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Clinical Trials/NCT06251674
NCT06251674
Completed
Not Applicable

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

Peking University People's Hospital1 site in 1 country60 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carpal Tunnel Syndrome
Sponsor
Peking University People's Hospital
Enrollment
60
Locations
1
Primary Endpoint
visual analogue scale(VAS) scores
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
December 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zhu Jiaan

Professor

Peking University People's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

visual analogue scale(VAS) scores

Time Frame: 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 Outcomes

  • cross-sectional area(CSA) of the median nerve(Baseline as well as 1 month, 3 month and 6 months after injection.)
  • Boston carpal tunnel syndrome questionnaire(BCTQ)(Baseline as well as 1 month, 3 month and 6 months after injection.)

Study Sites (1)

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