Evaluation of Ecography as a Diagnostic Tool in the Carpal Tunnel Syndrome Compared to the Studies of Electroconduction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 438
- 试验地点
- 1
- 主要终点
- Demographic variables
研究概览
简要总结
The main objective is to investigate the value of ultrasound in the diagnosis of Carpal Tunnel Syndrome (CTS), and among the secondary objectives, to establish the ultrasound parameters that are predictors of CTS in comparison with neurophysiological studies, attempting to standardize a protocol and reference values that determine the presence or absence of CTS. Finally, cost-effectiveness analysis is proposed.
详细描述
The reference test with which the ultrasound is compared is the neurophysiological test (NPT).
The expected timeline for the study is to be performed between July 2020 and May 2023.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting clinical symptoms suggestive of CTS, at least one of the following:
- •Neuropathic profile pain in wrist-hand at the level of the median nerve territory (wrist, first-second-third, and radial half of the fourth finger by palmar and/or volar side), possibility of irradiation of the pain towards the forearm and/or arm.
- •Nocturnal symptoms.
- •Hypotrophy or atrophy of the thenar eminence.
- •Self-described sensory alteration (sensation of cramping, numbness, tingling, hypoalgesia or analgesia).
- •Age: 18 to 75 years.
- •Consent to participate in the study.
排除标准
- •Previous surgery on the wrist
- •Acquired or hereditary pathology causing peripheral neuropathies
- •Polyneuropathy of any etiology
- •Rheumatoid arthritis
- •Diabetes Mellitus
结局指标
主要结局
Demographic variables
时间窗: January 2021 to September 2022
Sex, age, time of evolution of the clinic, manual dominance, hand affected, body mass index, employment status, type of work (pink, white or blue collar), time worked, triggers of symptoms, what symptoms are relieved with, as well as toxic habits, whether they are smokers (to be answered affirmative or negative) or alcohol consumers (to be answered affirmative or negative).
Electrodiagnostic variables
时间窗: January 2021 to September 2022
Motor conduction velocity of the median nerve (calculating distal motor latency and wrist-elbow motor conduction velocity), motor conduction velocity of the ulnar nerve (calculating distal motor latency, lower and upper wrist-elbow motor conduction velocity), orthodromic sensory conduction of the median, ulnar and radial nerve, as well as antidromic sensory conduction of the median, ulnar and radial nerve.
Ultrasound variables
时间窗: January 2021 to September 2022
The cross-sectional area (CSA), range of median nerve thinning, wrist-forearm index, flexor retinaculum bulge, power Doppler uptake, and existence of notches
Cost evaluation
时间窗: From September 2022 to May 2023
Costs of the consumables established by the Andalusian Health Service used in both tests and the average time for each of the tests
Boston Carpal Tunnel Questionnaire
时间窗: January 2021 to September 2022
次要结局
未报告次要终点