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

Comparison of Ultrasound-guided Transverse Carpal Ligament Needle Release Via Different Approaches for Patients With Mild-to-moderate Carpal Tunnel Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06251674
Enrollment
60
Registered
2024-02-09
Start date
2020-01-01
Completion date
2023-12-30
Last updated
2024-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

transverse carpal ligament, ultrasound, carpal tunnel syndrome

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.

Interventions

OTHERlong-axis needle release

The participants received one session of ultrasound-guided long-axis TCL needle release.

OTHERshort-axis needle release

The participants received one session of ultrasound-guided long-axis TCL needle release.

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
visual analogue scale(VAS) scoresBaseline 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

MeasureTime frameDescription
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.
cross-sectional area(CSA) of the median nerveBaseline 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026