Clinical Trials Directory

Trials / Completed

CompletedNCT05222126

Efficacy of Ultrasound-Guided Hydrodissection in Carpal Tunnel Syndrome

Efficacy of Ultrasound-Guided Hydrodissection in Patients With Carpal Tunnel Syndrome

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Afyonkarahisar Health Sciences University · Academic / Other
Sex
All
Age
20 Years – 60 Years
Healthy volunteers
Not accepted

Summary

The aim of our study is to determine the effectiveness of US-guided hydrodissection of the median nerve in different contents and volumes in patients diagnosed with mild to moderate carpal tunnel syndrome.

Detailed description

Carpal tunnel syndrome is the most common form of entrapment neuropathies. Anatomically, the roof of the carpal tunnel consists of carpal bones, it is located under the transverse carpal ligament, and there are 9 tendon packs of the forearm flexors and the median nerve. Clinically, sensory (paresthesia and hypoesthesia), motor deficits and pain occur in the distribution of the median nerve secondary to mechanical compression and local ischemia. Conservative treatment options are available for patients diagnosed with mild and moderate CTS as a result of CTS classification. Treatment options for symptom relief include physical therapy applications, splinting, and wrist injections. Among local injection treatments; applications such as corticosteroids and local anesthetics are included. Ultrasound-guided injections of peripheral nerves are generally superior to blind injections as they prevent damage to critical vascular structures in the surrounding tissue accompanying the nerves and reduce the risk of intraneural injections. Ultrasound (US) guided hydrodissection of peripheral nerves (HD) is a technique that uses high-resolution ultrasound-guided fluid injection to separate nerves from a surrounding or adjacent structure, usually fascia. The aim is to restore function to the nerve and to release soft tissue adhesions that cause entrapment. This investigation was designed double-blind prospective randomized study. Participants were randomized into 4 groups: Ultrasound-guided Hydrodissection (HD) with 5 cc 5% dextrose, Ultrasound-guided Hydrodissection (HD) with 5 cc normal saline, Ultrasound-guided Hydrodissection (HD) with 10 cc 5% dextrose, Ultrasound-guided Hydrodissection (HD) with 10 cc normal saline. Ultrasonographic evaluation and ultrasound-guided injection were planned to be performed with the 10-18-MHz linear probe of the MyLab 70 (Esaote, Genova, Italy) device by a physician experienced in US. It was designed in such a way that the physician was blind to the clinical information of the patients and the injected material. As evaluation parameters, Visual Analogue Scale (VAS), Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), Cross-sectional Area of Median Nerve (CSA), Hand and finger grip strength assessment, and Electrophysiological assessment will be evaluated. It was planned that the evaluations were made and recorded by a blinded physician to the groups at the beginning of the treatment, at the 1st month and at the 3rd month controls.

Conditions

Interventions

TypeNameDescription
PROCEDUREUltrasound-guided Hydrodissection (HD) with 5 cc 5% DextroseThe median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, first it was planned to hydrodissect the median nerve from the retinaculum superiorly and then from the flexor tendons inferiorly, using 5 cc of 5% dextrose.
PROCEDUREUltrasound-guided Hydrodissection (HD) with 5 cc Normal SalineThe median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, first it was planned to hydrodissect the median nerve from the retinaculum superiorly and then from the flexor tendons inferiorly, using 5 cc normal saline.
PROCEDUREUltrasound-guided Hydrodissection (HD) with 10 cc 5% DextroseThe median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, first it was planned to hydrodissect the median nerve from the retinaculum superiorly and then from the flexor tendons inferiorly, using 10 cc 5% dextrose.
PROCEDUREUltrasound-guided Hydrodissection (HD) with 10 cc Normal SalineThe median nerve will be defined at the proximal entrance of the carpal tunnel (scaphoid-pisiform plane). Under the ulnar approach with the in-plane technique, first it was planned to hydrodissect the median nerve from the retinaculum superiorly and then from the flexor tendons inferiorly, using 10 cc normal saline.

Timeline

Start date
2022-09-20
Primary completion
2023-12-20
Completion
2024-01-10
First posted
2022-02-03
Last updated
2024-01-11

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05222126. Inclusion in this directory is not an endorsement.