A Single-portal Endoscopic Approach Through Subcutaneous Tunnel for Carpal Tunnel Release

NCT05094778 | Completed DMC

• 1 other identifier: ShenzhenPH Zhuang03
• Study Type: interventional
• Target: 192
• Locations: 0 countries
• Sites: N/A

Brief Summary

Traditional endoscopic release directly accesses the carpal tunnel and thus carries a higher risk of nerve irritability, even nerve injury. Based on our anatomical study, the investigators developed a new endoscopic technique through a single-portal palm approach that passes superficially to palmar aponeurosis, and cut the full transverse carpal ligament. The investigators will compared the technique with the standard dual-portal endoscopic technique.

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal tunnel syndrome; carpal tunnel release; pain; nerve compression syndromes

Outcome Measures

Primary Outcomes (2)

• The sensibility of the pulps of thumb, index finger, and middle finger (mm)

  static 2-point discrimination (2PD) test is used for testing the sensibility of the pulps of digits. The range of normal value is 3 mm--5 mm, and higher scores mean a worse outcome

  3 years

• Severity of symptoms and functional status

  The Levine Questionnaire is regarded as a valuable assessment of severity of symptoms and functional status in carpal tunnel syndrome. It is self-administered and is in two sections. The symptoms severity scale is 11 questions and evaluates symptoms regarding severity, frequency, time and kind. The functional status scale is eight questions and evaluates how the syndrome affects daily life.Each question had five ordinal response categories ranging from 1 (no symptoms) to 5 (very severe symptoms). Responses to individual items were averaged to yield an overall score for each scale.

  3 years

Study Arms (1)

single-portal group

OTHER

The patients in single-portal group were treated with single-portal palm approach

Procedure: a single-portal palm approach

Interventions

a single-portal palm approach PROCEDURE

a single-portal palm approach that passes superficially to palmar aponeurosis, and cut the full transverse carpal ligament.

single-portal group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A confirmed diagnosis of carpal tunnel syndrome based on Evidence for Surgical Treatment issued by the British Society for Surgery of the Hand
• Symptoms of carpal tunnel syndrome had lasted\>2 months or inadequate responses to the non-surgical treatments≥3 months
• moderate to severe symptoms.

You may not qualify if:

• mild symptoms or prior injuries to the extremity
• bilateral wrists involved, a combined nerve compression, gout, diabetes or chronic renal failure.

Sponsors & Collaborators

• Shenzhen People's Hospital: lead
• Hebei Medical University Third Hospital: collaborator

Related Publications (2)

• Shi Q, Bobos P, Lalone EA, Warren L, MacDermid JC. Comparison of the Short-Term and Long-Term Effects of Surgery and Nonsurgical Intervention in Treating Carpal Tunnel Syndrome: A Systematic Review and Meta-Analysis. Hand (N Y). 2020 Jan;15(1):13-22. doi: 10.1177/1558944718787892. Epub 2018 Jul 17.

  PMID: 30015499 RESULT

• Wei R, Chen C, Liu Y, Liu Z, Xiong H, Zhang X, Zhuang Y. Endoscopic Release Superficial Rather Than Deep to the Transverse Carpal Ligament for Carpal Tunnel Syndrome Improves Immediate Postoperative Transient Symptomatic Exacerbation With Fewer Absences From Work. Arthroscopy. 2023 Apr;39(4):963-970.e2. doi: 10.1016/j.arthro.2022.09.013. Epub 2022 Oct 5.

  PMID: 36208712 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Pain; Nerve Compression Syndromes

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yongqing Zhuang

  Shenzhen People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2021
• First Posted: October 26, 2021
• Study Start: January 5, 2012
• Primary Completion: June 15, 2021
• Study Completion: August 30, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10