An interventional study of Structured Exercise Program and Sensorimotor Training in Chronic Non-specific Neck Pain, sponsored by Istanbul Medipol University Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment
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.
The 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.
Participants aged 18-65 with chronic non-specific neck pain will be randomly allocated into three intervention groups:
Structured Exercise Group (SEG): Cervical stabilization, isometric/isotonic exercises, stretching, and range of motion training.
Sensorimotor Training Group (SMTG): Cervical joint position sense retraining, oculomotor exercises, and balance training.
Pain Neuroscience Education Group (PNEG): Online educational sessions focused on pain neurophysiology, central sensitization, and cognitive-behavioral strategies.
Outcomes will be assessed at baseline (T0), completion of 8 weeks of intervention (T1), and 4 weeks post-intervention follow-up (T2, 12th week).
Background and Rationale:
Chronic 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.
Study Design:
This 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 (\<40, 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.
Intervention Protocols:
Structured Exercise Group (SEG): Participants will receive 24 supervised sessions over 8 weeks (3 sessions/week, \~30 mins). Protocol includes cervical active ROM warming/cooling, 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.
Sensorimotor Training Group (SMTG): Participants will undertake 24 supervised sessions over 8 weeks (3 sessions/week, \~30 mins). Exercises focus on joint position sense retraining using laser feedback, oculomotor control (smooth pursuit, gaze stability, eye-head coordination), and static/dynamic balance training under varied visual/surface conditions.
Pain Neuroscience Education Group (PNEG): Participants will attend 10 online group sessions via Zoom over 8 weeks (\~45 mins/session). 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.
Outcome Assessment:
All evaluations are performed at baseline (T0), post-treatment at week 8 (T1), and follow-up at week 12 (T2):
Primary Outcomes: Neck Disability Index (NDI) and Numeric Rating Pain Scale (NPRS) for pain intensity.
Secondary Outcomes: Cervical Range of Motion (Clinometer app), Flexion-Rotation Test (FRT), Joint Position Error (JPE), Pressure Pain Threshold (JTECH digital algometer), Deep Neck Flexor/Extensor 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.
1,360 studies on the registry are indexed under Neck Pain; 299 are open to participants now.
This study's planned enrollment of 66 is above the median of 50 across 1,116 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →Istanbul Medipol University Hospital is the lead sponsor of 366 studies on the registry; 46 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a structured exercise program consisting of 24 supervised sessions over 8 weeks (3 sessions/week, 30 mins/session). 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.
Other: Structured Exercise Program
Participants will receive sensorimotor training consisting of 24 supervised sessions over 8 weeks (3 sessions/week, 30 mins/session) 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/dynamic balance training under varied visual conditions and support surfaces.
Other: Sensorimotor Training
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/week thereafter, \~45 mins/session). 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.
Other: Pain Neuroscience Education
Participants will receive a structured exercise program consisting of 24 supervised sessions over 8 weeks (3 sessions/week, 20-30 mins/session). The program includes active cervical ROM exercises, stretching for neck muscles, progressive isometric/isotonic elastic band exercises monitored via Borg RPE scale, and craniocervical flexion stabilization using a pressure biofeedback unit.
Participants will receive sensorimotor training consisting of 24 supervised sessions over 8 weeks (3 sessions/week, 20-30 mins/session) 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/dynamic balance training under varied visual conditions and support surfaces.
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.
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.
Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)
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.
Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2).
Cervical Range of Motion (CROM)
Neck flexion, extension, right/left lateral flexion, and right/left rotation will be measured in degrees using the Clinometer smartphone app. Higher values indicate a greater range of motion.
Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)
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.
Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)
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.
Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)
Pressure Pain Threshold (PPT)
Local and widespread pain sensitivity will be measured in kg/cm² using a digital algometer (JTECH) over the upper trapezius, sternocleidomastoid, and tibialis anterior muscles. Higher values will indicate higher pain thresholds (less sensitivity).
Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)
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.
Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)
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.
Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)
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.
Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)
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.
Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)
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.
Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)
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.
Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)
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.
Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)
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.
Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)
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).
Time frame: 8 weeks (post-intervention, T1) and 12 weeks (4-week follow-up, T2)
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.
Time frame: 8 weeks (post-intervention, T1)
Plan to share: Yes — De-identified individual participant data will be made available upon reasonable request from qualified researchers, subject to approval by the principal investigator and institutional review board.
Supporting information: Study protocol, Informed consent form
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