NCT06679335

Brief Summary

In this study, it was planned to investigate the effectiveness of lateralization and imagery training in individuals with chronic neck pain. A total of 34 individuals, 17 with chronic neck pain and 17 healthy individuals between the ages of 18-65, will be included in the study. Individuals in each group will be treated with lateralization and imagery training for 4 weeks. Before treatment, individuals' cognitive states will be evaluated with neuropsychological tests (Montreal Cognitive Assessment, Stroop test). Then, after completing the Motor Imagery Evaluation, Neck Pain Task Force Scale, Pain Severity, Kinesiophobia Evaluation, Neck Disability Evaluation, Proprioception Sense Test, Body Awareness Evaluation (Fremantle Neck Awareness Questionnaire) and Evaluation of Compliance with the Treatment Program, EEG recording of the individuals will be performed. EEG recording will be performed and analyzed with Spontaneous EEG, Oddball Paradigm and Lateralization paradigm. After four weeks of treatment, all pre-treatment tests will be repeated and then the individuals will be taken again for EEG recording. Brain oscillations will be examined through EEG analysis before and after treatment, and the extent to which brain activities have changed and the possible effect of the treatment on brain activities will be investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

December 16, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

June 12, 2024

Last Update Submit

December 8, 2025

Conditions

Keywords

Chronic Neck PainLateralization Imagery TrainingEEG Brain OscillationsProprioceptionBody Awareness

Outcome Measures

Primary Outcomes (9)

  • Cognitive Status Assessment (Montreal Cognitive Assessment: MoCA)

    It will be used to evaluate the cognitive status of individuals and to exclude participants from the study. It is a test that aims to evaluate participants in 7 cognitive aspects such as attention, concentration, memory, language, calculation, spatial-visual skills, reasoning and orientation. It takes approximately ten minutes. The highest score that can be obtained from the test is 30. The cognitive level of the participant who scores 21 points or above is considered normal. Turkish validity-reliability study was conducted by Özdilek and Kenangil in 2014.

    Baseline

  • Stroop test (quick)

    It is a cognitive control test consisting of three parts developed by J. R. Stroop in 1935. The Stroop task and related tests are considered the gold standard of attention measurements in the literature. In the first part of the test, subjects are presented with color names and asked to read them as quickly as possible. In the second part, you are asked to say the colors of dot clusters printed with colored ink as quickly as possible. In the third part, the students are asked to read the words written in ink of a different color than the name of the presented color as quickly (and loudly) as possible. The Turkish validity and reliability study was conducted by Karakaş et al. in 1999.

    Baseline, and up to 4 weeks

  • Motor Imagery Assessment

    Made using the Movement Imagery Questionnaire-3. The Turkish validity and reliability study of the questionnaire was conducted by Dilek et al. It was made by. It consists of 3 subscales and a total of 12 items that evaluate external visual imagery, internal visual imagery, and kinesthetic imagery. Each of the 12 tasks in the survey is first performed physically, then the participant returns to the starting position and imagery is performed according to the desired type of imagery. Scoring is made between 1 and 7, with "1 point: very difficult to see/feel, 7 points: very easy to see/feel." When calculating the score, internal visual imagery, external visual imagery and kinesthetic imagery scores are added separately, divided by 4 and averaged to obtain the score of each subscale.

    Baseline

  • Pain Intensity

    Individuals' pain intensity will be evaluated subjectively with the Visual Analog Scale (VAS). This scale consists of a 10 cm linear line. The starting point of the line is 0, no pain; The endpoint of 10 is the worst pain ever experienced in life; 5 indicates moderate pain. People will be asked to numerically rate the severity of their pain on the scale.

    Baseline, and up to 4 weeks

  • Kinesiophobia Assessment

    Fear of movement will be evaluated with the TAMPA kinesiophobia scale (TKÖ). TAS is a questionnaire consisting of 17 questions developed by Korietal in 1991 for musculoskeletal pain. This scale includes parameters for injury/re-injury and fear avoidance in activities related to . In this scale, each question was scored as (1 = disagree, 4 = strongly agree). While scoring, items 4, 8, 12 and 16 are reversed and then the total score is obtained. The person receives a total score between 17-68. The Turkish reliability of the Tampa Kinesiophobia Scale was conducted by Yılmaz et al.

    Baseline, and up to 4 weeks

  • Evaluation of Neck Disability

    The extent to which individuals' chronic neck pain affects their daily living activities will be evaluated with the Neck Disability Index (NEI). The Turkish validity and reliability of the index was determined by Telci et al. The index, which evaluates subjective symptoms and activities of daily living, consists of a total of 10 sections (pain intensity, personal care, lifting, reading, headache, concentration, work life, driving, sleep and leisure activities). There are 6 options for each section, ranging from 0 to 5 points. The total score varies between 0 and 50 (0: no disability; 50: maximum disability), and an increase in the total score indicates that the disability increases. In the evaluation in our study, the percentage of each score will be calculated to obtain an equal score distribution in case the patients do not answer some questions. 8 percent and below is considered "no excuse".

    Baseline, and up to 4 weeks

  • Proprioception Sense Test

    Cervical joint position error will be measured using the Dualer IQ digital inclinometer (J-Tech Medical, Midvale, UT, USA). Digital inclinometer spine assessment protocols are well established and approved by the American Medical Association. Digital inclinometer allows clinicians to evaluate range of motion and proprioception using dynamic inclinometry similar to that used in other goniometric protocols. Digital inclinometer has demonstrated test-retest reliability for measuring spinal range of motion.

    Baseline, and up to 4 weeks

  • Body Awareness Assessment

    Individuals' neck awareness will be assessed with the Fremantle Neck Awareness Questionnaire. Developed by Benedict Wand, its Turkish validity and reliability were confirmed by Onan et al. Likert type assessing individual-specific altered perception (0 = I never/never feel like this, 1= I rarely feel like this, 2 = Sometimes, or some of the time I feel like this, 3 = I often feel like this, 4 = I always or most of the time feel like this) It is a simple survey. The survey asks individuals 9 questions, such as how they perceive their neck in relation to their body and how they perceive their body position.

    Baseline, and up to 4 weeks

  • EEG power in alpha, theta, beta band

    Evaluation of brain oscillations with EEG analysis.

    Baseline, and up to 4 weeks

Study Arms (2)

Neck Pain Patients

EXPERIMENTAL
Other: Lateralization Imagery Training

Healty Controls

ACTIVE COMPARATOR
Other: Lateralization Imagery Training

Interventions

Lateralization Imagery Training (LIE) is a form of implicit motor imagery that involves determining as accurately and quickly as possible whether an image of a body part belongs to the left or right side. It has been assumed that LIE performance differences reflect changes in central nervous system functioning, errors in judgment, and changes in bodily representations. It has been shown that LIE is a complex mental task that includes cognitive, sensory, motor and behavioral processes and can be associated with them. A study showed that there was a strong correlation between LIE and proprioception. Within the scope of our study, 3 weeks of training will be provided; Lateralization imagery training will be given every day for the first 2 weeks, and imagery training will be given 3 days a week in the 2nd and 3rd weeks. A total of 20 sessions of treatment will be applied, including 14 sessions of lateralization and 6 sessions of visualization training.

Healty ControlsNeck Pain Patients

Eligibility Criteria

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

You may qualify if:

  • Between the ages of 18-65, having neck pain lasting more than 3 months,
  • Speaks and understands the Turkish language at a sufficient level,
  • Able to use telephone and computer,
  • Being literate,
  • Scored 21 or more on the Montreal Cognitive Assessment (MoCA) scale, which evaluates the cognitive status of individuals,
  • Reporting pain intensity as 30 mm or more on the Visual Analogue Scale (VAS),
  • Individuals with level 3 according to the Neck Pain Task Force Scale will be included.
  • Asymptomatic between the ages of 18-65,
  • Individuals matched with the study group in terms of body mass index and age
  • Do not feel neck or back pain that prevents them from normal activities,
  • Those who have not previously received medical intervention or treatment for their neck problem,
  • Being literate,
  • Individuals who score 21 or above on the Montreal Cognitive Assessment (MoCA) scale, which evaluates the cognitive status of individuals, will be included.

You may not qualify if:

  • Have received physiotherapy treatment due to neck pain in the last 6 months,
  • Those who have had neck surgery,
  • Suspicion of malignant or systemic disease,
  • Having a neurological disease or injury,
  • Individuals with vertigo, nausea, visual disturbances will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahcesehir Universty

Istanbul, BESIKTAS, 34353, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Chronic PainNeck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Özlem Ülger, Prof

    Hacettepe University

    STUDY DIRECTOR
  • Bahar Güntekin, Prof

    Medipol University

    STUDY DIRECTOR
  • Ayşenur Zaim, Master (Canditate)

    Medipol University

    PRINCIPAL INVESTIGATOR
  • Ayşegül Bostan, PhD (Candidate)

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Both healthy and neck patient groups will receive the training for 4 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 12, 2024

First Posted

November 7, 2024

Study Start

December 16, 2024

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

December 9, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations