Evaluation of Pain, Hand Function, Electrophysiological and Ultrasonographic Effects When Comparing 5% Dextrose Saline Injection Via Nerve Hydrodissection Under Ultrasound Guidance in Mild to Moderate Carpal Tunnel Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in pain intensity measured by Visual Analog Scale (VAS)
研究概览
简要总结
Comparison of the effectiveness of nerve hydrodissection with saline injection of 5% dextrose in carpal tunnel syndrome.
详细描述
Evaluation of pain, hand function, electrophysiological and ultrasonographic effects when comparing 5% dextrose saline injection via nerve hydrodissection under ultrasound guidance in mild to moderate carpal tunnel syndrome.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-80 years
- •Clinical and electrophysiological diagnosis of mild to moderate carpal tunnel syndrome
- •Symptom duration of at least 3 months
- •Both male and female participants
- •Patients who have not responded adequately to conservative treatment
- •Patients who do not wish to undergo surgical treatment
- •Ability to provide informed consent
排除标准
- •Severe or very severe carpal tunnel syndrome based on EMG findings
- •Previous injection therapy for carpal tunnel syndrome
- •Prior wrist or carpal tunnel surgery
- •Polyneuropathy or other peripheral neuropathies
- •Cervical radiculopathy or proximal median nerve entrapment
- •Brachial plexopathy or thoracic outlet syndrome
- •Pregnancy
- •Malignancy
- •Local or systemic infection
- •Cognitive impairment affecting cooperation
- •Systemic diseases affecting the median nerve (e.g., uncontrolled diabetes mellitus, thyroid disorders)
研究组 & 干预措施
Splint group
Patients use only a wrist splint without injection therapy
干预措施: Nerve Hydrodissection with 5% Dextrose (Drug)
5% dextrose group
Ultrasound-guided median nerve hydrodissection with 5% dextrose
干预措施: Nerve Hydrodissection with 5% Dextrose (Drug)
Saline group
Sham ultrasound-guided perineural injection with normal saline
干预措施: Nerve Hydrodissection with 5% Dextrose (Drug)
结局指标
主要结局
Change in pain intensity measured by Visual Analog Scale (VAS)
时间窗: Baseline to 8 month
The primary outcome is the change in pain intensity assessed by the Visual Analog Scale (VAS, 0-10). The difference between baseline and follow-up scores will be analyzed.
次要结局
- Change in Qucik DASH score(Baseline to 8 month)
- Change in median nerve cross-sectional area(Baseline to 8 month)
- hange in nerve conduction study parameters(Baseline to 8 month)
- Change in hand grip strength(Baseline to 8 month)