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Completed

NCT Number: NCT06251674

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

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.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

long-axis needle release

Other

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

short-axis needle release

Other

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

Primary outcomes

  1. 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

  1. Boston carpal tunnel syndrome questionnaire(BCTQ)

    Time frame: 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.

  2. cross-sectional area(CSA) of the median nerve

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Feb 9, 2024
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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