Ultrasound-Guided Percutaneous Electrical Nerve Stimulation of the Median Nerve for Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Changes in pain intensity between baseline and follow-up periods
研究概览
简要总结
There is evidence supporting that physical therapy interventions can be effective for the management of patients with CTS. No consensus on the best approach exist. It seems clear that the median nerve is affected in several ways (compression, inflammation, excursion) in carpal tunnel syndrome. Percutaneous Electrical Nerve Stimulation is a treatment approach consisting of the application of an electrical current throughout needling filaments placed close to the nerve, in this case the median nerve. The purpose of this clinical trial is to compare changes in function, symptom severity and the intensity of pain after the application of Percutaneous Electrical Nerve Stimulation vs. endoscopic surgery in women with CTS at short- and long-term follow-up periods.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pain and paresthesia in the median nerve distribution
- •positive Tinel sign,
- •positive Phalen sign,
- •symptoms had to have persisted for at least 6 months
- •deficits of sensory and motor median nerve conduction according to guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Physical Medicine and Rehabilitation Academy
排除标准
- •any sensory/motor deficit related to the ulnar or radial nerve;
- •older than 65 years of age;
- •previous surgical intervention, steroid injections or physical therapy intervention
- •multiple diagnoses of the upper extremity (eg, cervical radiculopathy);
- •history of neck, shoulder, or upper limb trauma (whiplash);
- •history of any systemic disease causing CTS (eg, diabetes mellitus, thyroid disease);
- •history of other systemic conditions (eg, rheumatoid arthritis, fibromyalgia);
- •pregnancy;
结局指标
主要结局
Changes in pain intensity between baseline and follow-up periods
时间窗: Baseline and 1, 3, 6 and 12 months after the intervention.
An 11-point Numerical Pain Rating Scale (NPRS, 0: no pain - 10: maximum pain) will be used to assess the patients' current level of hand pain and the worst and lowest level of pain experienced in the preceding week.
次要结局
- Changes in hand function between baseline and follow-up periods(Baseline and 1, 3, 6 and 12 months after the intervention.)
- Changes in patient self-perceived improvement between baseline and follow-up periods(Baseline and 1, 3, 6 and 12 months after the intervention.)
- Changes in severity between baseline and follow-up periods(Baseline and 1, 3, 6 and 12 months after the intervention.)
研究者
César Fernández-de-las-Peñas
Full proffessor
Universidad Rey Juan Carlos