Afyonkarahisar Health Sciences University
Afyonkarahisar, 03200, Turkey (Türkiye)
Location status: Recruiting
Location contact
Ali İzzet AKÇİN, MD
CONTACT
Nuran EYVAZ, MD
CONTACT
NCT Number: NCT06243848
The aim of this study is to compare ultrasound-guided perineural injection of the median nerve with classic minimal incision surgical technique for median nerve decompression in patients diagnosed with mild, moderate, and severe carpal tunnel syndrome.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Afyonkarahisar, 03200, Turkey (Türkiye)
Location status: Recruiting
Ali İzzet AKÇİN, MD
CONTACT
Nuran EYVAZ, MD
CONTACT
Carpal tunnel syndrome represents the most prevalent type of entrapment neuropathy. Anatomically, the carpal tunnel is formed by the carpal bones and lies beneath the transverse carpal ligament, housing nine tendon sheaths of the forearm flexors along with the median nerve. From a clinical perspective, individuals with carpal tunnel syndrome typically experience sensory symptoms such as paresthesia and hypoesthesia, as well as motor impairments and pain within the region supplied by the median nerve, all resulting from mechanical compression and localized ischemia.
In the classification of CTS, participants are diagnosed with mild, moderate, or severe CTS, and various treatment options are available for each category. Treatment options aimed at alleviating symptoms include physical therapy, splinting, wrist injections, and surgical procedures Ultrasound-guided injections of peripheral nerves are typically more advantageous than blind injections because minimize the risk of damaging crucial vascular structures in the adjacent tissue alongside the nerves and decrease the likelihood of intraneural injections.
CTS can also be treated surgically, although the literature has not provided sufficient evidence to establish the superiority of one surgical technique over another. However, these procedures are known to be effective by reducing the volume of the carpal tunnel, thereby relieving pressure on the median nerve. In CTS surgery, following a mini-incision, the dissection proceeds through fat and fascial tissue until the flexor retinaculum is reached, ensuring decompression of the median nerve. The advantages of the mini-incision technique include the preservation of neurovascular structures, a low risk of complications, and a high level of patient satisfaction, making it a prominent surgical approach.
The aim of this study is to compare ultrasound-guided perineural injection of the median nerve with the classic minimal incision surgical technique for median nerve decompression in participants diagnosed with mild, moderate, and severe carpal tunnel syndrome.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Classic minimal incision surgical technique for median nerve decompression in patients diagnosed with mild, moderate, and severe carpal tunnel syndrome.
The median nerve will be identified using ultrasound at the proximal entrance of the carpal tunnel. Using an ulnar approach with the in-plane technique, it was planned to inject 5 cc of 5% dextrose around the median nerve.
Time frame: baseline and 12th week
Pain intensity was assessed using a visual analogue scale for pain, ranging from 0 to 10 mm, where 0 indicates the absence of pain and 10 signifies intense pain. This scale is widely recognized for its strong reliability and validity in measuring musculoskeletal pain.
Time frame: baseline and 12th week
The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a commonly used questionnaire for CTS, comprising two main components. It assesses severity using two categories: a symptom severity scale with 11 questions and a functional status scale with 8 questions. Each question is rated on a scale of 0 to 5, where 0 indicates no difficulties during the activity, and 5 indicates extremely severe dysfunction.
Time frame: baseline and 12th week
The median nerve's cross-sectional area (CSA) will be assessed at the scaphoid-pisiform level using an ultrasound. Three measurements will be taken, and the analysis will utilize the average of these three measurements.
CSA values increase as clinical findings worsen.
Time frame: baseline and 12th week
Antidromic sensory nerve conduction velocity and distal motor latency of the median nerve will be assessed for all patients. These measurements will be performed three times, and the resulting average value will be considered. CTS will be identified as mild, modarate or severe by electrophysiologic evaluations.
Time frame: baseline and 12th week
The participants' hand grip strength will be assessed using the "Jamar Hydrolic Hand Dynamometer." . Patients will be instructed to exert maximum force, and each measurement will be repeated three times, with the averages recorded in kilograms. Higher scores indicate better grip strength.
Time frame: baseline and 12th week
Finger grip strength will be evaluated using the "Jamar Digital Pinchmeter." Measurements will be taken bilaterally in three different hand positions: lateral, palmar, and fingertip grips. Higher average scores indicate better finger grip strength. The maximum force exerted during each trial in kilograms will be recorded.
Contact information is provided by the study sponsor or research team.
Ali İzzet AKÇİN, MD
CONTACT
Nuran EYVAZ, MD
CONTACT
Afyonkarahisar Health Sciences University
Other
Comparison of Ultrasound-Guided Injection With Traditional Median Nerve Decompression Surgery in Patients With Carpal Tunnel Syndrome: Randomized Controlled Study
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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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