A Comparative Analysis of the Efficacy of Ultrasound-Guided Injection of 5% Dextrose in Water for the Treatment of Mild to Severe Carpal Tunnel Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale(VAS)
研究概览
简要总结
This study was a prospective randomized double-blind clinical trial conducted at the Physical Medicine and Rehabilitation Clinic of a local research and training hospital in Turkey from October 2023 and May 2024. Patients diagnosed with CTS were classified into three groups: severe, mild, and moderate CTS, based on the results of electrophysiological tests. An ultrasound-guided 5% Dextrose in Water injection was performed. The primary outcome measurement was the Visual Analog Scale (VAS), while secondary measurements were the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the Dolour Neuropathic en 4 Questions (DN4) questionnaire. The measurements were performed before the injection and at the first week, first month and third month follow-up times. The distribution of data within groups was examined using the Shapiro-Wilk test and Q-Q plots. The study also analyzed temporal changes, group differences, and intergroup changes using repeated measures ANOVA models.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paresthesia/dysesthesia, painful swelling with clumsy weakness of the hand exacerbated by sleep or repetitive use of the wrist, and relieved by shaking the hand with postural change.
- •Sensory loss with numbness in the median nerve-innervated regions of the hand.
- •Weakness with atrophy of the median nerve-innervated thenar muscles.
- •Positive Phalen's test and/or Tinel's sign.
- •The diagnosis should be confirmed with electrodiagnostic studies.
排除标准
- •History of cervical myelomalacia, polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
- •History of systematic infection, and rheumatologic disorders.
- •Previous steroid injection for carpal tunnel syndrome.
研究组 & 干预措施
Group 1
Mild Carpal Tunnel syndrome
干预措施: Carpal Tunnel Hydrodissection with %5 dextrose in water injection (Drug)
Group 2
Moderate Carpal Tunnel Syndrome
干预措施: Carpal Tunnel Hydrodissection with %5 dextrose in water injection (Drug)
Group 3
Severe Carpal Tunnel Syndrome
干预措施: Carpal Tunnel Hydrodissection with %5 dextrose in water injection (Drug)
结局指标
主要结局
Visual Analogue Scale(VAS)
时间窗: At the beginning, 1.,4., 12. week
VAS is comprised of a horizontal line of 10 cm in length. A measurement of 0 cm indicates the absence of pain, whereas a measurement of 10 cm signifies the most severe pain that one can conceive. Patients are instructed to assess the intensity of discomfort by indicating a point on this line. The Turkish version of the assessment has been validated and shown to be reliable.
次要结局
- Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)(At the beginning, 1.,4., 12. week)
- Dolour Neuropathique en 4 Questions (DN4) questionnaire(At the beginning, 1.,4., 12. week)
研究者
Gamze Gul Gulec
Assistant Proffesor
Kastamonu University