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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06251674
• Other study ID #: 2024PHB019-001
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2024
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Other:
• long-axis needle release
The participants received one session of ultrasound-guided long-axis TCL needle release.
• short-axis needle release
The participants received one session of ultrasound-guided long-axis TCL needle release.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View Citation

Wipperman J, Goerl K. Carpal Tunnel Syndrome: Diagnosis and Management. Am Fam Physician. 2016 Dec 15;94(12):993-999. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue scale(VAS) scores	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).	Baseline as well as 1 month, 3 month and 6 months after injection.
Secondary	Boston carpal tunnel syndrome questionnaire(BCTQ)	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.	Baseline as well as 1 month, 3 month and 6 months after injection.
Secondary	cross-sectional area(CSA) of the median nerve	CSA of the median nerve under ultrasound guidance reflects the severity of the disease to some extent	Baseline as well as 1 month, 3 month and 6 months after injection.