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