[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653562":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":51,"studyPopulation":51,"armGroups":63,"interventions":83,"overallOfficials":51,"centralContacts":108,"locations":114,"responsibleParty":127,"collaborators":51,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":51,"eligibilityCriteria":136,"healthyVolunteers":132,"sex":137,"minAge":138,"maxAge":51,"enrollmentInfo":139,"targetDuration":51,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":154,"whyStopped":51,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Bursa Yuksek Ihtisas Training and Research Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":51},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline in Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (SSS)","Symptom severity will be assessed using the Turkish-validated Symptom Severity Scale of the Boston Carpal Tunnel Questionnaire. Higher scores indicate greater symptom severity.\n\nUnit of Measure: score","Before treatment, immediately after completing 15 sessions, and 3 months after treatment completion",{"measure":14,"description":15,"timeFrame":12},"Change from Baseline in Boston Carpal Tunnel Questionnaire - Functional Status Scale (FSS)","Functional status will be assessed using the Turkish-validated Functional Status Scale of the Boston Carpal Tunnel Questionnaire. Higher scores indicate greater functional impairment.\n\nUnit of Measure: score",[17,21,24,27,30,33,36,39,42,45,48],{"measure":18,"description":19,"timeFrame":20},"Change from Baseline in Median Sensory Nerve Action Potential Amplitude","Assessed via median sensory nerve conduction study. Unit of Measure: microvolts (µV)","Before treatment and 3 months after treatment completion",{"measure":22,"description":23,"timeFrame":20},"Change from Baseline in Median Sensory Nerve Conduction Velocity","Assessed via median sensory nerve conduction study. Unit of Measure: meters\u002Fsecond (m\u002Fs)",{"measure":25,"description":26,"timeFrame":20},"Change from Baseline in Median Sensory Distal Latency","Assessed via median sensory nerve conduction study. Unit of Measure: milliseconds (ms)",{"measure":28,"description":29,"timeFrame":20},"Change from Baseline in Median Motor Compound Muscle Action Potential Amplitude","Assessed via median motor nerve conduction study. Unit of Measure: millivolts (mV)",{"measure":31,"description":32,"timeFrame":20},"Change from Baseline in Median Motor Nerve Conduction Velocity","Assessed via median motor nerve conduction study. Unit of Measure: meters\u002Fsecond (m\u002Fs)",{"measure":34,"description":35,"timeFrame":20},"Change from Baseline in Median Motor Distal Latency","Assessed via median motor nerve conduction study. Unit of Measure: milliseconds (ms)",{"measure":37,"description":38,"timeFrame":12},"Change from Baseline in Median Nerve Cross-Sectional Area (Ultrasonography)","Median nerve cross-sectional area, transverse diameters, intraneural vascularity, echogenicity, and palmar bowing will be assessed by ultrasonography.\n\nUnit of Measure: square millimeters (mm²)",{"measure":40,"description":41,"timeFrame":12},"Change from Baseline in Grip Strength","Assessed using a Jamar hydraulic hand dynamometer, following American Society of Hand Therapists (ASHT) recommendations. The mean of three trials will be used.\n\nUnit of Measure: kilograms (kg)",{"measure":43,"description":44,"timeFrame":12},"Change from Baseline in Pinch Strength (Tip, Tripod, and Tip-to-Tip Pinch)","Assessed using a pinch gauge for tip pinch (lateral pinch), tripod pinch (3-jaw chuck), and tip-to-tip pinch. The mean of three trials for each pinch type will be used.\n\nUnit of Measure: kilograms (kg)",{"measure":46,"description":47,"timeFrame":12},"Change from Baseline in Pain (Visual Analog Scale)","Pain intensity will be assessed using a 0-10 cm Visual Analog Scale, with higher scores indicating greater pain intensity.\n\nUnit of Measure: score on a scale (0-10)",{"measure":49,"description":50,"timeFrame":12},"Change from Baseline in QuickDASH Score","Upper extremity function will be assessed using the Turkish-validated QuickDASH questionnaire, with higher scores indicating greater disability.\n\nUnit of Measure: score on a scale (0-100)",null,{"allocation":53,"interventionModel":54,"interventionModelDescription":51,"primaryPurpose":55,"observationalModel":51,"timePerspective":51,"maskingInfo":56},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":57,"maskingDescription":58,"whoMasked":59},"TRIPLE","Clinical assessments, grip\u002Fpinch strength measurements, ultrasonographic examinations, and electrophysiological studies will be performed by assessors blinded to treatment allocation. Participants in the active LLLT and sham LLLT arms will be blinded to their allocation, as identical devices, application sites, and session durations will be used; however, full participant blinding across all three arms is not feasible due to the clearly distinguishable nature of paraffin bath therapy.",[60,61,62],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[64,71,77],{"label":65,"type":66,"description":67,"interventionNames":68},"Experimental: LLLT Group","EXPERIMENTAL","Participants in this arm will receive active low-level laser therapy in addition to standard conservative care (night wrist splinting and home exercise program).",[69,70],"Device: Low-Level Laser Therapy (LLLT)","Other: Standard Conservative Care",{"label":72,"type":73,"description":74,"interventionNames":75},"Active Comparator: Paraffin Group","ACTIVE_COMPARATOR","Participants in this arm will receive paraffin bath therapy in addition to standard conservative care (night wrist splinting and home exercise program).",[76,70],"Device: Paraffin Bath Therapy",{"label":78,"type":79,"description":80,"interventionNames":81},"Sham Comparator: Sham LLLT Group","SHAM_COMPARATOR","Participants in this arm will receive sham low-level laser therapy (identical device, duration, and application sites, without therapeutic energy output) in addition to standard conservative care (night wrist splinting and home exercise program).",[82,70],"Device: Sham Low-Level Laser Therapy",[84,91,97,103],{"type":85,"name":86,"description":87,"armGroupLabels":88,"otherNames":89},"DEVICE","Low-Level Laser Therapy (LLLT)","Active LLLT applied at 670 nm wavelength at 5 points along the carpal tunnel and flexor retinaculum at the wrist level, delivering 0.8 J per point (4 J per session), administered once daily, 5 days\u002Fweek, for 3 weeks (15 sessions total).\n\nArms assigned: Arm 1 (LLLT Group)",[65],[90],"BTL LLLT device",{"type":85,"name":92,"description":93,"armGroupLabels":94,"otherNames":95},"Paraffin Bath Therapy","The hand is dipped into a container of melted paraffin, removed, and the paraffin layer is left in place for approximately 20 minutes before being peeled off. Administered once daily, 5 days\u002Fweek, for 3 weeks (15 sessions total).\n\nArms assigned: Arm 2 (Paraffin Group)",[72],[96],"Zirvemed paraffin device",{"type":85,"name":98,"description":99,"armGroupLabels":100,"otherNames":101},"Sham Low-Level Laser Therapy","The same laser device, application sites, and session duration as active LLLT will be used, but without therapeutic energy output, administered once daily, 5 days\u002Fweek, for 3 weeks (15 sessions total).\n\nArms assigned: Arm 3 (Sham LLLT Group)",[78],[102],"Sham BTL LLLT device",{"type":104,"name":105,"description":106,"armGroupLabels":107,"otherNames":51},"OTHER","Standard Conservative Care","All participants will continue a home exercise program consisting of tendon and median nerve gliding exercises, along with regular use of a night wrist splint, from enrollment until the final study assessment.\n\nArms assigned: Arm 1, Arm 2, Arm 3 (all arms)",[72,65,78],[109],{"name":110,"role":111,"phone":112,"phoneExt":51,"email":113},"Sinem Akselim","CONTACT","+905336391332","sinemakselim@gmail.com",[115],{"facility":116,"status":51,"city":117,"state":51,"zip":51,"country":118,"countryCode":51,"cosmosGeoPoint":119,"geoPoint":124,"contacts":125},"University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital","Bursa","Turkey (Türkiye)",{"type":120,"coordinates":121},"Point",[122,123],29.06013,40.19559,{"lat":123,"lon":122},[126],{"name":110,"role":111,"phone":112,"phoneExt":51,"email":113},{"type":128,"investigatorFullName":110,"investigatorTitle":129,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"PRINCIPAL_INVESTIGATOR","Principle investigator","100653562","low-level-laser-therapy-for-carpal-tunnel-syndrome-100653562",false,"NCT07788248","Low-Level Laser Therapy for Carpal Tunnel Syndrome","Efficacy of Low-Level Laser Therapy on Symptom Severity, Functionality, Ultrasonographic and Electrophysiological Parameters in Carpal Tunnel Syndrome: A Randomized, Sham-Controlled, Assessor-Blind Trial","Inclusion Criteria:\n\n* Diagnosis of mild-to-moderate carpal tunnel syndrome (unilateral or bilateral), confirmed by paresthesia and pain in the median nerve distribution, positive Tinel's and Phalen's signs on physical examination, and electrophysiologically confirmed mild-to-moderate CTS\n* Age 18 years or older\n* No cognitive impairment\n* Provision of informed consent to participate in the study\n\nExclusion Criteria:\n\n* Cognitive impairment\n* Severe-stage CTS with surgery planned\n* Neurological disease affecting the extremity with CTS\n* Active local infection at the treatment site (e.g., cellulitis, erysipelas, thrombophlebitis) contraindicating physical therapy\n* Cardiac pacemaker (contraindication to physical therapy and electrodiagnostic studies)\n* Prior wrist fracture or laceration at the treatment site\n* Injection therapy for CTS within the past 3 months\n* Prior CTS surgery with recurrence\n* Active malignancy under treatment\n* Pregnancy","ALL","18 Years",{"count":140,"type":141},105,"ESTIMATED","INTERVENTIONAL",[144],"NA","Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy, caused by compression of the median nerve within the carpal tunnel at the wrist. It typically presents with paresthesia, numbness, and pain in the median nerve distribution, and in advanced cases may lead to thenar atrophy and reduced grip strength. Conservative treatment options for mild-to-moderate CTS include wrist splinting, exercise programs, and physical therapy modalities such as low-level laser therapy (LLLT) and paraffin bath therapy; however, the comparative efficacy of these modalities has not been well established.\n\nThis study aims to compare the efficacy of low-level laser therapy (LLLT), paraffin bath therapy, and sham LLLT, each combined with standard conservative care (night wrist splinting and tendon\u002Fnerve gliding exercises), in patients with mild-to-moderate CTS. Participants will be randomly assigned in a 1:1:1 ratio to receive LLLT, paraffin bath therapy, or sham LLLT, each administered 5 days\u002Fweek for 3 weeks (15 sessions), in addition to wrist splinting and a home exercise program continued throughout the study.\n\nThe primary outcome is the change in symptom severity and functional status, assessed using the Symptom Severity Scale (SSS) and Functional Status Scale (FSS) of the Boston Carpal Tunnel Questionnaire. Secondary outcomes include electrophysiological parameters from median nerve conduction studies, median nerve cross-sectional area on ultrasonography, grip and pinch strength, pain (Visual Analog Scale), and hand function (QuickDASH). Assessments will be performed before treatment, immediately after completing 15 sessions, and at 3 months after treatment completion. Outcome assessors will be blinded to treatment allocation.\n\nThe investigators hypothesize that LLLT will result in greater improvement in clinical, electrophysiological, and morphological parameters compared with sham LLLT, and will provide comparative data on its efficacy relative to paraffin bath therapy.",[147],"Carpal Tunnel Syndrome (CTS)",[149,150,151,152,153],"Low-level laser therapy","Carpal tunnel syndrome","Paraffin bath therapy","median nerve ultrasonography","median nerve conduction study","NOT_YET_RECRUITING","2026-08-22",{"date":157,"type":158},"2026-08-26","ACTUAL",{"date":160,"type":141},"2026-09-01",{"date":162,"type":141},"2027-02-01",{"name":5,"class":6},1]