Efficacy of Ultrasound-guided Transverse Carpal Ligament Release for Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Other: long-axis needle release; Other: short-axis needle release

• Registration Number: NCT06251674
• Lead Sponsor: Peking University People's Hospital

Brief Summary

Carpal tunnel syndrome (CTS) is one of the most common peripheral nerve entrapment neuropathies, and it is characterized by pain, numbness, tingling, and weakness in the regions innervated by the median nerve (MN). CTS is believed to result from compression of the MN as it passes through the narrowed carpal tunnel with regard to gradual ischemia and fibrosis.Ultrasound-guided needle release of transverse carpal ligament(TCL) is an effective method to decompress the carpal.There are two main approaches to perform the release, short-axis or long-axis. However, there is no consensus about the optimal strategy.Thus, this study aimed to compare the efficacy of these two approaches for patients with mild-to-moderate CTS.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-02
• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-01
• Last Update Submitted: 2024-02-08
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 18-80 years old
• typical clinical signs of CTS present for at least three months, including pain, numbness, and tingling of the hands
• positive Phalen or Tinel sign
• electrophysiological parameters supportive of mild to moderate CTS
• high-resolution ultrasonography demonstrated MN compression at the carpal.

Exclusion Criteria

• bifid MN or bilateral CTS
• pregnancy
• disorders such as rheumatic immune diseases, chronic renal failure, diabetes mellitus, hypothyroidism and other systemic diseases
• any accompanying disorder that could mimic CTS, such as thoracic outlet syndrome, cervical radiculopathy, polyneuropathy, proximal median nerve entrapment
• history of carpal tunnel surgery or injection into the affected carpal tunnel
• CTS caused by trauma, surgery, intracarpal lesions, or MN lesions malignant tumors or severe cardiorespiratory diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
long-axis group	long-axis needle release	The patients in the long-axis group received one session of ultrasound-guided long-axis needle release of transverse carpal ligament.
short-axis group	short-axis needle release	The patients in the short-axis group received one session of ultrasound-guided short-axis needle release of transverse carpal ligament.

Primary Outcome Measures

Name	Time	Method
visual analogue scale(VAS) scores	Baseline as well as 1 month, 3 month and 6 months after injection.	The VAS scores is the most common tool to assess the level of pain. Possible scores range from 0(no pain) to 10(worst possible pain).

Secondary Outcome Measures

Name	Time	Method
cross-sectional area(CSA) of the median nerve	Baseline as well as 1 month, 3 month and 6 months after injection.	CSA of the median nerve under ultrasound guidance reflects the severity of the disease to some extent
Boston carpal tunnel syndrome questionnaire(BCTQ)	Baseline as well as 1 month, 3 month and 6 months after injection.	BCTQ is the most commonly used evaluation for CTS symptoms; it contains two subscales: 11 items of symptom severity scale(SSS) and 8 items of functional status scale(FSS). Each item was scored 1-5 scores, with higher scores indicating greater severity and dysfunction.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China