Sonography-guided Steroid Injection for Carpal Tunnel Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 主要终点
- QuickDASH
研究概览
简要总结
Purpose: To compare the outcome between sonography-guided steroid injection and direct steroid injection on carpal tunnel syndrome(CTS).
详细描述
Material and methods
We have enrolled 26 ideopathic carpal tunnel syndrome patients (minimal to moderate according to Padua's classification).Thirteen patients were allocated in sonography approach group( sonography-guided local wrist injection, SAG) and the 13 patients were placed in direct approach group(direct local injection without using sonography, DAG). One , 3 and 6 months later after injection, we performed the outcome measures, including Boston symptom and functional scale, QuickDASH, nerve conduction study and sonography. If the patients receive the second injections, we will follow their treatment outcome by phone regularly at 1,3 and 6 months after first injection. If the patients were referred to surgery, the failures of local injection were considered and we will stop follow up them. After performing all assessment, we will compare the outcomes between the two groups.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with >2 following symptoms :
- •disrupt sleep result in nocturnal paresthesia.
- •symptoms release by shaking hand.
- •pain and paresthesia during grasping.
- •any sensory symptom on first, 2th, 3th and partial 4th fingers.
- •symptoms >1month.
- •Padua's classification : minimal, mild, moderate)
- •meet one of three diagnosis criteria of carpal tunnel syndrome.
排除标准
- •any history can cause periphery nerve disease.
- •affected side had fracture or paralysis.
- •had accepted operation for carpal tunnel syndrome before.
- •wrist or hand sprain, ulnar nerve disease cervical nerve root disease, multiple neuropathy or nerve anastomosis.
- •Padua's classification: severe, extreme.
- •ultrasonography show space occupying.
- •patient taking anticoagulants.
- •severe systemic disease.
- •wrist's skin or wrist joint has infection.
- •can't complete the 6 months' follow up.
- •allergy to steroid.
- •has cognition disorder.
研究组 & 干预措施
Inject betamethasone by sonography
Use 5/8 in medical needles inject betamethasone 7mg (1ml) in distal wrist crease by sonography- guided. Entering skin with 30 degrees from the ulnar side of palmaris longus tandon. Changing direction of injection to prevent median nerve injury if patients feel numbness or pain in hand.
干预措施: betamethasone (Drug)
Inject betamethasone directly
Use 5/8 in medical needles inject betamethasone 7mg (1ml) in distal wrist crease directly. Entering skin with 30 degrees from the ulnar side of palmaris longus tandon. Changing direction of injection to prevent median nerve injury if patients feel numbness or pain in hand.
干预措施: betamethasone (Drug)
结局指标
主要结局
QuickDASH
时间窗: Change from Baseline data at 6 weeks
次要结局
- 2-Point Discrimination test on 2nd digit(Change from Baseline data at 6 weeks)
- Nerve conduction study done on the affected hand using Necolet Viking Quest(Change from Baseline data at 6 weeks)
- Sonography examination done with patients sitting, elbow flexion and forearm supination placing on table(Change from Baseline data at 6 weeks)
- Chinese version of Boston symptom and function scale for carpal tunnel syndrome, SS & FS(Change from Baseline data at 6 weeks)
- Record the neurological symptoms perceived by patient after injection according to their describtion(Change from Baseline data at 6 weeks)
- Semmes-Weinstein Monofilament test(SWMT)(Change from Baseline data at 6 weeks)