结局

Sunnybrook Facial Grading System

时间窗: 3 months

Sunnybrook Facial Grading System is a scale used to assess facial function, and scores range from 0 (complete paralysis) to 100 (normal facial function). This scale provides a clinical score which combines a static and dynamic assessment of facial muscles with the degree of synkinesis.

Facial Disability Index

时间窗: 3 months

Facial Disability Index evaluates the disability of individuals with Bell's Palsy by a total of 10 questions which assess physical and social limitations.

Hause Brackman Facial Nerve Grading System

时间窗: 3 months

Hause Brackman Facial Nerve Grading System is based on a six-grade score ( I-VI) that offers a gross evaluation of facial motor function and also includes evaluation of sequelae.

次要结局

  • Electrophysiologic Changes(3 months)

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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