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NCT Number: NCT07784504

Effects of Physiotherapy Approaches on Biopsychosocial Outcomes in Chronic Non-Specific Neck Pain

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Beykoz, 34820, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of chronic non-specific neck pain lasting for more than 90 days
  • Age between 18 and 65 years (inclusive)
  • History of receiving standard physical therapy in a clinical setting in Turkey, yet experiencing persistent neck pain
  • Numeric Pain Rating Scale (NPRS) score ≥ 3/10 at rest and during active cervical movement
  • Neck Disability Index (NDI) score ≥ 5/50
  • Voluntary agreement to participate and signing of the informed consent form

Exclusion criteria

  • Neck pain associated with nerve root involvement or radiculopathy
  • History of prior cervical spine surgery
  • Physical therapy interventions received within the last 3 months
  • Severe spinal pathologies (e.g., fracture, tumor, infection, structural instability)
  • Systemic conditions (e.g., rheumatic, neurological, metabolic diseases)
  • Presence of vertigo or sensory loss
  • History of cancer within the last 5 years

Treatment and study plan

Structured Exercise program

Other

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.

Sensorimotor Training

Other

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.

Pain neuroscience education

Other

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.

Primary outcomes

  1. Neck Disability Index

    Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)

    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.

Secondary outcomes

  1. Numeric Pain Rating Scale (NPRS)

    Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2).

    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.

  2. Cervical Range of Motion (CROM)

    Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)

    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.

  3. Flexion-Rotation Test (FRT)

    Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)

    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.

  4. Cervical Joint Position Error (JPE)

    Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)

    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.

  5. Pressure Pain Threshold (PPT)

    Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)

    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).

  6. Deep Neck Flexor and Extensor Muscle Endurance

    Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)

    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.

  7. Patient-Specific Functional Scale (PSFS)

    Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)

    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.

  8. 36-Item Short Form Health Survey (SF-36)

    Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)

    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.

  9. Tampa Scale for Kinesiophobia (TSK)

    Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)

    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.

  10. Pain Catastrophizing Scale (PCS)

    Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)

    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.

  11. Central Sensitization Inventory (CSI)

    Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)

    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.

  12. Fear-Avoidance Beliefs Questionnaire (FABQ)

    Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)

    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.

  13. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline (T0), 8 weeks (post-intervention, T1), and 12 weeks (4-week follow-up, T2)

    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.

  14. Global Rating of Change (GRC)

    Time frame: 8 weeks (post-intervention, T1) and 12 weeks (4-week follow-up, T2)

    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).

  15. Treatment Compliance Rate

    Time frame: 8 weeks (post-intervention, T1)

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Investigation of the Effects of Different Physiotherapy Approaches on Biopsychosocial Outcomes in Chronic Non-Specific Neck Pain

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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