The Effect of Different Molecular Weight of Hyaluronic Acid for Patients With Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month after injection
研究概览
简要总结
Recently, nerve hydrodissection is utilized to assist ultrasound-guided nerve injection and studies recommend its clinical benefit for peripheral entrapment neuropathy. Hyaluronic acid (HA) can decrease the post-surgery adhesion of soft tissue and nerve but its clinical application in clinical practice is very rare.
We just proved that single HA injection have short-term effectiveness in mild-to-moderate carpal tunnel (CTS) cases and this finding may hint the therapeutic effectiveness of nerve hydrodissection for CTS depend on absorption time of solution. In addition, no study compare different weight of HA for nerve injection so far. Hence, the purpose of this study aim to compare different weight of HA for CTS and whether hydrodissection effect depend on the absorption time of solution or not.
详细描述
Participants established with diagnosis of mild-to-moderate CTS will been randomly assigned to high molecular weight HA (Aragan Plus, 20 mg/2 ml, 3000kDa) or low molecular weight HA (ARTZDispo, 25 mg/2.5 ml, 600-1200kDa) groups. With ultrasound guidance, total two-sessions of high or low molecular weight HA with one week interval will been injected into intra-carpal region. The Boston Carpal Tunnel Syndrome Questionnaire is assigned as primary outcome. The secondary outcomes encompass visual analog scale, electrophysiological studies, cross-sectional area of the median nerve, mobility of median nerve and absorption time of HA. The assessment is performed prior injection and at 2 week, 1, 2, 3 and 6 months post-injection.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20-80 year-old.
- •Diagnosis was confirmed using an electrophysiological study
排除标准
- •Coagulopathy
- •Pregnancy
- •Inflammation status
- •Cervical radiculopathy
- •Polyneuropathy, brachial plexopathy
- •Thoracic outlet syndrome
- •Previously undergone wrist surgery or steroid injection for CTS
结局指标
主要结局
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month after injection
时间窗: Pre-treatment, 2nd week, 1st, 3rd, 6th month
Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.
次要结局
- Change from baseline of pain on 2nd week, 1st, 3rd, 6th month after injection(Pre-treatment, 2nd week, 1st, 3rd, 6th month)
- Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month after injection(Pre-treatment, 2nd week, 1st, 3rd, 6th month)
- Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month after injection(Pre-treatment, 2nd week, 1st, 3rd, 6th month)
- Change from baseline of mobility of median nerve on 2nd week, 1st, 3rd, 6th month after injection(Pre-treatment, 2nd week, 1st, 3rd, 6th month)
研究者
Yung-Tsan Wu
Attending Physician and associated professor of Department of Physical Medicine and Rehabilitation
Tri-Service General Hospital