Effects of Physiotherapy Approaches on Biopsychosocial Outcomes in Chronic Non-Specific Neck Pain | NCT07784504 | Trialant

Not yet recruitingInterventionalNot ApplicableUpdated Aug 25, 2026

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

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07784504
Lead Sponsor: Istanbul Medipol University HospitalOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 66Estimated
Last Update Posted: Aug 25, 2026Actual
Start Date: Sep 14, 2026Estimated
Primary Completion Date: Sep 14, 2027Estimated
Completion Date: Sep 21, 2027Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

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

The medical conditions and diseases this study investigates.

Chronic Non-specific Neck Pain

Interventions

The treatments and procedures being evaluated in this study.

Structured Exercise Program
Sensorimotor Training
Pain Neuroscience Education

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Locations

Where the study is run and whether each site is currently recruiting.

Istanbul Medipol University

Istanbul, Beykoz 34820, Turkey (Türkiye)

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Istanbul Medipol University HospitalOTHER

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Other registered studies that closely resemble this one.

Detailed Description

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.