Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-04-05 @ 10:26 PM
Study NCT ID:
NCT07433257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2025-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Local Corticosteroid Injection in Carpal Tunnel Syndrome Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014222', 'term': 'Triamcinolone Acetonide'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '12 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-21', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2026-02-21', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'before treatment, 4 weeks after treatment, 12 weeks after treatment', 'description': '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.\n\nHigher scores correspond to greater pain severity.'}, {'measure': 'Tinel Sign', 'timeFrame': 'before treatment, 4 weeks after treatment, 12 weeks after treatment', 'description': 'The Tinel sign will be conducted by a physician by percussing over the median nerve at the wrist.\n\nA positive sign is identified by the occurrence of tingling or "pins and needles" sensations in the palm, thumb, index finger, or middle finger.\n\nFindings will be documented as positive or negative.'}, {'measure': 'Phalen Test', 'timeFrame': 'before treatment, 4 weeks after treatment, 12 weeks after treatment', 'description': 'The Phalen test will be performed by a physician to assess median nerve compression.\n\nA 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.\n\nTest results will be recorded as positive or negative.'}, {'measure': 'Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)', 'timeFrame': 'before treatment, 4 weeks after treatment, 12 weeks after treatment', 'description': 'The Boston Carpal Tunnel Syndrome Questionnaire is a patient-reported outcome measure with two subscales: the Symptom Severity Scale and the Functional Status Scale.\n\nThe Symptom Severity Scale includes 11 items assessing symptoms such as pain, paresthesia, numbness, weakness, nocturnal complaints, and difficulty grasping objects.\n\nThe 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.\n\nEach 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).\n\nMean scores are calculated separately for each subscale, ranging from 1 to 5, with higher scores indicating greater symptom severity or poorer hand function.\n\nThe validated Turkish version of the questionnaire was used.'}, {'measure': 'Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)', 'timeFrame': 'before treatment, 4 weeks after treatment, 12 weeks after treatment', 'description': 'The Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) is a self-reported questionnaire used to evaluate neuropathic pain.\n\nTotal scores range from 0 to 24, with higher scores indicating greater neuropathic pain severity.\n\nA score of 12 or higher is considered indicative of neuropathic pain. The validated Turkish version of the questionnaire will be used in this study'}, {'measure': 'Hand Grip Strength', 'timeFrame': 'before treatment, 4 weeks after treatment, 12 weeks after treatment', 'description': '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.'}, {'measure': 'Pinch Strength', 'timeFrame': 'before treatment, 4 weeks after treatment, 12 weeks after treatment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Median Nerve Cross-Sectional Area (MNCSA)', 'timeFrame': 'before treatment, 4 weeks after treatment, 12 weeks after treatment', 'description': '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.'}, {'measure': 'Median Nerve Sensory Distal Latency', 'timeFrame': 'before treatment, 12 weeks after treatment', 'description': '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).'}, {'measure': 'Median Sensory Nerve Action Potential Amplitude', 'timeFrame': 'before treatment, 12 weeks after treatment', 'description': '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).'}, {'measure': 'Median Nerve Sensory Conduction Velocity', 'timeFrame': 'before treatment, 12 weeks after treatment', 'description': '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).'}, {'measure': 'Median Nerve Motor Distal Latency', 'timeFrame': 'before treatment, 12 weeks after treatment', 'description': '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).'}, {'measure': 'Median Nerve Compound Muscle Action Potential Amplitude', 'timeFrame': 'before treatment, 12 weeks after treatment', 'description': '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).'}, {'measure': 'Median Nerve Motor Conduction Velocity', 'timeFrame': 'before treatment, 12 weeks after treatment', 'description': '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).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carpal Tunnel Syndrome (CTS)', 'Type 2 Diabetes Mellitus (T2DM)']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Carpal Tunnel Syndrome with Type 2 Diabetes Mellitus Group (Group 1):\n\n * Age between 18 and 75 years\n * Presence of clinical symptoms compatible with carpal tunnel syndrome (e.g., pain, paresthesia, numbness) for at least 3 months\n * Patients diagnosed with mild-to-moderate carpal tunnel syndrome based on electrophysiological findings\n * Diagnosis of type 2 diabetes mellitus\n * Regulated blood glucose levels, defined as hemoglobin A1c (HbA1c) \\< 7%\n* Idiopathic Carpal Tunnel Syndrome Group (Group 2):\n\n * Age between 18 and 75 years\n * Presence of clinical symptoms consistent with carpal tunnel syndrome (e.g., pain, paresthesia, numbness) for at least 3 months\n * Patients diagnosed with mild-to-moderate carpal tunnel syndrome based on electrophysiological findings\n * No diagnosis of diabetes mellitus\n\nExclusion Criteria\n\n* Severe carpal tunnel syndrome based on electrophysiological findings\n* Presence of polyneuropathy, cervical radiculopathy, brachial plexopathy, or thoracic outlet syndrome\n* Uncontrolled blood glucose levels in the diabetic group (hemoglobin A1c ≥ 7%)\n* Presence of another systemic disease, other than diabetes mellitus, that may cause carpal tunnel syndrome\n* Presence of a rheumatological disease\n* History of wrist surgery\n* Less than 6 months since a local corticosteroid injection for carpal tunnel syndrome\n* Less than 3 months since completion of a physical therapy program for carpal tunnel syndrome\n* Infection at the intended injection site\n* Presence of malignancy\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT07433257', 'briefTitle': 'The Effect of Local Corticosteroid Injection in Carpal Tunnel Syndrome Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Haydarpasa Numune Training and Research Hospital'}, 'officialTitle': 'The Effect of Local Corticosteroid Injection on Electrophysiological and Ultrasonographic Findings in Carpal Tunnel Syndrome Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'HNEAH-GOEK 2024/130'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Carpal Tunnel Syndrome with Type 2 Diabetes Mellitus Group (Group 1)', 'description': 'Patients with mild-to-moderate carpal tunnel syndrome diagnosed by electrophysiological findings who also have a diagnosis of type 2 diabetes mellitus.\n\nTreatment consists of an injection containing 1 mL of 40 mg \\[40 mg/mL\\] triamcinolone acetonide + 1 mL of 2% lidocaine hydrochloride.', 'interventionNames': ['Drug: 1 mL 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL 2% lidocaine hydrochloride']}, {'label': 'Idiopathic Carpal Tunnel Syndrome Group (Group 2)', 'description': '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.', 'interventionNames': ['Drug: 1 mL 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL 2% lidocaine hydrochloride']}], 'interventions': [{'name': '1 mL 40 mg [40 mg/mL] triamcinolone acetonide + 1 mL 2% lidocaine hydrochloride', 'type': 'DRUG', 'description': "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.", 'armGroupLabels': ['Carpal Tunnel Syndrome with Type 2 Diabetes Mellitus Group (Group 1)', 'Idiopathic Carpal Tunnel Syndrome Group (Group 2)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'TALHA ÇELİK', 'role': 'CONTACT', 'email': 'talhacelikdr@gmail.com', 'phone': '+905062398047'}, {'name': 'Elem Yorulmaz', 'role': 'CONTACT', 'email': 'elem_inal@yahoo.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haydarpasa Numune Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Talha Çelik', 'investigatorAffiliation': 'Haydarpasa Numune Training and Research Hospital'}}}}