Clinical trial NCT06251674: Efficacy of Ultrasound-guided Transverse Carpal Ligament Release for Carpal Tunnel Syndrome
Official title: Comparison of Ultrasound-guided Transverse Carpal Ligament Needle Release Via Different Approaches for Patients With Mild-to-moderate Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: transverse carpal ligament
ultrasound
carpal tunnel syndrome
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: visual analogue scale(VAS) scores
timeFrame: Baseline as well as 1 month, 3 month and 6 months after injection.
Secondary outcomes:
measure: Boston carpal tunnel syndrome questionnaire(BCTQ)
timeFrame: Baseline as well as 1 month, 3 month and 6 months after injection.
measure: cross-sectional area(CSA) of the median nerve
timeFrame: Baseline as well as 1 month, 3 month and 6 months after injection.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Jiaan Zhu, Dr
role: STUDY_CHAIR
References:
citation: Wipperman J, Goerl K. Carpal Tunnel Syndrome: Diagnosis and Management. Am Fam Physician. 2016 Dec 15;94(12):993-999.
citation: Orhurhu V, Orman S, Peck J, Urits I, Orhurhu MS, Jones MR, Manchikanti L, Kaye AD, Odonkor C, Hirji S, Cornett EM, Imani F, Varrassi G, Viswanath O. Carpal Tunnel Release Surgery- A Systematic Review of Open and Endoscopic Approaches. Anesth Pain Med. 2020 Dec 26;10(6):e112291. doi: 10.5812/aapm.112291. eCollection 2020 Dec.
citation: Petrover D, Richette P. Treatment of carpal tunnel syndrome : from ultrasonography to ultrasound guided carpal tunnel release. Joint Bone Spine. 2018 Oct;85(5):545-552. doi: 10.1016/j.jbspin.2017.11.003. Epub 2017 Nov 16.