The Effect of Local Corticosteroid Injection in Carpal Tunnel Syndrome Patients With Type 2 Diabetes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorHaydarpasa Numune Training and Research Hospital

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 1 mL 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL 2% lidocaine hydrochloride

    Drug

    Both 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

60 Participants
are divided into 2 treatment groups
Group A: Carpal Tunnel Syndrome with Type 2 Diabetes Mellitus Group (Group 1)1 intervention
Group B: Idiopathic Carpal Tunnel Syndrome Group (Group 2)1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
before treatment, 4 weeks after treatment, 12 weeks after treatment
2

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.

Time frame
before treatment, 4 weeks after treatment, 12 weeks after treatment
3

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.

Time frame
before treatment, 4 weeks after treatment, 12 weeks after treatment
4

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.

Time frame
before treatment, 4 weeks after treatment, 12 weeks after treatment

Secondary outcomes

1

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.

Time frame
before treatment, 4 weeks after treatment, 12 weeks after treatment
2

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).

Time frame
before treatment, 12 weeks after treatment
3

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).

Time frame
before treatment, 12 weeks after treatment
4

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).

Time frame
before treatment, 12 weeks after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.