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

NCT06251674 | Completed DMC

• 1 other identifier: 2024PHB019-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

transverse carpal ligament; ultrasound; carpal tunnel syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Boston carpal tunnel syndrome questionnaire(BCTQ)

  Baseline as well as 1 month, 3 month and 6 months after injection.

• cross-sectional area(CSA) of the median nerve

  Baseline as well as 1 month, 3 month and 6 months after injection.

Study Arms (2)

long-axis group

EXPERIMENTAL

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

short-axis group

ACTIVE COMPARATOR

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

Interventions

long-axis needle release OTHER

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

long-axis group

short-axis needle release OTHER

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

short-axis group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100032, China

Location

Related Publications (3)

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

  PMID: 28075090 BACKGROUND

• 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.

  PMID: 34150584 BACKGROUND

• 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.

  PMID: 29154980 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Jiaan Zhu, Dr

  Peking University People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: January 1, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

CN (1)