Combined Effect of Insulin and Sodium Hyaluronate Injection Guided by Ultrasound in Carpal Tunnel Syndrome
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 90
- 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
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. The technique of perineural injection therapy (PIT) is now commonly used for peeling the nerve from surrounding soft tissue (called nerve hydrodissection), which may help to reduce neuro-inflammation, ischemic damage and allow impulse transmission.
The objective of this study is to evaluate the efficacy of ultrasound guided insulin plus Sodium Hyaluronate injection in reducing symptoms caused by carpal tunnel syndrome.
详细描述
In this randomized clinical trial, 90 patients with both a clinical and electromyographic diagnosis of mild to moderate carpal tunnel syndrome will be recruited from Assiut University Hospital (AUH). After obtaining written informed consent, patients will be randomized into three groups. Group A, patients will receive ultrasound-guided PIT with 10 IU of crystalline insulin; Group B, patients will receive ultrasound-guided PIT with 20 mg of Sodium Hyaluronate; Group C, patients will receive ultrasound-guided PIT with 10 IU of crystalline insulin and 20 mg of Sodium Hyaluronate. The primary outcome will be the Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale at baseline, 1 month and 3 months post injection. All participants, investigator, outcomes assessor will be blinded (Triple blind)
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 Arabic consent
- •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
- •Diseases known to cause carpal tunnel syndrome: Diabetes mellitus, hypothyroidism, connective tissue disease, rheumatic disease and moderate or severe chronic renal impairment
- •Secondary diagnosis based on the ultrasound: arthrosynovial cyst, flexor tenosynovitis, ganglion
- •Constant symptoms in medial nerve area
- •Thenar eminence atrophy
- •Cervical radiculopathy
- •Brachial plexopathy
- •Thoracic outlet syndrome
- •Polyneuropathy
- •Pregnancy
- •Cognitive disorder
- •Anticoagulant therapy
- •Carpal tunnel injection in the last 6 months
- •Ancient ipsilateral wrist fracture
- •Ancient ipsilateral wrist surgery
研究组 & 干预措施
Insulin and Sodium Hyaluronate Ultrasound guided injection
Subjects will receive Ultrasound guided injection of 10 IU of crystalline insulin and 20 mg of Sodium Hyaluronate
干预措施: Insulin (Drug)
Insulin and Sodium Hyaluronate Ultrasound guided injection
Subjects will receive Ultrasound guided injection of 10 IU of crystalline insulin and 20 mg of Sodium Hyaluronate
干预措施: Sodium Hyaluronate (Drug)
Insulin and Sodium Hyaluronate Ultrasound guided injection
Subjects will receive Ultrasound guided injection of 10 IU of crystalline insulin and 20 mg of Sodium Hyaluronate
干预措施: Ultrasound (Device)
Insulin Ultrasound guided injection
Subjects will receive Ultrasound guided injection of 10 IU of crystalline insulin
干预措施: Insulin (Drug)
Insulin Ultrasound guided injection
Subjects will receive Ultrasound guided injection of 10 IU of crystalline insulin
干预措施: Ultrasound (Device)
Sodium Hyaluronate Ultrasound guided injection
Subjects will receive Ultrasound guided injection of 20 mg of Sodium Hyaluronate
干预措施: Sodium Hyaluronate (Drug)
Sodium Hyaluronate Ultrasound guided injection
Subjects will receive Ultrasound guided injection of 20 mg of Sodium Hyaluronate
干预措施: Ultrasound (Device)
结局指标
主要结局
Boston Carpal Tunnel Syndrome Questionnaire - Symptom Severity Scale
时间窗: Baseline, 1 month, 3 months
Boston carpal tunnel syndrome questionnaire - SSS is patient-based questionnaire for measurement of CTS severity which include11 questions to evaluate the symptom severity. Each question ranges from 1 to 5 with a higher score indicating a higher degree of disability.
次要结局
- Boston Carpal Tunnel Syndrome Questionnaire - Functional Status Scale(Baseline, 1 month, 3 months)
- Neuropathic pain Visual Analog Scale (VAS)(Baseline, 1 month, 3 months)
- U/S measured medial nerve mean CSA(Baseline, 1 month, 3 months)
- U/S measured medial nerve CSA difference(Baseline, 1 month, 3 months)
- U/S hyper-vascularization of medial nerve percentage(Baseline, 1 month, 3 months)
- Sensory nerve conduction velocity of the median nerve(Baseline, 1 month, 3 months)
研究者
Khaled Osama Aboshaera
Assistant Professor
Assiut University