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Recruiting Not applicable NCT07324005

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

No applicable phase (e.g. observational)
Conditions: Carpal Tunnel Syndrome Dextrose Carpal Tunnel Release Ultrasound Nerve Hydrodissection Therapy

Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

trial.available_in: БГ
Overview
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.
Description
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 n
Who can participate
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Interventions
Active Comparator: US-guided D5W perineural hydrodissection alone, group A
PROCEDURE
Active Comparator: US guided partial release of the TCL with a needle + D5W injection (to TCL), group B
PROCEDURE
Active Comparator: US-guided partial release of the TCL with D5W injection to TCL plus D5W perineural hydrodissection, group C
PROCEDURE
Locations 1
Taiwan (1)
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
20 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
01.01.2026
Completion date
31.12.2030
Registry ID
NCT07324005
Source
clinicaltrials.gov
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