NCT07781982

Brief Summary

Cervical disc herniation is a common degenerative spinal disorder associated with chronic neck pain, impaired cervical function, reduced motor control, and decreased quality of life. Although conventional physiotherapy is widely used, innovative rehabilitation strategies that enhance motor learning may improve treatment outcomes. This randomized controlled trial aims to investigate the clinical effectiveness of Action Observation (AO) and Motor Imagery (MI) training as an adjunct to conventional physiotherapy in individuals with cervical disc herniation and chronic neck pain. Thirty-six participants diagnosed with cervical disc herniation will be randomly assigned to one of two groups. The control group will receive conventional physiotherapy combined with sham observation consisting of neutral nature videos, while the experimental group will receive conventional physiotherapy plus AO and MI training. The intervention period will last six weeks. Clinical outcomes will be assessed before and after the intervention. Primary and secondary outcome measures will include pain intensity, pressure pain threshold, neck disability, kinesiophobia, cervical motor control and endurance, and cervical proprioception using validated assessment tools. The findings of this study are expected to provide evidence regarding the effectiveness of AO and MI training as complementary rehabilitation approaches for individuals with cervical disc herniation and to support the integration of motor learning-based interventions into clinical physiotherapy practice.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Aug 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Aug 2026Dec 2026

First Submitted

Initial submission to the registry

August 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

August 25, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

August 19, 2026

Last Update Submit

August 19, 2026

Conditions

Keywords

Cervical disc herniationMotor imageryAction observationchronic painkinesiophobiafunction

Outcome Measures

Primary Outcomes (2)

  • Neck Disability Index

    Neck-related disability will be assessed using the Neck Disability Index (NDI). The NDI consists of 10 items addressing pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each item is scored from 0 to 5, resulting in a total score ranging from 0 to 50. Higher scores indicate greater neck-related disability.

    Baseline and immediately after the 6-week intervention

  • Craniocervical Flexion Test

    Deep cervical flexor motor control and endurance will be assessed using the Craniocervical Flexion Test with a pressure biofeedback unit. Participants will perform progressive craniocervical flexion at five pressure levels (22-30 mmHg) from a baseline pressure of 20 mmHg. The highest pressure level successfully achieved and maintained for 10 seconds without compensatory movement will be recorded as the motor control performance. The participant's ability to sustain the target pressure level throughout the test will also be used to evaluate deep cervical flexor muscle endurance. Higher performance reflects better motor control and endurance.

    Baseline and immediately after the 6-week intervention

Secondary Outcomes (4)

  • Visual Analog Scale for Pain

    Baseline and immediately after the 6-week intervention

  • Pressure Pain Threshold Measured With a Digital Algometer

    Baseline and immediately after the 6-week intervention

  • Tampa Scale for Kinesiophobia-11

    Baseline and immediately after the 6-week intervention

  • Cervical Joint Position Error

    Baseline and immediately after the 6-week intervention

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants in the experimental group will receive an individualized conventional physiotherapy program three times per week for six weeks. In addition, they will receive approximately 20 minutes of Action Observation (AO) and Motor Imagery (MI) training during each treatment session.

Other: Conventional PhysiotherapyOther: Action Observation and Motor Imagery Training

Control Group

SHAM COMPARATOR

Participants in the control group will receive the same individualized conventional physiotherapy program three times per week for six weeks. In place of Action Observation and Motor Imagery training, they will watch neutral nature videos without motor content for approximately 20 minutes during each session as a sham observation intervention.

Other: Conventional PhysiotherapyOther: Sham Observation

Interventions

Participants in both study groups will receive an individualized conventional physiotherapy program three times per week for six weeks. The program will include electrotherapy (conventional transcutaneous electrical nerve stimulation or vacuum interferential current applied on alternating sessions), superficial heat therapy, soft tissue mobilization, and a supervised therapeutic exercise program. The exercise program will consist of deep cervical flexor activation exercises, cervical range-of-motion exercises, scapular stabilization exercises, postural correction exercises, and stretching exercises targeting the upper trapezius, levator scapulae, and pectoral muscles. All treatment sessions will be delivered individually by the same physiotherapist, and exercise intensity will be adjusted according to each participant's tolerance and clinical status.

Control GroupExperimental Group

Participants in the experimental group will receive approximately 20 minutes of Action Observation (AO) and Motor Imagery (MI) training in addition to conventional physiotherapy during each treatment session, three times per week for six weeks. During the AO component, participants will observe standardized videos demonstrating correct execution of cervical and scapular movements, including cervical flexion, extension, lateral flexion, rotation, and scapular retraction. Immediately afterward, participants will perform MI under physiotherapist supervision by mentally rehearsing the same movements using both visual imagery (imagining observing themselves performing the movement) and kinesthetic imagery (imagining the sensory experience of performing the movement). All sessions will be delivered individually following a standardized intervention protocol.

Experimental Group

Participants in the control group will receive approximately 20 minutes of sham observation in addition to conventional physiotherapy during each treatment session, three times per week for six weeks. Instead of Action Observation and Motor Imagery training, participants will watch neutral nature videos without any human movement or motor-related content. The sham intervention is designed to match the experimental intervention in duration, therapist supervision, and attention while avoiding activation of motor learning processes.

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 to 65 years. Diagnosis of cervical radiculopathy confirmed by a physician based on clinical examination and magnetic resonance imaging (MRI).
  • History of chronic neck pain lasting at least 3 months. Sufficient active cervical range of motion to participate in the intervention (flexion and extension ≥20°, lateral flexion ≥15°, and rotation ≥30°).
  • Neck pain intensity of ≥3 points on the Visual Analog Scale (VAS) and neck disability of ≥10 points on the Neck Disability Index (NDI) at baseline.
  • Willingness to participate and provision of written informed consent.

You may not qualify if:

  • Inability to comply with the study protocol or cooperate with study procedures. Cognitive impairment (e.g., dementia or learning disability) that would interfere with understanding or completing the intervention or assessments.
  • History of cervical spine surgery. Acute trauma, fracture, tumor, infection, or other serious pathology involving the cervical spine or shoulder region.
  • Cervical spinal stenosis, cervical myelopathy, advanced cervical spondylosis, or other significant structural degenerative cervical spine disorders.
  • Uncontrolled neurological or systemic disease that could influence study participation or outcomes.
  • Receipt of any treatment targeting the cervical region within the previous 6 months (e.g., physiotherapy, injection therapy, or other invasive interventions).
  • Visual impairment, hearing impairment, or severe vestibular disorders that would prevent participation in the intervention protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic PainKinesiophobiaNeck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • İrem Çetinkaya, PhD

    Marmara University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

İrem Çetinkaya, PhD

CONTACT

Dilan Yaman

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 19, 2026

First Posted

August 24, 2026

Study Start

August 25, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 24, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share