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

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.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Sprains and Strains Wounds and Injuries

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Conduct a multi-center, comparison clinical trial according to clinical Trial Reporting Standards (CONSORT). Patients in the single-portal group were treated with a single-portal palm approach that passes superficially to palmar aponeurosis and cut the full transverse carpal ligament. The comparison group were treated with Chow endoscopic technique. In order to assess efficiency of single-portal palm approach, the investigators will compared the technique with the standard dual-portal endoscopic technique. The study was approved by Shenzhen People's Hospital and informed consent was signed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

a single-portal palm approach

Procedure

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

Primary outcomes

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

Time frame: 3 years

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
Severity of symptoms and functional status

Time frame: 3 years

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.

Sponsors and collaborators

Lead sponsor

Shenzhen People's Hospital

Other

Collaborators

Hebei Medical University Third Hospital

Registry information

Important dates

Study start: 2012
Primary completion: 2021
Study completion: 2021
First posted: Oct 26, 2021
Registry last updated: Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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