Multicenter Study of Thermal Radiofrequency Applied to the Musculocutaneous Nerve for the Treatment of Spasticity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Goniometry
研究概览
简要总结
This multicenter observational study evaluates the safety and effectiveness of ultrasound-guided thermal radiofrequency applied to the musculocutaneous nerve in adult patients with focal elbow flexor spasticity secondary to central nervous system injury. Hypothesis: Thermal radiofrequency treatment of the musculocutaneous nerve in patients with spasticity resulting from damage to the central nervous system is a safe and effective treatment for spasticity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Age 18 years or older.
- •Diagnosis of spasticity secondary to central nervous system injury.
- •Predominant elbow flexor spastic pattern dependent on the musculocutaneous nerve.
- •Patients with severe spasticity refractory to conservative treatments who underwent thermal radiofrequency treatment of the musculocutaneous nerve during the study period.
排除标准
- •No signed informed consent.
- •Age under 18 years.
- •Radiofrequency treatment applied to patients without central nervous system injury.
- •Absence of follow-up after radiofrequency treatment, for any reason, for a minimum period of 2 months.
研究组 & 干预措施
Thermal Radiofrequency of the Musculocutaneous Nerve for the Treatment of Spasticity
干预措施: Radiofrequency (Device)
结局指标
主要结局
Goniometry
时间窗: Baseline, 2 months, and 6 months after treatment
Passive elbow range of motion assessed by goniometry. Maximum passive elbow extension is measured in degrees using a standard goniometer. Values range from -160°, indicating complete elbow flexion, to 0°, indicating complete elbow extension. Higher values (closer to 0°) indicate greater passive elbow extension and a better outcome, whereas more negative values indicate a worse outcome.
Modified Ashworth Scale
时间窗: Baseline, 2 months, and 6 months after treatment
Elbow flexor muscle tone is assessed using the Modified Ashworth Scale, a 6-category ordinal scale with scores of 0, 1, 1+, 2, 3, and 4. The minimum score is 0, indicating no increase in muscle tone, and the maximum score is 4, indicating that the affected limb is rigid in flexion or extension. Higher scores indicate greater muscle tone and a worse outcome.
次要结局
- Visual Analogue Scale(Baseline, 2 months, and 6 months after treatment)
- Goal Attaintment Scaling(2 months, and 6 months after treatment.)
- Spasticity-related Quality Of Life 6-Dimensions (SQoL-6D)(Baseline, 2 months, and 6 months after treatment.)
- Physician Global Assessment (PGA)(Baseline, 2 months, and 6 months after treatment.)
- Patient Global Impression of Change (PGI-C)(Baseline, 2 months, and 6 months after treatment)
- Visual Analog Scale(Baseline, 2 months, and 6 months after treatment)
研究者
Sergio Otero Villaverde
Medical Doctor in Physical and Rehabilitation Medicine
Fundación Pública Galega de Investigación Biomédica INIBIC