The Effect and Safety of Recombinant Human Fibroblast Growth Factor-1 for Patient With Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change from baseline of severity of symptoms and functional status on 1st month, 2nd month, 3rd month,4th month, 6th month after injection.
研究概览
简要总结
Carpal tunnel syndrome (CTS) is a common peripheral entrapment mononeuropathy of the upper limb, which results from compression of median nerve at level of wrist. In recent years, regenerative medicine has gradually been applied in the treatment of various degenerative conditions such as bones, muscles, and nerves. Human fibroblast growth factor 1 is a single-chain protein , which has been shown to play a crucial regulatory role in the brain and spinal cord and can facilitate nerve cell differentiation and growth. ES135 is a recombinant human fibroblast growth factor 1 (rhFGF1) which is composed of 135 amino acids with a molecular weight of approximately 15.2 kilodalton. Several studies have shown that significant improvement of Functional Independence Measure, motor and sensory function of spinal cord injury patients after ES135 treatment. One study also revealed the muscle strength have significant improvement in brachial plexus injury patients after ES135 therapy. According to above studies, the investigators hypothesized that ES135 may have benefits to CTS patients. Hence, the purpose of this study aim to demonstrate the therapeutic effects and safety of ES135 for CTS.
详细描述
Participants established with diagnosis of mild-to-moderate CTS will been randomly assigned to ES135 or Placebo groups. With ultrasound guidance, injection with ES135 or Placebo was performed between median nerve and transcarpal ligament. The Boston Carpal Tunnel Syndrome Questionnaire is assigned as primary outcome. The secondary outcomes encompass visual analog scale, electrophysiological studies and cross-sectional area of the median nerve. The assessment is performed prior injection and at 1, 2, 3, 4 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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-80 year-old.
- •Diagnosis was confirmed by using an electrophysiological study
- •CTS symptoms for more than 3 months.
排除标准
- •Severe CTS
- •Allergy to ES135
- •Pregnancy
- •Inflammation status
- •Cervical radiculopathy
- •Polyneuropathy, brachial plexopathy
- •Thoracic outlet syndrome
- •Previously undergone wrist surgery or steroid/platelet-rich plasma injection for CTS within 12 months
研究组 & 干预措施
recombinant human fibroblast growth factor 1 (ES135)
Ultrasound-guided injection with recombinant human fibroblast growth factor 1 (ES135) between carpal tunnel and median nerve.
干预措施: Sono-guided injection with ES135 (Procedure)
normal saline
Ultrasound-guided injection with normal saline between carpal tunnel and median nerve.
干预措施: Sono-guided injection with placebo (Procedure)
结局指标
主要结局
Change from baseline of severity of symptoms and functional status on 1st month, 2nd month, 3rd month,4th month, 6th month after injection.
时间窗: Pre-treatment, 1st month, 2nd month, 3rd month,4th month, 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 cross-sectional area of the median nerve on 1st month, 2nd month, 3rd month,4th month, 6th month after injection.(Pre-treatment, 1st month, 2nd month, 3rd month,4th month, 6th month.)
- Change from baseline of pain on 1st month, 2nd month, 3rd month,4th month, 6th month after injection.(Pre-treatment, 1st month, 2nd month, 3rd month,4th month, 6th month.)
- Change from baseline of conduction velocity, latency of median nerve on 1st month, 2nd month, 3rd month,4th month, 6th month.(Pre-treatment, 1st month, 2nd month, 3rd month,4th month, 6th month.)
研究者
Yu-CHI Su
Attending Physician and lecturer of Department of Physical Medicine and Rehabilitation
Tri-Service General Hospital