Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:28 PM
Study NCT ID:
NCT07414069
Status:
RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Intensity Laser Therapy in Carpal Tunnel Syndrome: Clinical, Sonographic, and Electrophysiological Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D002607', 'term': 'Charcot-Marie-Tooth Disease'}], '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': 'D015417', 'term': 'Hereditary Sensory and Motor Neuropathy'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to one of two parallel groups: a High-Intensity Laser Therapy (HILT) group or a sham HILT group. Both groups will receive standard wrist splinting as part of conservative management. Outcomes will be assessed and compared between groups at predefined time points.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-01-14', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Severity assessed by Visual Analog Scale (VAS)', 'timeFrame': 'At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.', 'description': 'Pain intensity will be evaluated using the Visual Analog Scale (VAS). This is a self-reported scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "severe pain". Higher scores indicate a worse outcome (greater pain intensity).'}, {'measure': 'Symptom Severity and Functional Status assessed by Boston Carpal Tunnel Questionnaire (BCTQ)', 'timeFrame': 'At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.', 'description': 'The BCTQ consists of two subscales: the Symptom Severity Scale (SSS) and the Functional Status Scale (FSS). The SSS has 11 items and the FSS has 8 items. Each item is scored on a scale from 1 to 5, where 1 indicates "no symptoms/no difficulty" and 5 indicates "severe symptoms/cannot perform activity". The final score is calculated as the mean of the items. Higher scores indicate a worse outcome (more severe symptoms and greater functional impairment).'}], 'secondaryOutcomes': [{'measure': 'Median Nerve Cross-Sectional Area(CSA)', 'timeFrame': 'At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period', 'description': 'The cross-sectional area of the median nerve will be measured by ultrasonography at the proximal carpal tunnel level. In Carpal Tunnel Syndrome (CTS), the nerve typically swells due to edema and inflammation. A decrease in the cross-sectional area indicates a positive response to treatment.\n\nUnit of Measure: Square millimeters (mm²) Interpretation: Lower values indicate a better clinical outcome (reduction in nerve edema).BE'}, {'measure': 'Hand Grip Strength', 'timeFrame': 'At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.', 'description': 'Evaluation of the maximum isometric strength of the hand and forearm muscles using a hydraulic hand dynamometer (Baseline® hydraulic LCD hand dynamometer). The measurement is performed with the patient seated, elbow flexed at 90 degrees and wrist in a neutral position. The average of three measurements is recorded.\n\nInterpretation: Higher scores indicate a better outcome. An increase in grip strength suggests improved muscular function and a reduction in the inhibitory effects of pain and nerve compression caused by Carpal Tunnel Syndrome.\n\nUnit of Measure: Kilograms (kg)'}, {'measure': 'Pinch Strength (Lateral Pinch)', 'timeFrame': 'Time Frame: At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.', 'description': 'Description: Evaluation of the strength of the pinch between the thumb and the index finger using a hydraulic pinch gauge (Baseline® hydraulic LCD pinch gauge). Lateral pinch is measured by asking the patient to press between the pad of the thumb and the lateral aspect of the index finger.\n\nInterpretation: Higher scores indicate a better outcome. Improved pinch strength reflects better coordination and strength of the intrinsic hand muscles innervated by the median nerve.\n\nUnit of Measure: Kilograms (kg)'}, {'measure': 'Median Nerve Motor Distal Latency (MDL)', 'timeFrame': 'At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.', 'description': 'Evaluation of the motor component of the median nerve using an Electroneuromyography (ENMG) device (Nihon Kohden Neuropack 2).\n\nMDL reflects the time taken for an electrical impulse to travel from the wrist to the thenar muscle.\n\nUnit of Measure: Milliseconds (ms) Interpretation: Lower scores (shorter latency) indicate a better outcome. A decrease in latency suggests improved nerve conduction across the carpal tunnel, reflecting a reduction in nerve compression.'}, {'measure': 'Median Nerve Compound Muscle Action Potential (CMAP) Amplitude', 'timeFrame': 'At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.', 'description': 'Measurement of the motor action potential amplitude, reflecting the integrity of the motor axons and neuromuscular junctions.\n\nUnit of Measure: Millivolts (mV) Interpretation: Higher amplitudes indicate a better outcome. An increase in amplitude suggests better motor axon recruitment and improved neuromuscular function.'}, {'measure': 'Median Nerve Sensory Conduction Velocity (Palmar)', 'timeFrame': 'At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.', 'description': 'Description: Measurement of the sensory conduction speed of the median nerve in the palmar segment (palm-to-wrist). This segment is often more sensitive to early compression within the carpal tunnel.\n\nInterpretation: Higher scores (faster velocity) indicate a better outcome. An increase in velocity indicates improved nerve function in the specific segment where compression is most prominent.\n\nUnit of Measure: Meters per second (m/s)'}, {'measure': 'Median Nerve Sensory Conduction Velocity (SCV)(Digit 2)', 'timeFrame': 'At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.', 'description': 'Description: Evaluation of the sensory conduction speed of the median nerve recorded from the 2nd digit to the wrist. It measures how fast electrical impulses travel through the distal part of the nerve.\n\nInterpretation: Higher scores (faster velocity) indicate a better outcome. An increase in velocity suggests that the sensory fibers of the median nerve are recovering and conducting signals more efficiently.\n\nUnit of Measure: Meters per second (m/s)'}, {'measure': 'Median Nerve Sensory Action Potential (SNAP) Amplitude (Palmar)', 'timeFrame': 'At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.', 'description': 'Description: Peak-to-peak measurement of the electrical response of the median nerve sensory fibers, recorded from the palmar segment to the wrist.\n\nInterpretation: Higher amplitudes indicate a better outcome. An increase in palmar SNAP amplitude indicates a recovery in the number of sensory fibers successfully conducting through the carpal tunnel.\n\nUnit of Measure: Microvolts (µV)'}, {'measure': 'Median Nerve Sensory Action Potential (SNAP) Amplitude (Digit 2)', 'timeFrame': 'At baseline (pre-treatment), and at 1 and 3 months following the conclusion of the 2-week treatment period.', 'description': 'Description: Peak-to-peak measurement of the electrical response of the median nerve sensory fibers, recorded from the 2nd digit.\n\nInterpretation: Higher amplitudes indicate a better outcome. Increased amplitude reflects a greater number of healthy, functioning sensory axons and improved nerve integrity.\n\nUnit of Measure: Microvolts (µV)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carpal Tunnel Syndrome', 'High-Intensity Laser Therapy', 'HILT', 'Entrapment Neuropathy', 'Median Nerve'], 'conditions': ['Carpal Tunnel Syndrome']}, 'referencesModule': {'references': [{'pmid': '37906312', 'type': 'BACKGROUND', 'citation': 'Yigit F, Ordahan B. Effects of high-intensity laser therapy on pain, functional status, hand grip strength, and median nerve cross-sectional area by ultrasonography in patients with carpal tunnel syndrome. Lasers Med Sci. 2023 Oct 31;38(1):248. doi: 10.1007/s10103-023-03913-z.'}, {'pmid': '40121869', 'type': 'BACKGROUND', 'citation': 'de la Barra Ortiz HA, Avila MA, Parizotto NA, Liebano RE. A systematic review and meta-analysis of the effectiveness of high-intensity laser therapy in patients with carpal tunnel syndrome. Physiotherapy. 2025 Sep;128:101780. doi: 10.1016/j.physio.2025.101780. Epub 2025 Mar 5.'}]}, 'descriptionModule': {'briefSummary': 'Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper extremity and is characterized by pain, paresthesia, and functional impairment resulting from increased pressure within the carpal tunnel. Although conservative treatment approaches such as splinting and pharmacological therapy are commonly used, High-Intensity Laser Therapy (HILT) has emerged as a non-invasive modality with potential analgesic, anti-inflammatory, and biostimulatory effects. However, evidence regarding its efficacy remains limited, particularly from sham-controlled studies incorporating objective outcome measures. This prospective, randomized, double-blind, sham-controlled clinical trial aims to evaluate the clinical, sonographic, and electrophysiological effectiveness of HILT in patients with mild-to-moderate CTS. Eligible patients aged 18 to 65 years with electrophysiologically confirmed mild-to-moderate CTS will be randomized into two groups: a HILT group and a sham HILT group. Both groups will receive standard wrist splinting as part of conservative management. Clinical outcomes will be assessed using Visual Analog Scale (VAS) scores for pain, Boston Carpal Tunnel Questionnaire (BCTQ) scores for symptom severity and functional status, and grip strength measurements. Objective evaluations will include median nerve sensory and motor nerve conduction studies and ultrasonographic measurement of the median nerve cross-sectional area at the proximal carpal tunnel level. Assessments will be performed at baseline and at 1 and 3 months after treatment. This study aims to provide robust and objective evidence regarding the therapeutic effectiveness of HILT in the conservative management of carpal tunnel syndrome.', 'detailedDescription': 'Carpal Tunnel Syndrome (CTS) is the most common entrapment neuropathy of the upper extremity, characterized by the compression of the median nerve due to increased pressure within the carpal tunnel. While conservative management strategies such as splinting and physical therapy modalities are the standard approach, High-Intensity Laser Therapy (HILT) has recently emerged as a potent, non-invasive therapeutic option . Utilizing an Nd:YAG laser source, HILT penetrates deep tissues to induce photochemical and photothermal effects. It is hypothesized to promote tissue repair by increasing ATP synthesis at the mitochondrial level, regulating Na/K pump activity, and providing analgesia by suppressing inflammatory mediators .\n\nAlthough HILT is used in clinical practice, there is a scarcity of sham-controlled, double-blind studies that comprehensively evaluate its efficacy using a combination of clinical, electrophysiological, and ultrasonographic (median nerve cross-sectional area) parameters .\n\nStudy Objective: The primary objective of this prospective, randomized, double-blind, sham-controlled trial is to provide evidence-based data on the efficacy of HILT regarding pain, hand function, grip strength, nerve conduction velocities, and median nerve morphology (ultrasonographic cross-sectional area) in patients with mild-to-moderate CTS.\n\nStudy Population and Design: Patients aged 18-65 years presenting to the Physical Therapy Clinic with clinically and electrophysiologically confirmed 80 patient hand mild-to-moderate CTS will be recruited.\n\nOutcome Measures and Timeline: Assessments will be performed by independent blinded researchers at Baseline, Month 1, and Month 3 post-treatment.\n\n* Clinical Assessment: Pain intensity (Visual Analog Scale - VAS), symptom severity and functional status (Boston Carpal Tunnel Questionnaire - BCTQ), gross grip strength (Hand Dynamometer), and pinch strength (Pinchmeter) .\n* Ultrasonographic Assessment: Measurement of the median nerve Cross-Sectional Area (CSA) at the proximal carpal tunnel inlet.\n* Electrophysiological Assessment: Sensory and motor nerve conduction studies of the median nerve (evaluating distal latency, conduction velocity, and amplitude).\n\nThis study aims to demonstrate the multifaceted contribution (clinical, anatomical, and physiological) of HILT to nerve recovery by reducing edema and inflammation in the pathophysiology of CTS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Clinical symptoms consistent with carpal tunnel syndrome\n* Electrophysiologically confirmed mild or moderate carpal tunnel syndrome\n* Ability to comply with the study protocol and follow-up assessments\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Severe carpal tunnel syndrome on electrophysiological examination\n* Previous surgical treatment for carpal tunnel syndrome\n* Local causes of carpal tunnel syndrome (e.g., mass lesions, ganglion cysts, tumors)\n* Systemic conditions associated with carpal tunnel syndrome (e.g., diabetes mellitus, hypothyroidism, pregnancy, acromegaly)\n* History of corticosteroid injection for carpal tunnel syndrome within the last 6 months\n* Presence of polyneuropathy, radiculopathy, or other upper extremity peripheral nerve disorders\n* Contraindications to electrophysiological testing or laser therapy\n* Inability to complete follow-up assessments'}, 'identificationModule': {'nctId': 'NCT07414069', 'briefTitle': 'High-Intensity Laser Therapy in Carpal Tunnel Syndrome: Clinical, Sonographic, and Electrophysiological Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Evaluation of the Clinical, Sonographic, and Electrophysiological Efficacy of High-Intensity Laser Therapy (HILT) in Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': '1-24-647'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-Intensity Laser Therapy (HILT)', 'description': 'Patients in this group will receive High-Intensity Laser Therapy (HILT) in addition to using a neutral wrist splint. The treatment will consist of a total of 10 sessions, administered 5 days per week for a duration of 2 weeks.', 'interventionNames': ['Device: High-Intensity Laser Therapy (HILT)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham High-Intensity Laser Therapy', 'description': 'Patients in this group will receive sham (placebo) laser therapy in addition to using a neutral wrist splint. The treatment will consist of a total of 10 sessions, administered 5 days per week for a duration of 2 weeks.', 'interventionNames': ['Device: Sham High-Intensity Laser Therapy']}], 'interventions': [{'name': 'High-Intensity Laser Therapy (HILT)', 'type': 'DEVICE', 'description': "Procedure: The laser is applied to the carpal tunnel area while the patient's forearm is in supination.\n\nDevice Specifications: Pulsed Nd:YAG laser source with Peak Power \\>3000 W, Intensity (max) 15,000 W/cm², Frequency 10-30 Hz, Pulse duration ≤ 100 μs, and a spot size of 0.5 cm diameter (0.2 cm²).\n\nTreatment Protocol (3 Phases):\n\n1. Initial Rapid Scan (3 Steps):\n\n Step 1: 25 Hz, 510 mJ/cm², 139 J energy.\n\n Step 2: 20 Hz, 610 mJ/cm², 139 J energy.\n\n Step 3: 19 Hz, 710 mJ/cm², 139 J energy.\n2. Trigger Point Phase: Applied to painful points on the affected side.\n\n Step 1: 15 Hz, 360 mJ/cm², 6.3 J energy.\n\n Step 2: 15 Hz, 510 mJ/cm², 9 J energy.\n\n Step 3: 14 Hz, 610 mJ/cm², 10.1 J energy (applied for 6 seconds per point).\n3. Final Slow Scan: Performed using the same parameters as the rapid scan phase.\n\nTotal Energy: A total of 835 Joules is delivered per session.", 'armGroupLabels': ['High-Intensity Laser Therapy (HILT)']}, {'name': 'Sham High-Intensity Laser Therapy', 'type': 'DEVICE', 'description': 'The same HIRO TT device is used with the same positioning and duration as the experimental group. The device provides auditory and visual cues identical to the active treatment, but no laser energy is emitted to the tissue. Participants will also use a standard wrist splint.', 'armGroupLabels': ['Sham High-Intensity Laser Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'state': 'Ankara, Çankaya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Filiz Eser', 'role': 'CONTACT', 'email': 'filizeser@gmail.com', 'phone': '+905067388171'}], 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Ceren FINDIK KILIÇ', 'role': 'CONTACT', 'email': 'crn.fndk@gmail.com', 'phone': '+905312689928'}], 'overallOfficials': [{'name': 'Filiz Eser, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital Bilkent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}