- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06679335
Examining the Effect of Lateralization Imagery Training on EEG Brain Oscillations in Individuals With Chronic Neck Pain
Examining the Effect of Lateralization Imagery Training on EEG Brain Oscillations, Pain Intensity, Proprioception, Kinesiophobia and Body Awareness in Individuals With Chronic Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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BESIKTAS
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Istanbul, BESIKTAS, Turkey (Türkiye), 34353
- Bahcesehir Universty
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Inclusion criteria
- 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.
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.
Exclusion criteria
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Neck Pain Patients
|
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. |
|
Active Comparator: Healty Controls
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
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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.
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Baseline, and up to 4 weeks
|
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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.
|
Baseline
|
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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.
|
Baseline, and up to 4 weeks
|
|
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.
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Baseline, and up to 4 weeks
|
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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".
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Baseline, and up to 4 weeks
|
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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.
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Baseline, and up to 4 weeks
|
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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.
|
Baseline, and up to 4 weeks
|
|
EEG power in alpha, theta, beta band
Time Frame: Baseline, and up to 4 weeks
|
Evaluation of brain oscillations with EEG analysis.
|
Baseline, and up to 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ozlem Ulger, Prof, Hacettepe University
- Study Director: Bahar Güntekin, Prof, Medipol University
- Principal Investigator: Ayşenur Zaim, Master (Canditate), Medipol University
- Principal Investigator: Ayşegül Bostan, PhD (Candidate), Hacettepe University
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAU-AYSEGULBOSTAN-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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