Chronic PainNCT06679335
Examining the Effect of Lateralization Imagery Training on EEG Brain Oscillations in Individuals With Chronic Neck Pain
A study testing Lateralization Imagery Training in people with Chronic Pain and Neck Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Neck Pain
- What is being tested?
- Lateralization Imagery Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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),
Show all 14Show fewer
- Individuals with level 3 according to the Neck Pain Task Force Scale will be included.
- Inclusion criteria for healthy group / Asymptomatic Individuals
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahcesehir Universty
Istanbul, BESIKTAS, 34353
About this study
Official title: Examining the Effect of Lateralization Imagery Training on EEG Brain Oscillations, Pain Intensity, Proprioception, Kinesiophobia and Body Awareness in Individuals With Chronic Neck Pain
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.
Read the detailed description
Chronic neck pain is one of the debilitating conditions that can impair the ability to perform regular daily activities, reduce productivity, and negatively impact quality of life. Approximately two-thirds of people in developed countries experience neck pain. At any given time, approximately 14% to 16% of the adult population globally experiences neck pain, with an average lifetime prevalence of 48.5%. Chronic pain is categorized as pain that lasts more than three months.
It is very important to understand neuroplasticity to know how acute pain turns into chronic pain. Local inflammation of injured tissue increases the sensitivity of peripheral sensory neurons (nociceptors), resulting in recurrent abnormal afferent input to the central nervous system. Chronic pain causes abnormal cortical reorganization and abnormal neural circuit formation in subcortical structures through neuroplastic changes in the brain. Due to chronic pain; Deterioration in body schema perception, weaknesses in perceiving somatosensory differences, deterioration in movement quality and difficulties in performing complex movements occur. Cervical afferent input to the upper centers may change for these reasons, thus cervical proprioception may be impaired.
One of the main problems of patients with neck pain is that impairment of cervical proprioception leads to impairment of cervical sensorimotor control. A study revealed that the focus of studies should be on special programs that address different aspects of sensorimotor control disorders, such as training aimed at improving proprioception and muscle coordination.
Motor imagery (MI) approach is a method created to reduce pain and improve function, especially in chronic painful situations. It is known that imagination and active movement pass through and occur through similar neural pathways. In MI, it is seen that similar regions are activated during imagination in the same way that the regions that occur during real movement and are activated in the motor cortex. In this method, premotor cortex activation is achieved without primary motor cortex activation. Movement signals are produced in cortical areas before movement is performed.
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.
It has been shown that individuals with chronic pain have a decrease in their ability to distinguish right-left (extremity lateralization). Being able to distinguish right from left is related to one's ability to position one's body in space. With right-left discrimination training, the higher cortical functions of the right brain hemisphere, such as whole vision, visual skills and body schema perception, are reactivated and tried to be imparted to the individual.
In some patients with chronic pain, thinking about moving the painful extremity may cause overactivation of motor-related cerebral cortices, including the cingulate motor area (SMA) and primary motor cortex, which may aggravate the cognition associated with painful experiences. For these reasons, it is an issue that needs to be investigated what kind of changes occur in patients with chronic neck pain, especially in cognitive affect and cortex activities. Electroencephalography (EEG), a non-invasive technique, is one of the methods that measure activity in the cortex. To our knowledge, there is no study in the literature investigating the effects of lateralization imagery training on EEG brain oscillations, pain intensity, kinesiophobia and proprioception in individuals with chronic neck pain.
In the light of this information, the primary purpose of the study is to a) examine whether brain activity changes at the cortex level by measuring the electrical activities in the brain during lateralization imagery training (LIE) with EEG, and b) determine whether LIE affects the severity of neck pain and disability in individuals with chronic neck pain. The aim is to examine its effects on sensory acuity, proprioception, kinesiophobia and body awareness.
The secondary aim of this study is; To evaluate the relationship between pain intensity/disability and sensory acuity, proprioception, kinesiophobia and body awareness in individuals with chronic neck pain.
The hypotheses developed to achieve these goals are; Hypothesis 1. Lateralization imagery training has an effect on brain activities in individuals with chronic neck pain.
Hypothesis 2. Lateralization imagery training has an effect on pain intensity in individuals with chronic neck pain.
Hypothesis 3. Lateralization imagery training has an effect on disability in individuals with chronic neck pain.
Hypothesis 4. Lateralization imagery training has an effect on sensory acuity (two-point discrimination) in individuals with chronic neck pain.
Hypothesis 5. Lateralization imagery training has an effect on proprioception in individuals with chronic neck pain.
Hypothesis 6. Lateralization imagery training has an effect on kinesiophobia in individuals with chronic neck pain.
Hypothesis 5. Lateralization imagery training has an effect on body awareness in individuals with chronic neck pain.
Hypothesis 7. There is a relationship between the severity of neck pain and disability and sensory acuity, proprioception, kinesiophobia and body awareness in individuals with chronic neck pain.
Material and Method: Asymptomatic individuals with chronic neck pain will be included in the study. Individuals with chronic neck pain and asymptomatic individuals will be divided into two groups: study and control, in a randomized controlled manner. Both groups will receive 3-week lateralization imagery training; Lateralization imagery training will be given every day for the first 2 weeks, and in the 2nd and 3rd weeks, imagery training will be given 3 days a week in addition to LIE. A total of 20 sessions of treatment will be applied, including 14 sessions of lateralization and 6 sessions of visualization training.
The sample size was calculated using the G*Power 3.1.9.2 analysis program. A total sample size of 34 individuals, at least 17 for both groups, was estimated with 80% power, 0.08 alpha level and 0.8 effect size.
Working Group - Neck Pain Group
Individuals with chronic neck pain can see Specialist at FSM Medical Center. Dr. Emel Deniz Şahin will be included in the working group according to the inclusion and exclusion criteria. First, initial evaluations and all tests of the included individual will be performed by the physiotherapist. Secondly, individuals will be directed to the laboratory where EEG recording will be performed. Travel expenses of individuals will be covered by the physiotherapist.
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.
It will be done in 4 stages:
Stage 1: Information about the demographic and physical characteristics of the participants will be obtained. NPT, motor imagery assessment will be performed to determine compliance with inclusion criteria. Then, pain intensity, kinesiophobia, body awareness, disability evaluation, sensory acuity, proprioception sensory tests will be applied to the individual.
Stage 2: Individuals' spontaneous EEG recording will be performed, followed by the Oddball Paradigm and then the Lateralization Imagination Paradigm recording.
Stage 3: Individuals will be given 3 weeks of training. Lateralization imagery training will be given every day for the first 2 weeks, imagery training will begin in addition to LIE in the 2nd week, and will continue in the 3rd week. Imagery training will be 6 sessions in total, 3 days a week. A total of 20 sessions of treatment will be applied, including 14 sessions of lateralization and 6 sessions of visualization training. After LIE and imagery training is completed, individuals will be evaluated for pain, kinesiophobia, neck disability index, and Montreal cognitive evaluation. Two-point discrimination sensory test, muscle activation, and proprioceptive sensory tests will be repeated.
Stage 4: After the three-week LIE and imagery training and tests are completed, spontaneous EEG recording, Oddball Paradigm, and then Lateralization Imagination Paradigm will be repeated.
Healthy Group
According to the inclusion criteria, individuals will be included in the control group. Travel expenses of individuals will be covered by the physiotherapist.
It will be done in 4 stages:
Stage 1: Information about the demographic and physical characteristics of the participants will be obtained. NPT, motor imagery assessment will be performed to determine compliance with inclusion criteria. Then, pain intensity, kinesiophobia, body awareness, disability evaluation, sensory acuity, proprioception sensory tests will be applied to the individual.
Stage 2: Individuals' spontaneous EEG recording will be performed, followed by the Oddball Paradigm and then the Lateralization Imagination Paradigm recording.
Stage 3: Individuals will be given 3 weeks of training. Lateralization imagery training will be given every day for the first 2 weeks, imagery training will begin in addition to LIE in the 2nd week and will continue in the 3rd week. Imagery training will be 6 sessions in total, 3 days a week. A total of 20 sessions of treatment will be applied, including 14 sessions of lateralization and 6 sessions of visualization training. After LIE and imagery training is completed, individuals will be evaluated for pain, kinesiophobia, neck disability index, and Montreal cognitive evaluation. Two-point discrimination sensory test, muscle activation, and proprioceptive sensory tests will be repeated.
Stage 4: After the training and tests are completed, spontaneous EEG recording, Oddball Paradigm, and then Lateralization Imagination Paradigm will be repeated.
- Conditions
- Chronic Pain, Neck Pain
- Being tested
- Lateralization Imagery Training
- Keywords
- Chronic Neck Pain, Lateralization Imagery Training, EEG Brain Oscillations, Proprioception, Body Awareness
- Medical subject headings
- Chronic Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateralization Imagery TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Neck Pain Patients | Experimental | Not described Receives: Other: Lateralization Imagery Training |
| Healty Controls | Active comparator | Not described Receives: Other: Lateralization Imagery Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: Baseline, and up to 4 weeks
EEG power in alpha, theta, beta band
Evaluation of brain oscillations with EEG analysis.
Measured: Baseline, and up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start16 Dec 2024
- Primary completion1 Oct 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Both healthy and neck patient groups will receive the training for 4 weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegul Bostan, Bahçeşehir University
- Investigators
- Özlem Ülger, Prof, Study director, Hacettepe UniversityBahar Güntekin, Prof, Study director, Medipol UniversityAyşenur Zaim, Master (Canditate), Principal investigator, Medipol UniversityAyşegül Bostan, PhD (Candidate), Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679335
- Sponsor's protocol ID
- BAU-AYSEGULBOSTAN-001
- Status last verified
- Dec 2025
- First submitted
- 12 Jun 2024
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carvalho, R.Cd., Maglioni, C.B., Machado, G.B., Araújo, J.Ed., Silva, J.R.Td., Silva, M.Ld. 2018.
Genebra CVDS, Maciel NM, Bento TPF, Simeao SFAP, Vitta A. Prevalence and factors associated with neck pain: a population-based study. Braz J Phys Ther. 2017 Jul-Aug;21(4):274-280. doi: 10.1016/j.bjpt.2017.05.005. Epub 2017 May 20.
PubMed 28602744Hague M, Shenker N. How to investigate: Chronic pain. Best Pract Res Clin Rheumatol. 2014 Dec;28(6):860-74. doi: 10.1016/j.berh.2015.04.005. Epub 2015 May 23.
PubMed 26096090Brumagne S, Diers M, Danneels L, Moseley GL, Hodges PW. Neuroplasticity of Sensorimotor Control in Low Back Pain. J Orthop Sports Phys Ther. 2019 Jun;49(6):402-414. doi: 10.2519/jospt.2019.8489.
PubMed 31151373Yam MF, Loh YC, Tan CS, Khadijah Adam S, Abdul Manan N, Basir R. General Pathways of Pain Sensation and the Major Neurotransmitters Involved in Pain Regulation. Int J Mol Sci. 2018 Jul 24;19(8):2164. doi: 10.3390/ijms19082164.
PubMed 30042373Schwoebel J, Coslett HB, Bradt J, Friedman R, Dileo C. Pain and the body schema: effects of pain severity on mental representations of movement. Neurology. 2002 Sep 10;59(5):775-7. doi: 10.1212/wnl.59.5.775.
PubMed 12221179Reddy RS, Tedla JS, Dixit S, Abohashrh M. Cervical proprioception and its relationship with neck pain intensity in subjects with cervical spondylosis. BMC Musculoskelet Disord. 2019 Oct 15;20(1):447. doi: 10.1186/s12891-019-2846-z.
PubMed 31615495Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control. Man Ther. 2008 Feb;13(1):2-11. doi: 10.1016/j.math.2007.06.003. Epub 2007 Aug 16.
PubMed 17702636Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control--Part 2: case studies. Man Ther. 2008 Jun;13(3):266-75. doi: 10.1016/j.math.2007.11.002. Epub 2008 Jan 3.
PubMed 18180194Peng B, Yang L, Li Y, Liu T, Liu Y. Cervical Proprioception Impairment in Neck Pain-Pathophysiology, Clinical Evaluation, and Management: A Narrative Review. Pain Ther. 2021 Jun;10(1):143-164. doi: 10.1007/s40122-020-00230-z. Epub 2021 Jan 12.
PubMed 33464539Jeannerod, M. 1994. "The representing brain: Neural correlates of motor intention and imagery", Cambridge University Press, 187-202.
Hetu S, Gregoire M, Saimpont A, Coll MP, Eugene F, Michon PE, Jackson PL. The neural network of motor imagery: an ALE meta-analysis. Neurosci Biobehav Rev. 2013 Jun;37(5):930-49. doi: 10.1016/j.neubiorev.2013.03.017. Epub 2013 Apr 10.
PubMed 23583615Solodkin A, Hlustik P, Chen EE, Small SL. Fine modulation in network activation during motor execution and motor imagery. Cereb Cortex. 2004 Nov;14(11):1246-55. doi: 10.1093/cercor/bhh086. Epub 2004 May 27.
PubMed 15166100Osuagwu BA, Vuckovic A. Similarities between explicit and implicit motor imagery in mental rotation of hands: an EEG study. Neuropsychologia. 2014 Dec;65:197-210. doi: 10.1016/j.neuropsychologia.2014.10.029. Epub 2014 Oct 30.
PubMed 25446966Moseley, G.L. 2012. "The Graded Motor Imagery Handbook", Noigroup publications, Australia.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Lateralization Imagery Training on EEG Brain Oscillations, Pain Intensity, Proprioception, Kinesiophobia and Body Awareness in Individuals With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06679335
- Acronym / sponsor ID
- BAU-AYSEGULBOSTAN-001
- Conditions
- Chronic Pain, Neck Pain
- Keywords
- Chronic Neck Pain, Lateralization Imagery Training, EEG Brain Oscillations, Proprioception, Body Awareness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic neck pain is one of the debilitating conditions that can impair the ability to perform regular daily activities, reduce productivity, and negatively impact quality of life. Approximately two-thirds of people in developed countries experience neck pain. At any given time, approximately 14% to 16% of the adult population globally experiences neck pain, with an average lifetime prevalence of 48.5%. Chronic pain is categorized as pain that lasts more than three months.
It is very important to understand neuroplasticity to know how acute pain turns into chronic pain. Local inflammation of injured tissue increases the sensitivity of peripheral sensory neurons (nociceptors), resulting in recurrent abnormal afferent input to the central nervous system. Chronic pain causes abnormal cortical reorganization and abnormal neural circuit formation in subcortical structures through neuroplastic changes in the brain. Due to chronic pain; Deterioration in body schema perception, weaknesses in perceiving somatosensory differences, deterioration in movement quality and difficulties in performing complex movements occur. Cervical afferent input to the upper centers may change for these reasons, thus cervical proprioception may be impaired.
One of the main problems of patients with neck pain is that impairment of cervical proprioception leads to impairment of cervical sensorimotor control. A study revealed that the focus of studies should be on special programs that address different aspects of sensorimotor control disorders, such as training aimed at improving proprioception and muscle coordination.
Motor imagery (MI) approach is a method created to reduce pain and improve function, especially in chronic painful situations. It is known that imagination and active movement pass through and occur through similar neural pathways. In MI, it is seen that similar regions are activated during imagination in the same way that the regions that occur during real movement and are activated in the motor cortex. In this method, premotor cortex activation is achieved without primary motor cortex activation. Movement signals are produced in cortical areas before movement is performed.
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.
It has been shown that individuals with chronic pain have a decrease in their ability to distinguish right-left (extremity lateralization). Being able to distinguish right from left is related to one's ability to position one's body in space. With right-left discrimination training, the higher cortical functions of the right brain hemisphere, such as whole vision, visual skills and body schema perception, are reactivated and tried to be imparted to the individual.
In some patients with chronic pain, thinking about moving the painful extremity may cause overactivation of motor-related cerebral cortices, including the cingulate motor area (SMA) and primary motor cortex, which may aggravate the cognition associated with painful experiences. For these reasons, it is an issue that needs to be investigated what kind of changes occur in patients with chronic neck pain, especially in cognitive affect and cortex activities. Electroencephalography (EEG), a non-invasive technique, is one of the methods that measure activity in the cortex. To our knowledge, there is no study in the literature investigating the effects of lateralization imagery training on EEG brain oscillations, pain intensity, kinesiophobia and proprioception in individuals with chronic neck pain.
In the light of this information, the primary purpose of the study is to a) examine whether brain activity changes at the cortex level by measuring the electrical activities in the brain during lateralization imagery training (LIE) with EEG, and b) determine whether LIE affects the severity of neck pain and disability in individuals with chronic neck pain. The aim is to examine its effects on sensory acuity, proprioception, kinesiophobia and body awareness.
The secondary aim of this study is; To evaluate the relationship between pain intensity/disability and sensory acuity, proprioception, kinesiophobia and body awareness in individuals with chronic neck pain.
The hypotheses developed to achieve these goals are; Hypothesis 1. Lateralization imagery training has an effect on brain activities in individuals with chronic neck pain.
Hypothesis 2. Lateralization imagery training has an effect on pain intensity in individuals with chronic neck pain.
Hypothesis 3. Lateralization imagery training has an effect on disability in individuals with chronic neck pain.
Hypothesis 4. Lateralization imagery training has an effect on sensory acuity (two-point discrimination) in individuals with chronic neck pain.
Hypothesis 5. Lateralization imagery training has an effect on proprioception in individuals with chronic neck pain.
Hypothesis 6. Lateralization imagery training has an effect on kinesiophobia in individuals with chronic neck pain.
Hypothesis 5. Lateralization imagery training has an effect on body awareness in individuals with chronic neck pain.
Hypothesis 7. There is a relationship between the severity of neck pain and disability and sensory acuity, proprioception, kinesiophobia and body awareness in individuals with chronic neck pain.
Material and Method: Asymptomatic individuals with chronic neck pain will be included in the study. Individuals with chronic neck pain and asymptomatic individuals will be divided into two groups: study and control, in a randomized controlled manner. Both groups will receive 3-week lateralization imagery training; Lateralization imagery training will be given every day for the first 2 weeks, and in the 2nd and 3rd weeks, imagery training will be given 3 days a week in addition to LIE. A total of 20 sessions of treatment will be applied, including 14 sessions of lateralization and 6 sessions of visualization training.
The sample size was calculated using the G*Power 3.1.9.2 analysis program. A total sample size of 34 individuals, at least 17 for both groups, was estimated with 80% power, 0.08 alpha level and 0.8 effect size.
Working Group - Neck Pain Group
Individuals with chronic neck pain can see Specialist at FSM Medical Center. Dr. Emel Deniz Şahin will be included in the working group according to the inclusion and exclusion criteria. First, initial evaluations and all tests of the included individual will be performed by the physiotherapist. Secondly, individuals will be directed to the laboratory where EEG recording will be performed. Travel expenses of individuals will be covered by the physiotherapist.
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.
It will be done in 4 stages:
Stage 1: Information about the demographic and physical characteristics of the participants will be obtained. NPT, motor imagery assessment will be performed to determine compliance with inclusion criteria. Then, pain intensity, kinesiophobia, body awareness, disability evaluation, sensory acuity, proprioception sensory tests will be applied to the individual.
Stage 2: Individuals' spontaneous EEG recording will be performed, followed by the Oddball Paradigm and then the Lateralization Imagination Paradigm recording.
Stage 3: Individuals will be given 3 weeks of training. Lateralization imagery training will be given every day for the first 2 weeks, imagery training will begin in addition to LIE in the 2nd week, and will continue in the 3rd week. Imagery training will be 6 sessions in total, 3 days a week. A total of 20 sessions of treatment will be applied, including 14 sessions of lateralization and 6 sessions of visualization training. After LIE and imagery training is completed, individuals will be evaluated for pain, kinesiophobia, neck disability index, and Montreal cognitive evaluation. Two-point discrimination sensory test, muscle activation, and proprioceptive sensory tests will be repeated.
Stage 4: After the three-week LIE and imagery training and tests are completed, spontaneous EEG recording, Oddball Paradigm, and then Lateralization Imagination Paradigm will be repeated.
Healthy Group
According to the inclusion criteria, individuals will be included in the control group. Travel expenses of individuals will be covered by the physiotherapist.
It will be done in 4 stages:
Stage 1: Information about the demographic and physical characteristics of the participants will be obtained. NPT, motor imagery assessment will be performed to determine compliance with inclusion criteria. Then, pain intensity, kinesiophobia, body awareness, disability evaluation, sensory acuity, proprioception sensory tests will be applied to the individual.
Stage 2: Individuals' spontaneous EEG recording will be performed, followed by the Oddball Paradigm and then the Lateralization Imagination Paradigm recording.
Stage 3: Individuals will be given 3 weeks of training. Lateralization imagery training will be given every day for the first 2 weeks, imagery training will begin in addition to LIE in the 2nd week and will continue in the 3rd week. Imagery training will be 6 sessions in total, 3 days a week. A total of 20 sessions of treatment will be applied, including 14 sessions of lateralization and 6 sessions of visualization training. After LIE and imagery training is completed, individuals will be evaluated for pain, kinesiophobia, neck disability index, and Montreal cognitive evaluation. Two-point discrimination sensory test, muscle activation, and proprioceptive sensory tests will be repeated.
Stage 4: After the training and tests are completed, spontaneous EEG recording, Oddball Paradigm, and then Lateralization Imagination Paradigm will be repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Both healthy and neck patient groups will receive the training for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Neck Pain Patients | Experimental | Other: Lateralization Imagery Training |
| Healty Controls | Active comparator | Other: Lateralization Imagery Training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Inclusion criteria for healthy group / Asymptomatic Individuals
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateralization Imagery TrainingLateralization 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. | Other | Healty Controls, Neck Pain Patients |
Primary outcome
Cognitive Status Assessment (Montreal Cognitive Assessment: MoCA)
Time frame: Baseline
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.
Stroop test (quick)
Time frame: Baseline, and up to 4 weeks
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.
Motor Imagery Assessment
Time frame: Baseline
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.
Pain Intensity
Time frame: Baseline, and up to 4 weeks
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.
Kinesiophobia Assessment
Time frame: Baseline, and up to 4 weeks
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.
Evaluation of Neck Disability
Time frame: Baseline, and up to 4 weeks
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".
Proprioception Sense Test
Time frame: Baseline, and up to 4 weeks
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.
Body Awareness Assessment
Time frame: Baseline, and up to 4 weeks
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.
EEG power in alpha, theta, beta band
Time frame: Baseline, and up to 4 weeks
Evaluation of brain oscillations with EEG analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- BackgroundCarvalho, R.Cd., Maglioni, C.B., Machado, G.B., Araújo, J.Ed., Silva, J.R.Td., Silva, M.Ld. 2018.
- Background: PubMed 28602744Genebra CVDS, Maciel NM, Bento TPF, Simeao SFAP, Vitta A. Prevalence and factors associated with neck pain: a population-based study. Braz J Phys Ther. 2017 Jul-Aug;21(4):274-280. doi: 10.1016/j.bjpt.2017.05.005. Epub 2017 May 20.
- Background: PubMed 26096090Hague M, Shenker N. How to investigate: Chronic pain. Best Pract Res Clin Rheumatol. 2014 Dec;28(6):860-74. doi: 10.1016/j.berh.2015.04.005. Epub 2015 May 23.
- Background: PubMed 31151373Brumagne S, Diers M, Danneels L, Moseley GL, Hodges PW. Neuroplasticity of Sensorimotor Control in Low Back Pain. J Orthop Sports Phys Ther. 2019 Jun;49(6):402-414. doi: 10.2519/jospt.2019.8489.
- Background: PubMed 30042373Yam MF, Loh YC, Tan CS, Khadijah Adam S, Abdul Manan N, Basir R. General Pathways of Pain Sensation and the Major Neurotransmitters Involved in Pain Regulation. Int J Mol Sci. 2018 Jul 24;19(8):2164. doi: 10.3390/ijms19082164.
- Background: PubMed 12221179Schwoebel J, Coslett HB, Bradt J, Friedman R, Dileo C. Pain and the body schema: effects of pain severity on mental representations of movement. Neurology. 2002 Sep 10;59(5):775-7. doi: 10.1212/wnl.59.5.775.
- Background: PubMed 31615495Reddy RS, Tedla JS, Dixit S, Abohashrh M. Cervical proprioception and its relationship with neck pain intensity in subjects with cervical spondylosis. BMC Musculoskelet Disord. 2019 Oct 15;20(1):447. doi: 10.1186/s12891-019-2846-z.
- Background: PubMed 17702636Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control. Man Ther. 2008 Feb;13(1):2-11. doi: 10.1016/j.math.2007.06.003. Epub 2007 Aug 16.
- Background: PubMed 18180194Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control--Part 2: case studies. Man Ther. 2008 Jun;13(3):266-75. doi: 10.1016/j.math.2007.11.002. Epub 2008 Jan 3.
- Background: PubMed 33464539Peng B, Yang L, Li Y, Liu T, Liu Y. Cervical Proprioception Impairment in Neck Pain-Pathophysiology, Clinical Evaluation, and Management: A Narrative Review. Pain Ther. 2021 Jun;10(1):143-164. doi: 10.1007/s40122-020-00230-z. Epub 2021 Jan 12.
- BackgroundJeannerod, M. 1994. "The representing brain: Neural correlates of motor intention and imagery", Cambridge University Press, 187-202.
- Background: PubMed 23583615Hetu S, Gregoire M, Saimpont A, Coll MP, Eugene F, Michon PE, Jackson PL. The neural network of motor imagery: an ALE meta-analysis. Neurosci Biobehav Rev. 2013 Jun;37(5):930-49. doi: 10.1016/j.neubiorev.2013.03.017. Epub 2013 Apr 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özlem Ülger, Prof study director
Hacettepe University
Bahar Güntekin, Prof study director
Medipol University
Ayşenur Zaim, Master (Canditate) principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateralization Imagery Training in people with Chronic Pain and Neck Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Status Assessment (Montreal Cognitive Assessment: MoCA) (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06679335, which also lists 50 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.