Comparison of Corticosteroid and Repeated Dextrose Hydro-dissection for Carpal Tunnel Syndrome Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Boston Carpal Tunnel Syndrome Questionnaire
研究概览
简要总结
Carpal tunnel syndrome (CTS) is the most prevalent peripheral nerve entrapment of upper limb. Typical symptoms comprise pain, numbness or tingling of the thumb and index, middle or ring fingers. Thumb weakness and decreased grip strength can occur in the later stage. Currently treatments included physical modalities (low power laser, transcutaneous electrical nerve stimulation, ultrasound), medication, splinting, injection and surgery. Ultrasound guided intracarpal hydro-dissection of median nerve had been proposed based on its accurate localization, while the injectates were diverse. Corticosteroid has been widely used for CTS for decades. However, growing evidences suggested that 5% dextrose, normal saline, platelet rich plasma injection also have therapeutic effects on alleviating CTS symptoms. Among the injectates, a single 5% dextrose injection could be considered as a substitute of corticosteroid based on its long term effect up to six months. However, the clinical efficacy of 5% dextrose injection has not validated by the further study. The investigators aim to compare the therapeutic effect of 5% dextrose injection with corticosteroid injection in patients with CTS, up to 12 weeks follow up.
详细描述
Introduction:
Carpal tunnel syndrome (CTS) is the most prevalent peripheral nerve entrapment of upper limb. Typical symptoms comprise pain, numbness or tingling of the thumb and index, middle or ring fingers. Thumb weakness and decreased grip strength can occur in the later stage. Currently treatments included physical modalities (low power laser, transcutaneous electrical nerve stimulation, ultrasound), medication, splinting, injection and surgery. Ultrasound guided intracarpal hydro-dissection of median nerve had been proposed based on its accurate localization, while the injectates were diverse. Corticosteroid has been widely used for CTS for decades. However, growing evidences suggested that 5% dextrose, normal saline, platelet rich plasma injection also have therapeutic effects on alleviating CTS symptoms. Among the injectates, a single 5% dextrose injection could be considered as a substitute of corticosteroid based on its long term effect up to six months. However, the clinical efficacy of 5% dextrose injection has not validated by the further study. Whether repeated injection could expand the treatment effect was undetermined. The investigators aim to compare the therapeutic effect repeated 5% dextrose injection with corticosteroid injection in patients with CTS, up to 12 weeks follow up.
Material and methods:
Participants: 60 adult patients (>20 year olds) with carpal tunnel syndrome, recruited from outpatient clinic.
Inclusion criteria: Presenting with CTS symptoms, including nocturnal, postural, or motion-associated paresthesias +/- pain of the median nerve distribution area in the subjective hand. Confirmed Electrophysiological confirmed median neuropathy at the wrist with mild to moderate degree. Persistent symptoms for more than 3 months
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting with carpal tunnel syndrome symptoms, including nocturnal, postural, or motion-associated paresthesias +/- pain of the median nerve distribution area in the subjective hand
- •Confirmed Electrophysiological confirmed median neuropathy at the wrist with mild to moderate degree
- •Persistent symptoms for more than 3 months
排除标准
- •Patients with suspicious of CTS mimic condition, including cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome
- •Recent corticosteroid injection to the carpal tunnel within 6 months
- •Thenar muscle atrophy
- •Previous history of carpal tunnel surgical release
- •History of wrist trauma
- •Regular use of systemic nonsteroidal anti-inflammatory drugs, corticosteroids or diuretics
- •Pregnancy
- •Cognitive impairment
研究组 & 干预措施
Ultrasound intracarpal corticosteroid injection
Twice ultrasound-guided hydro-dissection of median nerve at carpal tunnel level.
1st injection (0 week): 40mg triamcinolone acetonide (40mg/mL ) with 4mL normal saline, 2nd injection (6 week): 5 mL normal saline
干预措施: Triamcinolone Acetonide (Drug)
Ultrasound guided intracarpal dextrose hydro-dissection
Twice ultrasound-guided hydro-dissection of median nerve at carpal tunnel level.
Group B: 1st injection (0 week): 5 mL 5% dextrose, 2nd injection (6 week): 5 mL 5% dextrose
干预措施: Dextrose 5% in water (Drug)
结局指标
主要结局
Boston Carpal Tunnel Syndrome Questionnaire
时间窗: Change of the score between 6 weeks and baseline(1st injection), and change of the score between 12 weeks and baseline (1st injection))
Evaluation of symptom severity (11-question) and functional impairment (8-question) subscale. The scores range from 0 to 5 points for each question, with higher scores indicating greater severity and dysfunction.
次要结局
- Cross-sectional area of median nerve (unit: mm2)(Change of the score between 6 weeks and baseline(1st injection), and change of the score between 12 weeks and baseline (1st injection)))
- Amplitude of median nerve sensory nerve action potential (Unit: μV)(change of the score between 12 weeks and baseline (1st injection))
- Amplitude of median nerve compound motor action potential (Unit: mV)(change of the score between 12 weeks and baseline (1st injection))
- Global assessment of treatment (1st)(6-week after 1st injection (before 2nd injection))
- Visual analogue scale(Change of the score between 6 weeks and baseline(1st injection), and change of the score between 12 weeks and baseline (1st injection)))
- Distal latency of median nerve sensory nerve action potential (Unit: ms)(change of the score between 12 weeks and baseline (1st injection))
- Distal latency of median nerve compound motor action potential (Unit: ms)(change of the score between 12 weeks and baseline (1st injection))
- Global assessment of treatment (2nd)(6-week after 2nd injection (12-week after 1st injection))