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临床试验/NCT07324005
NCT07324005
尚未招募
不适用

Efficacy of Combining Ultrasound-Guided Needle Release of Transverse Carpal Ligament and Median Nerve Dextrose Water Hydrodissection for Carpal Tunnel Syndrome

Shin Kong Wu Ho-Su Memorial Hospital1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2026年1月1日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
102
试验地点
1
主要终点
The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)

概览

简要总结

Carpal tunnel syndrome (CTS) is a common musculoskeletal disorder, which is caused by compression of the median nerve as it travels through the wrist. There are several treatments for CTS, including conservative and surgical options. Though local corticosteroid injection has been considered more effective than physical therapy for treatment of CTS and has significant short-term benefits, long term benefits are not evidenced. Several studies in recent years reported significantly superior longer-term benefit of D5W and PRP compared with corticosteroid injections and other conservative managements. In addition, percutaneous release of the transverse carpal ligament (TCL) was developed to treat CTS in recent years. Because the effectiveness of the recently developed techniques in treating CTS has not been well established, the investigators aim to investigate whether combining US-guided partial release of the transverse carpal ligament with a needle plus D5W hydrodissection is more beneficial for CTS comparing to either treatment alone.

详细描述

Carpal tunnel syndrome (CTS) is a common musculoskeletal disorder, which is caused by compression of the median nerve as it travels through the wrist. The prevalence of CTS ranges from 3% to 7.43%, and it carries a significant economic burden, influencing the number of workdays lost. Risk factors for CTS include occupations that need repetitive hand movements, female gender, age, pregnancy, obesity, diabetes, and specific anatomical and physiological traits. The symptoms and signs of CTS include tingling, numbness, nocturnal paresthesia, and pain in the median nerve distribution, whereas thenar atrophy and weakness of grasping manifest in the late stages. The widely-accepted pathophysiology includes increased pressure in the carpal tunnel, median nerve microcirculation injury, synovial tissue hypertrophy, and connective tissue compression of the median nerve. The interactions of mechanisms can lead to venous outflow obstruction, edema, and then ischemia and nerve injury ultimately. The diagnosis of CTS is made via the patient's history and physical examination, and electrodiagnostic tests may be done to differentiate among diagnoses. In recent years ultrasonographic image study of the median nerve can be applied in the evaluation and/or diagnosis of CTS. There are several treatments for CTS, including conservative and surgical options. For mild to moderate CTS, non-surgical treatments such as splinting, physical therapy, ultrasound (US)-guided corticosteroid injection, oral medications, and manual therapies are recommended. Although a systemic review showed that surgical approach yield better midterm and long term outcomes than conservative managements, there are some complications of open carpal tunnel release, including neuroma of the palmar cutaneous branch of the median nerve, infection, hypertrophic scars, postoperative pain, and persistent or recurrent symptoms. Therefore, surgical treatment is recommended only after 7 conservative management failure, or for more severe CTS.

Though local corticosteroid injection has been considered more effective than physical therapy for treatment of CTS and has significant short term benefits, long term benefits are not evidenced. In the recent decade, ultrasound guided regenerative medicine was developed to treat CTS, among which five percent dextrose in water (D5W) and platelet-rich plasma (PRP) are two commonly used injectates. Several studies in recent years reported significantly superior longer-term benefit of D5W and PRP compared with corticosteroid injections and other conservative managements. The mechanism of regenerative medicine for CTS can be divided into pharmacological and mechanical effects. The pharmacological effect includes initiating tissue proliferation in the absence of inflammation, whereas the mechanical effect can be refer to hydrodissection. In addition, percutaneous release of the transverse carpal ligament (TCL) was developed to treat CTS in recent years.

Acupotomy, using a needle-knife derived from traditional Chinese medicine to release TCL and promote local blood circulation, is a safe and effective option when performed via ultrasound guidance. Other than using a needle-knife, partial release of TCL with a needle is another choice. In a prospective study in 2022, ultrasound guided partial release of TCL using an 18-G needle was done in patients with CTS, and the result revealed that 86.2% wrists showed successful treatment outcomes at 6 months after intervention. Another cohort study in 2024 showed that treating severe CTS with ultrasound-guided partial release of TCL using a 21-G curved needle resulted in improved outcomes at the 6-week follow-up. Because the effectiveness of the recently developed techniques in treating CTS has not been well established, the investigators aim to investigate whether combining US-guided partial release of the transverse carpal ligament with a needle plus D5W hydrodissection is more beneficial for CTS comparing to either treatment alone. The investigators hypothesize that adding percutaneous release of the TCL to D5W hydrodissection could bring more therapeutic effects.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age between 20 to 80 years old
  • diagnosed with CTS on the basis of clinical condition and an electrophysiological analysis
  • the NRS of pain or paresthesia≧3
  • with symptoms lasting for a minimum of 3 months.

排除标准

  • history of polyneuropathy, thoracic outlet syndrome, brachial plexopathy, or inflammatory arthropathy
  • onset of CTS during pregnancy, hypothyroidism, or systemic infection
  • previous corticosteroid injection or wrist surgery for CTS
  • hypersensitivity to dextrose injection
  • the anatomic structure of the wrist is not suitable for needle release of TCL.

研究组 & 干预措施

US-guided D5W perineural hydrodissection alone, group A

Active Comparator

Patients in the group A will receive 1 session of ultrasound-guided perineural injection with 5ml D5W.

干预措施: Active Comparator: US-guided D5W perineural hydrodissection alone, group A (Procedure)

US guided partial release of the TCL with a needle + D5W injection (to TCL), group B

Active Comparator

Patients in the group B will receive 1 session of ultrasound-guided partial release of the TCL with a needle plus D5W injection to TCL.

干预措施: Active Comparator: US guided partial release of the TCL with a needle + D5W injection (to TCL), group B (Procedure)

US-guided partial release of the TCL with D5W injection to TCL plus D5W perineural hydrodissection

Active Comparator

Patients in the group C will receive 1 session of the treatment combining group A and group B.

干预措施: Active Comparator: US-guided partial release of the TCL with D5W injection to TCL plus D5W perineural hydrodissection, group C (Procedure)

结局指标

主要结局

The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)

时间窗: baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.

The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a widely applied, patient

次要结局

  • Numeric rating scale (NRS)(baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.)
  • Cross-sectional area (CSA)(baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.)
  • Electrophysiological measurement(baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.)
  • Tip pinch strength(baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.)
  • Self-assessment of the treatment effect(baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lin-Fen Hsieh

Study Principal Investigator

Shin Kong Wu Ho-Su Memorial Hospital

研究点 (1)

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