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

NCT07784504 | Not Yet Recruiting

• 1 other identifier: IstanbulMUH-FTR-SIS-02
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chronic Non-specific Neck Pain

Keywords

sensorimotor exercise; neck pain; pain neuroscience education; structured exercise

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (15)

• Numeric Pain Rating Scale (NPRS)

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

• Cervical Range of Motion (CROM)

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

• Flexion-Rotation Test (FRT)

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

• Cervical Joint Position Error (JPE)

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

• Pressure Pain Threshold (PPT)

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

Study Arms (3)

Structured Exercise Group (SEG)

ACTIVE COMPARATOR

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

Sensorimotor Training Group (SMTG)

EXPERIMENTAL

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

Pain Neuroscience Education Group (PNEG)

EXPERIMENTAL

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

Interventions

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.

Structured Exercise Group (SEG)

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.

Sensorimotor Training Group (SMTG)

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.

Pain Neuroscience Education Group (PNEG)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34820, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc physiotherapist

Model Details: A 1:1:1 parallel-group randomized controlled trial with three intervention arms: Structured Exercise Group, Sensorimotor Training Group, and Pain Neuroscience Education Group.

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): September 14, 2026
• Primary Completion (Estimated): September 14, 2027
• Study Completion (Estimated): September 21, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

TU (1)