Efficacy of Combining Ultrasound-Guided Needle Release of Transverse Carpal Ligament and Median Nerve Dextrose Water Hydrodissection for Carpal Tunnel Syndrome
1 other identifier
interventional
102
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedFirst Posted
Study publicly available on registry
January 7, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
April 23, 2026
April 1, 2026
3 years
December 22, 2025
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a widely applied patient-reported tool for assessing the severity of carpal tunnel syndrome. This instrument consists of two sections: the Symptom Severity Scale (SSS), comprising 11 questions, and the Functional Status Scale (FSS), containing 8 items. Both scales use a 1 to 5 rating system. The minimum score is 19, and maximum value is 95. Higher scores mean a worse outcome.
baseline (before injection) and at follow-up intervals of 1, 3, and 6 months after the injection.
Secondary Outcomes (5)
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.
Study Arms (3)
US-guided D5W perineural hydrodissection alone, group A
ACTIVE COMPARATORPatients in the group A will receive 1 session of ultrasound-guided perineural injection with 5ml D5W.
US guided partial release of the TCL with a needle + D5W injection (to TCL), group B
ACTIVE COMPARATORPatients in the group B will receive 1 session of ultrasound-guided partial release of the TCL with a needle plus D5W injection to TCL.
US-guided partial release of the TCL with D5W injection to TCL plus D5W perineural hydrodissection
ACTIVE COMPARATORPatients in the group C will receive 1 session of the treatment combining group A and group B.
Interventions
Patients in the group A will receive 1 session of ultrasound-guided perineural injection with 5ml D5W.
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.
Patients in the group C will receive 1 session of the treatment combining group A and group B. Hydrodissection of the median nerve will be performed before TCL release.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lin-Fen Hsieh
Shin Kong Wu Ho-Su Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
December 22, 2025
First Posted
January 7, 2026
Study Start
January 1, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2030
Last Updated
April 23, 2026
Record last verified: 2026-04