About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The presence of symptoms such as nocturnal, posture-related, or movement-related paresthesias, along with possible pain, in the area supplied by the median nerve in the hand, lasting for more than 3 months.
Confirmation of mild, moderate or severe CTS through electrophysiological testing.
Numbness and loss of sensation in the hand's regions innervated by the median nerve, as well as weakness in the thenar muscles innervated by the median nerve.
Positive results on either the Phalen test and/or Tinel sign.
Disqualifiers
Individuals who may exhibit symptoms mimicking carpal tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
Patients who have received a previous injection into the carpal tunnel within the past 6 months.
Thenar muscle atrophy.
A history of prior carpal tunnel surgery.
Trial design
Parallel
Treatments tested in this trial
Minimal Incision Surgery for median nerve decompression
Procedure/SurgeryClassic minimal incision surgical technique for median nerve decompression in patients diagnosed with mild, moderate, and severe carpal tunnel syndrome.
Ultrasound-guided perineural injection with 5 cc 5% Dextrose
Procedure/SurgeryThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline visual analog scale (VAS) wrist pain at 4th 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.
Secondary outcomes
Change from baseline Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) at 4th 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.
Change from baseline Cross-sectional area of the Median Nerve (CSA) at 4th 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.
Change from baseline Electrophysiological Evaluation at 4th 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.
Change from baseline Hand Grip Strength Assessment at 4th 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.
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