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

The Effect of Local Corticosteroid Injection on Electrophysiological and Ultrasonographic Findings in Carpal Tunnel Syndrome Patients With Type 2 Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus (T2DM); Carpal Tunnel Syndrome (CTS)
• Intervention / Treatment: Drug: 1 mL 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL 2% lidocaine hydrochloride

Detailed Description

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 were diagnosed with mild-to-moderate carpal tunnel syndrome based on electrophysiological findings, and who were indicated for interventional procedures and received corticosteroid + local anesthetic injections. Data from patients meeting the inclusion and exclusion criteria will be included in the study. Demographic and clinical data such as age, gender, height, weight, occupation, and dominant hand, as recorded in the patients' follow-up documents, will be recorded. In addition, the VAS (Visual Analog Scale), Tinel sign and Phalen test, Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ), Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS), Median Nerve Cross-Sectional Area (MNCSA) measured by ultrasound, MNCSA measurement at the pisiform-scaphoid level, and electromyography (EMG)-nerve conduction study results will be noted. Patients will be divided into two groups: Group 1 (patients with Type 2 Diabetes Mellitus diagnosed with Carpal Tunnel Syndrome) and Group 2 (patients with Idiopathic Carpal Tunnel Syndrome). Details of the treatment administered before patients are included in the study will be as follows: Both groups will receive an injection containing corticosteroid + local anesthetic in the form of 1 milliliter (mL) of 40 milligrams (mg) [40 mg/mL] triamcinolone acetonide + 1 mL of 2% lidocaine hydrochloride using the 'ulnar in-plane' technique guided by ultrasonography. All evaluation parameters (except electrophysiological evaluations) will be obtained from data recorded before treatment, at week 4 after treatment, and at week 12 after treatment. Electrophysiological parameters will be obtained from data recorded before treatment and at week 12 after treatment. Intra-group and inter-group differences will be statistically analyzed.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: TALHA ÇELİK; Phone Number: +905062398047; Email: talhacelikdr@gmail.com
• Study Contact Backup: Name: Elem Yorulmaz; Email: elem_inal@yahoo.com

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34668
      • Recruiting
      • Istanbul Haydarpasa Numune Training and Research Hospital
      • Contact: Talha Celik, MD; Phone Number: +905062398047; Email: talhacelikdr@gmail.com
      • Contact: Elem Yorulmaz, MD; Email: elem_inal@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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

Description

Inclusion Criteria

• Carpal Tunnel Syndrome with Type 2 Diabetes Mellitus Group (Group 1):

  • 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
  • Regulated blood glucose levels, defined as hemoglobin A1c (HbA1c) < 7%

• Idiopathic Carpal Tunnel Syndrome Group (Group 2):

  • Age between 18 and 75 years
  • Presence of clinical symptoms consistent 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
  • No diagnosis of diabetes mellitus

Exclusion Criteria

• 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
• Presence of a rheumatological disease
• History of wrist surgery
• Less than 6 months since a local corticosteroid injection for carpal tunnel syndrome
• Less than 3 months since completion of a physical therapy program for carpal tunnel syndrome
• Infection at the intended injection site
• Presence of malignancy
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Carpal Tunnel Syndrome with Type 2 Diabetes Mellitus Group (Group 1); Patients with mild-to-moderate carpal tunnel syndrome diagnosed by electrophysiological findings who also have a diagnosis of type 2 diabetes mellitus. Treatment consists of an injection containing 1 mL of 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL of 2% lidocaine hydrochloride.	Drug: 1 mL 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL 2% lidocaine hydrochloride; 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.
Idiopathic Carpal Tunnel Syndrome Group (Group 2); Patients with mild-to-moderate idiopathic carpal tunnel syndrome diagnosed by electrophysiological findings, without a diagnosis of diabetes mellitus. Treatment consists of an injection containing 1 mL of 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL of 2% lidocaine hydrochloride.	Drug: 1 mL 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL 2% lidocaine hydrochloride; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before treatment, 4 weeks after treatment, 12 weeks after treatment
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.	before treatment, 4 weeks after treatment, 12 weeks after treatment
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.	before treatment, 4 weeks after treatment, 12 weeks after treatment
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.	before treatment, 4 weeks after treatment, 12 weeks after treatment
Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)	The Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) is a self-reported questionnaire used to evaluate neuropathic pain. Total scores range from 0 to 24, with higher scores indicating greater neuropathic pain severity. A score of 12 or higher is considered indicative of neuropathic pain. The validated Turkish version of the questionnaire will be used in this study	before treatment, 4 weeks after treatment, 12 weeks after treatment
Hand Grip Strength	Hand grip strength will be measured using a hand-held dynamometer . Three measurements will be obtained, and the mean value will be recorded in kilograms (kg). Higher values indicate greater muscle strength.	before treatment, 4 weeks after treatment, 12 weeks after treatment
Pinch Strength	Pinch strength will be assessed using a pinchmeter , including tip pinch, lateral pinch, and palmar pinch. Each measurement will be repeated three times, and the average value will be recorded in kilograms (kg). Higher values indicate greater muscle strength.	before treatment, 4 weeks after treatment, 12 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before treatment, 4 weeks after treatment, 12 weeks after treatment
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).	before treatment, 12 weeks after treatment
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).	before treatment, 12 weeks after treatment
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).	before treatment, 12 weeks after treatment
Median Nerve Motor Distal Latency	Median nerve motor distal latency will be measured using electromyography (EMG) with nerve conduction studies (NCS). The parameter represents the time interval between distal electrical stimulation and the recorded motor response of the median nerve. Results will be reported in milliseconds (ms).	before treatment, 12 weeks after treatment
Median Nerve Compound Muscle Action Potential Amplitude	Median nerve compound muscle action potential (CMAP) amplitude will be measured using electromyography (EMG) with nerve conduction studies (NCS) following stimulation of the median nerve. The parameter represents the magnitude of the recorded motor response. Results will be reported in millivolts (mV).	before treatment, 12 weeks after treatment
Median Nerve Motor Conduction Velocity	Median nerve motor conduction velocity will be measured using electromyography (EMG) with nerve conduction studies (NCS). The parameter represents the speed of impulse transmission along the motor fibers of the median nerve. Results will be reported in meters per second (m/s).	before treatment, 12 weeks after treatment

Collaborators and Investigators

• Sponsor: Haydarpasa Numune Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: February 21, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 23, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Metabolic Diseases; Peripheral Nervous System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Carpal Tunnel Syndrome; Organic Chemicals; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Lidocaine; Triamcinolone Acetonide
• Other Study ID Numbers: HNEAH-GOEK 2024/130

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No