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

NCT07433257 | Not Yet Recruiting

• 1 other identifier: HNEAH-GOEK 2024/130
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome (CTS); Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (7)

• Median Nerve Cross-Sectional Area (MNCSA)

  before treatment, 4 weeks after treatment, 12 weeks after treatment

• Median Nerve Sensory Distal Latency

  before treatment, 12 weeks after treatment

• Median Sensory Nerve Action Potential Amplitude

  before treatment, 12 weeks after treatment

• Median Nerve Sensory Conduction Velocity

  before treatment, 12 weeks after treatment

• Median Nerve Motor Distal Latency

  before treatment, 12 weeks after treatment

Study Arms (2)

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

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

Interventions

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.

Carpal Tunnel Syndrome with Type 2 Diabetes Mellitus Group (Group 1); Idiopathic Carpal Tunnel Syndrome Group (Group 2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Diabetes Mellitus, Type 2

Interventions

Triamcinolone Acetonide; Lidocaine

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

TALHA ÇELİK

CONTACT

+905062398047; talhacelikdr@gmail.com

Elem Yorulmaz

CONTACT

elem_inal@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: February 25, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02