Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
Study NCT ID:
NCT06679335
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2024-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Examining the Effect of Lateralization Imagery Training on EEG Brain Oscillations in Individuals With Chronic Neck Pain
Sponsor:
Bahçeşehir University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: