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

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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: long-axis needle release; Other: short-axis needle release

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

primary care clinic

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: long-axis group; The patients in the long-axis group received one session of ultrasound-guided long-axis needle release of transverse carpal ligament.	Other: long-axis needle release; The participants received one session of ultrasound-guided long-axis TCL needle release.
Active Comparator: short-axis group; The patients in the short-axis group received one session of ultrasound-guided short-axis needle release of transverse carpal ligament.	Other: short-axis needle release; The participants received one session of ultrasound-guided long-axis TCL needle release.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Study Chair: Jiaan Zhu, Dr, Peking University People's Hospital

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: carpal tunnel syndrome; ultrasound; transverse carpal ligament
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: 2024PHB019-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No