About this trial
Our study was planned as a prospective observational study aiming to compare the post-intervention recovery process between patients with carpal tunnel syndrome (CTS) and diabetes mellitus and patients with idiopathic carpal tunnel syndrome without diabetes mellitus. Patients who presented to the Physical Medicine and Rehabilitation outpatient clinic with clinical symptoms consistent with carpal tunnel syndrome and who were diagnosed with mild to moderate carpal tunnel syndrome based on electrophysiological findings and who received corticosteroid + local anesthetic injection will be included in the study. Data from patients who meet the inclusion and exclusion criteria will be included in the study. Patients' demographic and clinical data will be recorded. Records will be taken before treatment and at 4 and 12 weeks after treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 75 years
Presence of clinical symptoms compatible with carpal tunnel syndrome (e.g., pain, paresthesia, numbness) for at least 3 months
Patients diagnosed with mild-to-moderate carpal tunnel syndrome based on electrophysiological findings
Diagnosis of type 2 diabetes mellitus
Disqualifiers
Severe carpal tunnel syndrome based on electrophysiological findings
Presence of polyneuropathy, cervical radiculopathy, brachial plexopathy, or thoracic outlet syndrome
Uncontrolled blood glucose levels in the diabetic group (hemoglobin A1c ≥ 7%)
Presence of another systemic disease, other than diabetes mellitus, that may cause carpal tunnel syndrome
Trial population
Patients who presented to the Physical Medicine and Rehabilitation outpatient clinic with clinical symptoms consistent with carpal tunnel syndrome and were diagnosed with mild-to-moderate carpal tunnel syndrome
Trial design
Case-control
Prospective
Treatments tested in this trial
1 mL 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL 2% lidocaine hydrochloride
DrugBoth groups will receive an injection containing 1 mL of 40 mg \[40 mg/mL\] triamcinolone acetonide + 1 mL of 2% lidocaine hydrochloride, administered using the 'ulnar in-plane' technique under ultrasound guidance.
Treatment groups
Trial outcomes
Primary outcomes
Visual Analog Scale (VAS)
Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will rate their pain on a numeric scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst imaginable pain. Higher scores correspond to greater pain severity.
Tinel Sign
The Tinel sign will be conducted by a physician by percussing over the median nerve at the wrist. A positive sign is identified by the occurrence of tingling or "pins and needles" sensations in the palm, thumb, index finger, or middle finger. Findings will be documented as positive or negative.
Phalen Test
The Phalen test will be performed by a physician to assess median nerve compression. A positive test is defined as the reproduction of pain or paresthesia in the palmar region, thumb, index finger, or middle finger during sustained wrist flexion. Test results will be recorded as positive or negative.
Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
The Boston Carpal Tunnel Syndrome Questionnaire is a patient-reported outcome measure with two subscales: the Symptom Severity Scale and the Functional Status Scale. The Symptom Severity Scale includes 11 items assessing symptoms such as pain, paresthesia, numbness, weakness, nocturnal complaints, and difficulty grasping objects. The Functional Status Scale consists of 8 items evaluating hand-related functional abilities, including writing, buttoning clothes, holding a book while reading, gripping a telephone, opening jars, performing household activities, carrying shopping bags, and personal care tasks. Each item is scored on a 5-point Likert scale from 1 (no symptoms or no difficulty) to 5 (very severe symptoms or inability to perform the activity). Mean scores are calculated separately for each subscale, ranging from 1 to 5, with higher scores indicating greater symptom severity or poorer hand function. The validated Turkish version of the questionnaire was used.
Secondary outcomes
Median Nerve Cross-Sectional Area (MNCSA)
The Median Nerve Cross-Sectional Area (MNCSA) will be evaluated using ultrasonography at the level of the carpal tunnel inlet, defined anatomically by the scaphoid bone on the radial side and the pisiform bone on the ulnar side. The median nerve will be imaged in the transverse plane, and the cross-sectional area will be measured by manually tracing the hyperechoic epineurial border surrounding the nerve. Each measurement will be repeated three times, and the mean value will be used for analysis.
Median Nerve Sensory Distal Latency
Median nerve sensory distal latency will be measured using electromyography (EMG) with nerve conduction studies (NCS). The parameter represents the time interval between electrical stimulation and the recorded sensory response of the median nerve. Results will be reported in milliseconds (ms).
Median Sensory Nerve Action Potential Amplitude
Median sensory nerve action potential amplitude will be measured using electromyography (EMG) with nerve conduction studies (NCS). The parameter represents the magnitude of the recorded sensory response of the median nerve following electrical stimulation. Results will be reported in microvolts (µV).
Median Nerve Sensory Conduction Velocity
Median nerve sensory conduction velocity will be measured using electromyography (EMG) with nerve conduction studies (NCS). The parameter represents the speed of impulse transmission along the sensory fibers of the median nerve. Results will be reported in meters per second (m/s).
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