NCT02038205已完成不适用
High Resolution Ultrasonographic Measurements of the Median Nerve Before and After Wrist Splinting for Carpal Tunnel Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- Cross sectional area of median nerve using ultrasound
研究概览
简要总结
A prospective cohort follow-up study design is undertaken. Both males and females with mild to moderate carpal tunnel syndrome will receive standard-of-care wrist splint for 6 weeks and undergo follow up studies for data collection. Controls will also be seen for a one time visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older and;
- •Diagnosis of mild to moderate CTS with median motor latency at 8 cm is greater than 4.5 milliseconds or Combined Sensory Index > 0.9 where first line therapy is indicated to include nocturnal wrist bracing
- •Control subjects without symptoms of carpal tunnel syndrome.
排除标准
- •Evidence of severe CTS as seen with electromyographic changes in the body of the muscle
- •Untreated hypothyroidism, Rheumatologic disorders
- •Diagnosed Severe CTS or Chronic symptoms of carpal tunnel, greater than 1 year, this includes wasting of the hand muscles
- •Undergoing or previously treated for carpal tunnel on affected side. This includes surgery (carpal tunnel release), corticosteroid injections, bracing within the last 3 months while wearing the brace consistently every night, or any other intervention.
- •Currently pregnant or < 3 months post partum
- •History of wrist, hand fracture or severe trauma to affected hand and/or wrist
- •Known tumor, mass or deformity of the hand/wrist
- •Inflammatory articular disease of the joints or tendons Existing cervical radiculopathy or previous surgeries to the neck for radicular symptoms
- •History of electrodiagnostic evidence of generalized polyneuropathy or evidence of denervation
- •Diagnosed neuromuscular disorders which may complicate CTS diagnosis
- •Implanted electronic device (pacemaker, intrathecal pump/stimulator)
- •Any illness that makes it unsafe for the patient to participate in the study
- •Not fluent in English as NeuroQOL and other subjective information is limited to the English language interpretation
结局指标
主要结局
Cross sectional area of median nerve using ultrasound
时间窗: 6 weeks
次要结局
- Patient-reported outcome measures using NeuroQOL and CTSAQ(6 weeks)
- Motor latency, motor amplitude, sensory velocity and sensory amplitude with electrodiagnostic study(6 weeks)
- cross sectional area, electrodiagnostic study, age, gender, height, weight, BMI, wrist circumference, wrist width. smoking and handedness as predictors of improvement (or no improvement) in the NeuroQOL and CTSAQ-measured clinical severity scale.(6 weeks)
研究者
研究点 (1)
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