Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 8:49 PM
Study NCT ID:
NCT07435961
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetotherapy in Carpal Tunnel Syndrome: Randomized Controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D020423', 'term': 'Median Neuropathy'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Both the researcher/ evaluator and the particapant are blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, Randomized, Placebo-Controlled, Double-Blind Study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-21', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-02-21', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom Severity Assessed by Boston Carpal Tunnel Questionnaire Symptom Severity Scale', 'timeFrame': 'Baseline (Week 0), Week 3, Month 1, Month 3', 'description': 'The Boston Carpal Tunnel Questionnaire Symptom Severity Scale is an 11-item patient-reported outcome measure assessing the severity and frequency of carpal tunnel syndrome symptoms. Each item is scored from 1 (no symptoms) to 5 (most severe symptoms). The final score is calculated as the mean of all items, ranging from 1 to 5. Higher scores indicate more severe symptoms and worse clinical outcome.'}, {'measure': 'Wrist Pain Intensity Assessed by Visual Analog Scale', 'timeFrame': 'Baseline (Week 0), Week 3, Month 1, Month 3', 'description': 'Pain intensity will be measured using a 10-centimeter Visual Analog Scale. The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores indicate greater pain severity and worse outcome.'}, {'measure': 'Upper Extremity Function Assessed by Quick Disabilities of the Arm, Shoulder and Hand Questionnaire', 'timeFrame': 'Baseline (Week 0), Week 3, Month 1, Month 3', 'description': 'Upper extremity function will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand Questionnaire. This 11-item validated questionnaire is scored on a 5-point Likert scale and transformed to a total score ranging from 0 to 100. A score of 0 represents no disability and 100 represents maximum disability. Higher scores indicate worse functional impairment.'}, {'measure': 'Hand Grip Strength Assessed by Jamar Dynamometer', 'timeFrame': 'Baseline (Week 0), Week 3, Month 1, Month 3', 'description': 'Hand grip strength will be measured using a calibrated Jamar dynamometer and recorded in kilograms (kg). Higher values indicate greater muscle strength and better functional outcome.'}, {'measure': 'Sensory Function Assessed by Semmes-Weinstein Monofilament Test', 'timeFrame': 'Baseline (Week 0), Week 3, Month 1, Month 3', 'description': 'Sensory function will be evaluated using the Semmes-Weinstein Monofilament Test. Calibrated monofilaments of different thicknesses are applied to standardized fingertip locations to determine sensory threshold levels. Monofilament values range from lower to higher force levels. Higher threshold values indicate greater sensory impairment, whereas lower threshold values indicate better sensory function.'}, {'measure': 'Median Nerve Cross-Sectional Area Assessed by Ultrasonography', 'timeFrame': 'Baseline (Week 0), Week 3, Month 1, Month 3', 'description': 'The cross-sectional area of the median nerve will be measured at the carpal tunnel inlet using high-resolution ultrasonography. Values are recorded in square millimeters (mm²). Higher cross-sectional area values indicate greater nerve swelling and worse pathological status.'}, {'measure': 'Clinical Signs Assessed by Tinel and Phalen Tests', 'timeFrame': 'Baseline (Week 0), Week 3, Month 1, Month 3', 'description': 'The presence or absence of positive Tinel and Phalen signs will be recorded. A positive test indicates median nerve irritation. A reduction in the proportion of positive tests indicates clinical improvement.'}], 'secondaryOutcomes': [{'measure': 'Sleep Quality Assessed by Pittsburgh Sleep Quality Index', 'timeFrame': 'Baseline (Week 0), Week 3, Month 1, Month 3', 'description': 'Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. The total global score ranges from 0 to 21. Higher scores indicate poorer sleep quality and worse outcome.'}, {'measure': 'Patient Satisfaction Assessed by 5-Point Likert Scale', 'timeFrame': 'Week 3 (End of Treatment)', 'description': 'Patient satisfaction will be assessed using a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction and better perceived treatment outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['median nerve compression', 'carpal tunnel syndrome(cts)', 'magnetotherapy'], 'conditions': ['Magnetotherapy', 'Carpal Tunnel Syndrome (CTS)', 'Median Nerve Compression']}, 'descriptionModule': {'briefSummary': 'This study is designed to investigate the effectiveness of low-frequency pulsed electromagnetic field therapy in individuals diagnosed with mild-to-moderate carpal tunnel syndrome (CTS). This double-blind, randomized controlled trial will randomly assign participants into three groups:\n\nGroup 1: Active magnetotherapy\n\nGroup 2: Placebo magnetotherapy (treatment using an identical device that does not generate a magnetic field)\n\nGroup 3: Routine (conservative) treatment group\n\nAll participants will receive a standard nighttime wrist splint and a standardized nerve and tendon gliding exercise protocol. Magnetic field applications will be administered five days per week for a total of 15 sessions. Assessments will be conducted at baseline (T0), at the end of treatment (T1 - Week 3), at 1 month (T2), and at 3 months (T3).\n\nThe primary outcome measures include the Boston Carpal Tunnel Questionnaire (BCTQ), pain intensity assessed by the Visual Analog Scale (VAS), functional status measured by QuickDASH, median nerve cross-sectional area assessed by ultrasonography, sensory function evaluated using the Semmes-Weinstein monofilament test, grip strength measured by dynamometry, and clinical test results (Tinel and Phalen tests). Secondary outcomes include sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI) and patient satisfaction.\n\nThis study aims to contribute to the scientific evidence regarding the effectiveness of magnetotherapy as a non-invasive treatment option for carpal tunnel syndrome.', 'detailedDescription': 'Carpal tunnel syndrome (CTS) is a common entrapment neuropathy caused by compression of the median nerve within the carpal tunnel at the wrist, resulting in symptoms such as tingling, numbness, pain, and functional impairment in the hand and fingers. According to the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM), the diagnosis is supported electrophysiologically by delayed distal motor or sensory conduction, conduction block, or prolonged response latency of the median nerve. Clinically, CTS presents with paresthesia, pain, numbness, and functional limitations. The condition is more prevalent among middle-aged individuals, particularly office workers, homemakers, and those engaged in repetitive wrist movements. If left untreated, CTS may lead to muscle weakness and a significant decline in quality of life.\n\nConservative treatment options include nighttime wrist splinting, nerve mobilization exercises, pharmacological therapy, and physical therapy modalities. However, these approaches are generally symptom-oriented and may have limited long-term effectiveness.\n\nMagnetotherapy has emerged as a non-invasive physical therapy modality with minimal side effects. Pulsed electromagnetic field (PEMF) therapy has been reported to reduce pain and improve objective nerve function in refractory CTS cases in both short- and long-term follow-up. Nevertheless, scientific evidence regarding the effectiveness of magnetotherapy in CTS remains limited, and many existing studies lack robust methodological designs such as placebo control, randomization, and blinding. Therefore, this study aims to contribute to the current literature and strengthen clinical decision-making by providing high-quality evidence on the effectiveness of magnetotherapy in CTS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged between 18 and 65 years.\n\nClinical diagnosis of carpal tunnel syndrome (CTS) based on physical examination findings, including positive Tinel and/or Phalen tests and hypoesthesia in the 3rd to 5th digits.\n\nElectrophysiologically confirmed mild-to-moderate carpal tunnel syndrome based on electromyography (EMG) findings.\n\nExclusion Criteria:\n\n* Severe carpal tunnel syndrome confirmed electrophysiologically by electromyography (EMG).\n\nHistory of previous surgical intervention for carpal tunnel syndrome.\n\nPresence of other peripheral nerve entrapments (e.g., ulnar nerve entrapment, radial nerve entrapment).\n\nElectrophysiologically confirmed polyneuropathy or cervical radiculopathy/cervical discopathy.\n\nRheumatologic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus).\n\nDiabetes mellitus (Type 1 or Type 2).\n\nPregnancy.\n\nPresence of electronic implants such as cardiac pacemaker, cochlear implant, or implantable defibrillator.\n\nActive acute infection.\n\nHistory of malignancy.\n\nReceipt of physical therapy or rehabilitation for the wrist or surrounding area within the past 6 months.\n\nCorticosteroid injection to the wrist within the past 6 months.\n\nHyperthyroidism or adrenal gland hyperfunction.\n\nOpen growth plates (epiphyseal plates not closed).\n\nParoxysmal neurological disorders (e.g., epilepsy).\n\nMyasthenia gravis.\n\nRegular use of pain medications such as pregabalin, duloxetine, or non-steroidal anti-inflammatory drugs (NSAIDs).'}, 'identificationModule': {'nctId': 'NCT07435961', 'briefTitle': 'Magnetotherapy in Carpal Tunnel Syndrome: Randomized Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Fatih Sultan Mehmet Training and Research Hospital'}, 'officialTitle': 'Evaluation of the Effectiveness of Magnetotherapy in Patients With Carpal Tunnel Syndrome: A Placebo-Controlled, Triple-Arm, Randomized, Double-Blind Study', 'orgStudyIdInfo': {'id': 'CTS-MGNT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 (Magnetotherapy Group):', 'description': 'Participants will receive pulsed magnetotherapy five days per week for a total of 15 sessions. Treatment parameters will be 50 Hz frequency, 2-3 mT magnetic field intensity, and 15-20 minutes per session. In addition, participants in this group will use a standard nighttime wrist splint and follow a standardized home exercise program consisting of nerve and tendon gliding exercises.', 'interventionNames': ['Device: Arm 1: Active Magnetotherapy Group']}, {'type': 'SHAM_COMPARATOR', 'label': 'Group 2 (Placebo Magnetotherapy Group)', 'description': 'Participants will receive treatment using the same device, with identical appearance and session duration; however, the device will not generate a magnetic field (sham mode). Participants in this group will also use a standard nighttime wrist splint and follow the same standardized home exercise program (nerve and tendon gliding exercises).', 'interventionNames': ['Device: Arm 2: Sham (Placebo) Magnetotherapy Group']}, {'type': 'OTHER', 'label': 'Group 3 (Routine/Conservative Treatment Group)', 'description': 'Participants in this group will use a standard nighttime wrist splint and follow the standardized home exercise program (nerve and tendon gliding exercises). These participants will be placed on a wait-list for magnetotherapy.', 'interventionNames': ['Other: Arm 3: Conservative Treatment (Wait-List Control) Group']}], 'interventions': [{'name': 'Arm 1: Active Magnetotherapy Group', 'type': 'DEVICE', 'description': 'Participants assigned to this group will receive active pulsed electromagnetic field (PEMF) therapy administered five days per week for three consecutive weeks, totaling 15 treatment sessions. Each session will last 15-20 minutes. The treatment will be delivered using a clinically approved medical device set at a frequency of 50 Hz and a magnetic field intensity of 2-3 millitesla (mT). The application will be performed in a controlled clinical setting by trained healthcare personnel.\n\nIn addition to magnetotherapy, all participants in this group will receive standard conservative treatment, including the use of a neutral-position wrist splint during nighttime and a standardized home-based exercise program consisting of nerve gliding and tendon gliding exercises. Participants will be instructed on proper exercise performance and adherence will be monitored throughout the study period.', 'armGroupLabels': ['Group 1 (Magnetotherapy Group):']}, {'name': 'Arm 2: Sham (Placebo) Magnetotherapy Group', 'type': 'DEVICE', 'description': 'Participants in this group will undergo a sham magnetotherapy procedure using the same device, with identical appearance, positioning, session duration, and application protocol as the active treatment group. However, the device will be set to a mode that does not generate a magnetic field. This approach is designed to maintain participant blinding and control for placebo effects.\n\nSimilar to the active group, participants will receive standard conservative treatment consisting of nighttime wrist splint use and the same standardized nerve and tendon gliding home exercise program. Exercise instructions and compliance monitoring will be identical to those of the active treatment group.', 'armGroupLabels': ['Group 2 (Placebo Magnetotherapy Group)']}, {'name': 'Arm 3: Conservative Treatment (Wait-List Control) Group', 'type': 'OTHER', 'description': 'Participants in this group will receive standard conservative management only, including nighttime wrist splinting and the standardized home-based nerve and tendon gliding exercise program. No magnetotherapy device will be applied during the study period.\n\nTo ensure ethical considerations, participants in this group will be placed on a wait-list and may be offered magnetotherapy after completion of the follow-up assessments. Compliance with splint use and exercise performance will be monitored similarly to the other groups.', 'armGroupLabels': ['Group 3 (Routine/Conservative Treatment Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34734', 'city': 'Istanbul', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Orçun Ünalan, medical doctor', 'role': 'CONTACT', 'email': 'orcununalan@gmail.com', 'phone': '+905337335856'}, {'name': 'Orçun Ünalan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pınar Akpınar, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Fatih Sultan Mehmet Research and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Orçun Ünalan, medical doctor', 'role': 'CONTACT', 'email': 'orcununalan@gmail.com', 'phone': '+905337335856'}, {'name': 'Pınar Akpınar, medical doctor', 'role': 'CONTACT', 'email': 'pinar.pinarakpinar@gmail.com', 'phone': '+905057877442'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared publicly. All collected data will be de-identified and analyzed for scientific publication purposes only.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatih Sultan Mehmet Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor', 'investigatorFullName': 'Orçun Ünalan', 'investigatorAffiliation': 'Fatih Sultan Mehmet Training and Research Hospital'}}}}