[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653309":3},{"organization":4,"outcomesModule":7,"designInfo":63,"detailedDescription":73,"studyPopulation":62,"armGroups":74,"interventions":92,"overallOfficials":62,"centralContacts":62,"locations":105,"responsibleParty":129,"collaborators":62,"id":133,"slug":134,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":62,"eligibilityCriteria":139,"healthyVolunteers":135,"sex":140,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":62,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":108,"whyStopped":62,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"Istanbul Medipol University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":62},[9],{"measure":10,"description":11,"timeFrame":12},"Neck Disability Index","A self-reported questionnaire used to measure neck pain-related functional disability. It consists of 10 items, each scored from 0 to 5, with a total score ranging from 0 to 50. Higher scores indicate greater disability.","Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)",[14,18,21,24,27,30,33,36,39,42,45,48,51,54,58],{"measure":15,"description":16,"timeFrame":17},"Numeric Pain Rating Scale (NPRS)","A 11-point numeric scale used to measure neck pain intensity, ranging from 0 (no pain) to 10 (worst intensity of pain imaginable). Higher scores indicate greater pain intensity.","Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2).",{"measure":19,"description":20,"timeFrame":12},"Cervical Range of Motion (CROM)","Neck flexion, extension, right\u002Fleft lateral flexion, and right\u002Fleft rotation will be measured in degrees using the Clinometer smartphone app. Higher values indicate a greater range of motion.",{"measure":22,"description":23,"timeFrame":12},"Flexion-Rotation Test (FRT)","Upper cervical spine rotation mobility (C1-C2 segment) will be evaluated in degrees using the Clinometer smartphone application during passive cervical flexion. Higher degrees will represent better upper cervical mobility.",{"measure":25,"description":26,"timeFrame":12},"Cervical Joint Position Error (JPE)","Cervical proprioceptive accuracy will be assessed by measuring the re-positioning error degree from active rotation to the neutral head position using a laser pointer attached to a headband at a 90 cm distance. Lower degrees will indicate better proprioceptive accuracy.",{"measure":28,"description":29,"timeFrame":12},"Pressure Pain Threshold (PPT)","Local and widespread pain sensitivity will be measured in kg\u002Fcm² using a digital algometer (JTECH) over the upper trapezius, sternocleidomastoid, and tibialis anterior muscles. Higher values will indicate higher pain thresholds (less sensitivity).",{"measure":31,"description":32,"timeFrame":12},"Deep Neck Flexor and Extensor Muscle Endurance","Isometric muscle endurance will be assessed in seconds for deep neck flexors (supine position with craniocervical flexion) and neck extensors (prone position). Higher holding times will indicate superior muscle endurance.",{"measure":34,"description":35,"timeFrame":12},"Patient-Specific Functional Scale (PSFS)","Participants will identify 3 to 5 important activities restricted by neck pain and rate each from 0 (unable to perform) to 10 (able to perform at pre-injury level). Total score will be averaged, with higher scores indicating better functional ability.",{"measure":37,"description":38,"timeFrame":12},"36-Item Short Form Health Survey (SF-36)","Health-related quality of life will be evaluated across 8 domains, yielding scores from 0 to 100 for each subscale. Higher scores will represent better health status and quality of life.",{"measure":40,"description":41,"timeFrame":12},"Tampa Scale for Kinesiophobia (TSK)","Fear of movement and (re)injury will be assessed using a 17-item questionnaire with total scores ranging from 17 to 68. Higher scores will indicate greater kinesiophobia.",{"measure":43,"description":44,"timeFrame":12},"Pain Catastrophizing Scale (PCS)","Exaggerated negative thoughts about pain will be evaluated using a 13-item instrument across subscales of helplessness, rumination, and magnification. Total scores will range from 0 to 52, with higher scores indicating higher catastrophic thinking.",{"measure":46,"description":47,"timeFrame":12},"Central Sensitization Inventory (CSI)","Central sensitization symptoms will be assessed using a 25-item self-report questionnaire scored from 0 to 100. Higher scores will indicate greater central sensitization severity, with a cutoff score of 40 representing clinical central sensitization.",{"measure":49,"description":50,"timeFrame":12},"Fear-Avoidance Beliefs Questionnaire (FABQ)","Fear-avoidance beliefs regarding physical activity (subscale 0-24) and work (subscale 0-42) will be evaluated using a 16-item scale. Higher scores will reflect stronger fear-avoidance beliefs.",{"measure":52,"description":53,"timeFrame":12},"Hospital Anxiety and Depression Scale (HADS)","Anxiety (HADS-A, 7 items) and depression (HADS-D, 7 items) levels will be assessed using a 14-item questionnaire. Each subscale will be scored from 0 to 21, with higher scores indicating greater emotional distress.",{"measure":55,"description":56,"timeFrame":57},"Global Rating of Change (GRC)","Patient-perceived overall change in neck condition will be assessed using a single-item 15-point Likert scale ranging from -7 (a great deal worse) to +7 (a great deal better).","8 weeks (post-intervention, T1) and 12 weeks (4-week follow-up, T2)",{"measure":59,"description":60,"timeFrame":61},"Treatment Compliance Rate","Treatment compliance will be assessed by recording the percentage of completed intervention sessions relative to the scheduled protocol, with a compliance rate over 80% defined as high adherence.","8 weeks (post-intervention, T1)",null,{"allocation":64,"interventionModel":65,"interventionModelDescription":66,"primaryPurpose":67,"observationalModel":62,"timePerspective":62,"maskingInfo":68},"RANDOMIZED","PARALLEL","A 1:1:1 parallel-group randomized controlled trial with three intervention arms: Structured Exercise Group, Sensorimotor Training Group, and Pain Neuroscience Education Group.","TREATMENT",{"masking":69,"maskingDescription":70,"whoMasked":71},"SINGLE","Due to the nature of the physical therapy interventions, participants and treating physiotherapists cannot be blinded to group allocation. However, outcome assessors, the independent researcher responsible for randomization, and the statistician conducting the data analysis will be strictly blinded to group assignments.",[72],"OUTCOMES_ASSESSOR","Background and Rationale:\n\nChronic non-specific neck pain (CNSNP) involves complex interactions between musculoskeletal, neurological, and psychosocial factors. Patients frequently experience reduced cervical mobility, impaired sensorimotor control (such as altered joint position sense), central sensitization, and psychological distress including kinesiophobia and pain catastrophizing. While clinical guidelines strongly recommend exercise therapy and patient education, the optimal combination of specific exercise modalities and neuroscience education remains unclear.\n\nStudy Design:\n\nThis study is designed as a prospective, single-blind, three-arm randomized controlled trial conducted at Istanbul Medipol University. Eligible participants will be stratified based on Central Sensitization Inventory (CSI) scores (\\\u003C40, 40-49, ≥50) and randomized using a 1:1:1 allocation ratio into three intervention arms via block randomization (block size of 6). Assesors and data statisticians will be blinded to group assignments.\n\nIntervention Protocols:\n\nStructured Exercise Group (SEG): Participants will receive 24 supervised sessions over 8 weeks (3 sessions\u002Fweek, \\~30 mins). Protocol includes cervical active ROM warming\u002Fcooling, stretching, progressive isometric and isotonic resistance exercises with elastic bands (monitored via Borg RPE scale), and craniocervical flexion stabilization exercises using a pressure biofeedback unit.\n\nSensorimotor Training Group (SMTG): Participants will undertake 24 supervised sessions over 8 weeks (3 sessions\u002Fweek, \\~30 mins). Exercises focus on joint position sense retraining using laser feedback, oculomotor control (smooth pursuit, gaze stability, eye-head coordination), and static\u002Fdynamic balance training under varied visual\u002Fsurface conditions.\n\nPain Neuroscience Education Group (PNEG): Participants will attend 10 online group sessions via Zoom over 8 weeks (\\~45 mins\u002Fsession). In addition to the pain neuroscience education curriculum covering pain neurophysiology, peripheral and central sensitization, neuroplasticity, descending inhibition, and cognitive modification, 1 session will be dedicated to demonstrating home-based neck exercises. Participants will be encouraged to perform home exercises 3 days a week for 10 minutes per session. While exercise engagement is encouraged as part of the education, no forced compliance or routine exercise reminders will be provided. Patient exercise diaries will be requested at the end of each month throughout the intervention period.\n\nOutcome Assessment:\n\nAll evaluations are performed at baseline (T0), post-treatment at week 8 (T1), and follow-up at week 12 (T2):\n\nPrimary Outcomes: Neck Disability Index (NDI) and Numeric Rating Pain Scale (NPRS) for pain intensity.\n\nSecondary Outcomes: Cervical Range of Motion (Clinometer app), Flexion-Rotation Test (FRT), Joint Position Error (JPE), Pressure Pain Threshold (JTECH digital algometer), Deep Neck Flexor\u002FExtensor Endurance, Patient-Specific Functional Scale (PSFS), Short Form 36 (SF-36), Tampa Scale for Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), Central Sensitization Inventory (CSI), Fear-Avoidance Beliefs Questionnaire (FABQ), Hospital Anxiety and Depression Scale (HADS), Global Rating of Change (GRC), and treatment compliance.",[75,81,87],{"label":76,"type":77,"description":78,"interventionNames":79},"Structured Exercise Group (SEG)","ACTIVE_COMPARATOR","Participants will receive a structured exercise program consisting of 24 supervised sessions over 8 weeks (3 sessions\u002Fweek, 30 mins\u002Fsession). The program includes active cervical ROM exercises and stretching for neck muscles. Resistance training involves progressive isometric and isotonic exercises using elastic bands monitored via Borg RPE scale. Cervical stabilization includes craniocervical flexion exercises using a pressure biofeedback unit.",[80],"Other: Structured Exercise Program",{"label":82,"type":83,"description":84,"interventionNames":85},"Sensorimotor Training Group (SMTG)","EXPERIMENTAL","Participants will receive sensorimotor training consisting of 24 supervised sessions over 8 weeks (3 sessions\u002Fweek, 30 mins\u002Fsession) following a 3-minute ROM warm-up. The protocol includes joint position sense retraining using laser feedback, oculomotor exercises (smooth pursuit, gaze stability, eye-head coordination), and static\u002Fdynamic balance training under varied visual conditions and support surfaces.",[86],"Other: Sensorimotor Training",{"label":88,"type":83,"description":89,"interventionNames":90},"Pain Neuroscience Education Group (PNEG)","Participants will receive online pain neuroscience education delivered in 10 group sessions via Zoom over 8 weeks (2 sessions in first 2 weeks 1, 1 session\u002Fweek thereafter, \\~45 mins\u002Fsession). In addition to the pain neuroscience education curriculum covering pain neurophysiology, peripheral and central sensitization, neuroplasticity, descending inhibition, and cognitive modification, 1 session will be dedicated to demonstrating home-based neck exercises. Participants will be encouraged to perform these home exercises 3 days a week for 10 minutes per session. While exercise engagement is encouraged as part of the education, no forced compliance or routine exercise reminders will be provided. Patient exercise diaries will be requested at the end of each month throughout the intervention period.",[91],"Other: Pain Neuroscience Education",[93,97,101],{"type":6,"name":94,"description":95,"armGroupLabels":96,"otherNames":62},"Structured Exercise Program","Participants will receive a structured exercise program consisting of 24 supervised sessions over 8 weeks (3 sessions\u002Fweek, 20-30 mins\u002Fsession). The program includes active cervical ROM exercises, stretching for neck muscles, progressive isometric\u002Fisotonic elastic band exercises monitored via Borg RPE scale, and craniocervical flexion stabilization using a pressure biofeedback unit.",[76],{"type":6,"name":98,"description":99,"armGroupLabels":100,"otherNames":62},"Sensorimotor Training","Participants will receive sensorimotor training consisting of 24 supervised sessions over 8 weeks (3 sessions\u002Fweek, 20-30 mins\u002Fsession) following a 3-minute ROM warm-up. The protocol includes joint position sense retraining using laser feedback, oculomotor exercises (smooth pursuit, gaze stability, eye-head coordination), and static\u002Fdynamic balance training under varied visual conditions and support surfaces.",[82],{"type":6,"name":102,"description":103,"armGroupLabels":104,"otherNames":62},"Pain Neuroscience Education","Participants will receive online pain neuroscience education delivered in 10 group sessions via Zoom over 8 weeks. In addition to the pain neuroscience education curriculum covering pain neurophysiology, peripheral and central sensitization, neuroplasticity, descending inhibition, and cognitive modification, 1 session will be dedicated to demonstrating home-based neck exercises. Participants will be encouraged to perform these home exercises 3 days a week for 10 minutes per session. While exercise engagement is encouraged as part of the education, no forced compliance or routine exercise reminders will be provided. Patient exercise diaries will be requested at the end of each month throughout the intervention period.",[88],[106],{"facility":107,"status":108,"city":109,"state":110,"zip":111,"country":112,"countryCode":62,"cosmosGeoPoint":113,"geoPoint":118,"contacts":119},"Istanbul Medipol University","RECRUITING","Istanbul","Beykoz","34820","Turkey (Türkiye)",{"type":114,"coordinates":115},"Point",[116,117],28.94966,41.01384,{"lat":117,"lon":116},[120,125],{"name":121,"role":122,"phone":123,"phoneExt":62,"email":124},"Sabiha Irem Sancaktar, M.Sc.","CONTACT","+905312403072","sancaktarsabihairem@gmail.com",{"name":126,"role":122,"phone":127,"phoneExt":62,"email":128},"Gizem Ergezen, Ph.D.","+905347098414","gergezen@medipol.edu.tr",{"type":130,"investigatorFullName":131,"investigatorTitle":132,"investigatorAffiliation":5,"oldNameTitle":62,"oldOrganization":62},"PRINCIPAL_INVESTIGATOR","sabiha sancaktar","MSc physiotherapist","100653309","effects-of-physiotherapy-approaches-on-biopsychosocial-outcomes-in-chronic-non-specific-neck-pain-100653309",false,"NCT07784504","Effects of Physiotherapy Approaches on Biopsychosocial Outcomes in Chronic Non-Specific Neck Pain","Investigation of the Effects of Different Physiotherapy Approaches on Biopsychosocial Outcomes in Chronic Non-Specific Neck Pain","Inclusion Criteria:\n\n* Diagnosis of chronic non-specific neck pain lasting for more than 90 days\n* Age between 18 and 65 years (inclusive)\n* History of receiving standard physical therapy in a clinical setting in Turkey, yet experiencing persistent neck pain\n* Numeric Pain Rating Scale (NPRS) score ≥ 3\u002F10 at rest and during active cervical movement\n* Neck Disability Index (NDI) score ≥ 5\u002F50\n* Voluntary agreement to participate and signing of the informed consent form\n\nExclusion Criteria:\n\n* Neck pain associated with nerve root involvement or radiculopathy\n* History of prior cervical spine surgery\n* Physical therapy interventions received within the last 3 months\n* Severe spinal pathologies (e.g., fracture, tumor, infection, structural instability)\n* Systemic conditions (e.g., rheumatic, neurological, metabolic diseases)\n* Presence of vertigo or sensory loss\n* History of cancer within the last 5 years","ALL","18 Years","65 Years",{"count":144,"type":145},66,"ESTIMATED","INTERVENTIONAL",[148],"NA","Chronic non-specific neck pain (CNSNP) is a widespread musculoskeletal condition leading to pain, disability, and impaired quality of life. Due to its multifactorial nature involving biomechanical, sensorimotor, and psychosocial aspects, various rehabilitation interventions have been recommended. However, there is a lack of direct evidence comparing structured exercise, sensorimotor training, and pain neuroscience education within a comprehensive biopsychosocial framework.\n\nThe primary objective of this randomized controlled trial is to evaluate and compare the effectiveness of structured exercise, sensorimotor training, and pain neuroscience education on disability, pain intensity, sensorimotor control, and psychosocial outcomes in individuals with CNSNP.\n\nParticipants aged 18-65 with chronic non-specific neck pain will be randomly allocated into three intervention groups:\n\nStructured Exercise Group (SEG): Cervical stabilization, isometric\u002Fisotonic exercises, stretching, and range of motion training.\n\nSensorimotor Training Group (SMTG): Cervical joint position sense retraining, oculomotor exercises, and balance training.\n\nPain Neuroscience Education Group (PNEG): Online educational sessions focused on pain neurophysiology, central sensitization, and cognitive-behavioral strategies.\n\nOutcomes will be assessed at baseline (T0), completion of 8 weeks of intervention (T1), and 4 weeks post-intervention follow-up (T2, 12th week).",[151],"Chronic Non-specific Neck Pain",[153,154,155,156],"sensorimotor exercise","neck pain","pain neuroscience education","structured exercise","2026-09-14",{"date":159,"type":160},"2026-09-15","ACTUAL",{"date":157,"type":160},{"date":163,"type":145},"2027-09-21",{"name":5,"class":6},1]