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Trials / Completed

CompletedNCT06400433

Comparing Efficacies of Median Nerve Hydrodissection With Dexamethasone and Dextrose in Carpal Tunnel Syndrome

Comparison of the Efficacy of Ultrasound-Guided Median Nerve Hydrodissection With Dexamethasone and Dextrose at Different Volumes in Patients With Carpal Tunnel Syndrome: A Prospective, Randomized, Double Blind Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
88 (actual)
Sponsor
Istanbul University - Cerrahpasa · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The aim of this study is to compare the efficacy of ultrasonography-guided hydrodissection technique with 5% dextrose and dexamethasone injectates when applied in different volumes in the treatment of mild to moderate carpal tunnel syndrome.

Detailed description

Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment neuropathy worldwide, resulting from the compression of the median nerve in the carpal tunnel, an osteofibrous canal whose roof is formed by the flexor retinaculum and whose floor is formed by the carpal bones. CTS accounts for approximately 90% of all entrapment neuropathies, and an individual's lifetime risk of diagnosis is estimated to be 10%. It is estimated that about 5% of the population suffers from CTS. It is more common in women compared to men and at least half of the cases manifests between the ages of 40 and 60. In clinical practice, the most common complaints of patients include neuropathic symptoms along the distribution of the median nerve. These complaints, which initially occur and flare up at night and intermittently during the day, may become continuous and worsen in the later stages of the disease. Taking an accurate history and clinical assessment is crucial for diagnosis. Evaluation of sensory abnormalities, loss of two point discrimination, and the strength of abductor pollicis brevis muscle can provide information about functional impairment. Tinel's sign and Phalen's manoeuvre are some of diagnostic tests. Some scales and questionnaires are used in diagnosis and assessment of functionality. Ultrasonography is a useful, inexpensive and easily accessible method to simultaneously observe morphological changes in the median nerve and scan the surrounding anatomy. Electrophysiological assessment is very sensitive in examining median nerve dysfunction caused by nerve damage. Nerve conduction studies are considered the gold standard method in diagnosis, determining prognosis and making treatment decisions. The management of CTS in patients depends on the severity of the disease. In mild and moderate circumstances conservative treatments are recommended for the patients. Surgery is typically considered for patients with moderate to severe CTS or individuals who do not experience significant improvement with conservative treatments. Conservative treatments include patient education, wrist splinting, medical treatments, physical therapy, and perineural injections. Ultrasound-guided nerve hydrodissection injection has emerged as a therapeutic approach with less complications for CTS. This method aims to achieve mechanical release from perineural adhesions by creating a perineural fluid plane.Various injectates such as normal saline, 5% dextrose, and platelet-rich plasma,viscosupplements are commonly used for hydrodissection. Many studies have been conducted with the hypothesis that the injection volume, in addition to the injection preparation, would also be important in median nerve hydrodissection, and different results have been obtained. This study aimed to compare the clinical, ultrasonographic and electrophysiological improvement in patients by applying different volumes of dexamethasone and dextrose in median nerve hydrodissection. Patients will be evaluated before and after treatment at 2nd, 4th and 12th weeks ultrasonographically, electrophysiologically and clinically with pain scores, handgrip strength assesment, two-point discrimination values, functional and disability scales.

Conditions

Interventions

TypeNameDescription
PROCEDUREUltrasound-guided median nerve hydrodissectionInjected wrist will be supinated and slightly dorsiflexed. The transducer of the ultrasound will be placed transversely at the proximal carpal inlet. After sterile preparation, a 22 gauge needle will be inserted using the short-axis technique, in-plane ulnar approach. During hydrodissection, separation of either between the median nerve and flexor retinaculum or between the median nerve and the underlying flexor tendons will be visually confirmed.

Timeline

Start date
2024-05-13
Primary completion
2024-09-23
Completion
2024-09-30
First posted
2024-05-06
Last updated
2025-01-31

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06400433. Inclusion in this directory is not an endorsement.