Syndrome du Tunnel Carpien - Essai Clinique randomisé évaluant l'efficacité de l'Utilisation de l'échographie Lors de l'Infiltration de corticostéroïdes
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale
研究概览
简要总结
The objective of this study is to evaluate the efficacy of ultrasound guided corticosteroid injection in reducing symptoms caused by carpal tunnel syndrome.
详细描述
Corticosteroid injection is routinely given for treating carpal tunnel syndrome. The objective of this study is to evaluate the efficacy of ultrasound guided corticosteroid injection in reducing symptoms caused by carpal tunnel syndrome.
In this randomised clinical trial, 50 patients with both a clinical and electromyographic diagnosis of mild to moderate carpal tunnel syndrome will be recruited from the Centre Hospitalier Universitaire de Sherbrooke (CHUS). Subjects will be randomised to ultrasound guided or blind injection groups. All subjects will receive 40 mg of methylprednisolone. The primary outcome will be the Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale at baseline and 3 months post injection. Both subjects and assessors will be blinded.
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
- Triple (Participant, Investigator, 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 to 65
- •Understanding written and spoken french
- •Diagnostic of carpal tunnel syndrome : Classic of probable based on the Katz Hand Diagram and mild to moderate based on the electrodiagnosis studies
排除标准
- •Carpal tunnel injection in the last 6 months
- •Constant symptoms in medial nerve area
- •Thenar eminence atrophy
- •Absolute contraindication to corticosteroid injection : infective arthritis, bacterial endocarditis, local cellulitis of skin infection, coagulopathy, corticosteroid or latex allergy
- •Secondary diagnosis based on the ultrasound : arthrosynovial cyst, flexor tenosynovitis, ganglion
- •Known cognitive disorder
- •Anticoagulant therapy
- •Diseases known to cause carpal tunnel syndrome : Diabetes mellitus, hypothyroidism, connective tissue disease, rheumatic disease and moderate or severe chronic renal impairment
- •Radiculopathy
- •Polyneuropathy
- •Pregnancy
- •Ancient ipsilateral wrist fracture
- •Ancient ipsilateral wrist surgery
研究组 & 干预措施
Ultrasound guided injection
Ultrasound guided injection of 40 mg of methylprednisolone
干预措施: Ultrasound (Device)
Ultrasound guided injection
Ultrasound guided injection of 40 mg of methylprednisolone
干预措施: methylprednisolone (Drug)
Blind injection
Blind injection of 40 mg of methylprednisolone
干预措施: methylprednisolone (Drug)
结局指标
主要结局
Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale
时间窗: 3 months
The Boston Questionnaire is self-applied by the patient. It has a symptom severity scale and a functional status scale.
次要结局
- DASH questionnaire(3 months)
- Ultrasound measured medial nerve area in carpal tunnel(3 months)
- Boston Carpal Tunnel Syndrome Questionnaire - Functional Status Scale(3 months)
- Numeric Pain Rating Scale(Baseline)
- Ultrasound measured medial nerve area difference between pronator quadratus and carpal tunnel(3 months)
- Ultrasound hypervascularisation of medial nerve in carpal tunnel(3 months)
- Global Rating of Change(3 months)
研究者
Alessandra Bruns
MD, FRCPC
Université de Sherbrooke