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Investigation of the Effect of Motor Imagery Training in Individuals With Cervical Discogenic Pain

Primary Purpose

Image, Body, Neck Pain, Disc Herniation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Motor Imagery Exercises
Motor Control Exercises
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Image, Body focused on measuring imagery, neck pain, disc herniation, exercise training, awareness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Being between the ages of 18 and 65, Having a diagnosis of cervical disc herniation based on MRI findings, clinical, and physical examination, Experiencing neck pain for 3 months or longer, Having a resting pain intensity rated 3-7 (moderate severity) on the "Visual Analog Scale" for pain assessment (36), Classifying neck pain according to the 'Neck Pain Task Force' clinical classification system as Grade 3 (neck pain with accompanying neurological symptoms) or above, Having a Mini-Mental Test score of 24 or higher for the evaluation of cognitive functions. Exclusion Criteria: Having a history of spinal tumor, spinal deformities, congenital malformation, or head trauma, Undergoing cervical spine surgery in the last 6 months, Having a presence of systemic, cardiorespiratory, central nervous system, or rheumatic diseases, any musculoskeletal or craniocervical disorders, or a history of headache.

Sites / Locations

  • School of Sarıkaya Physical Therapy and Rehabilitation
  • Tugba DERE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Motor Imagery Training

Motor Control Exercise

Arm Description

Motor Imagery Training Motor Imagery Training will be applied only to the 2nd group, under the supervision of a physiotherapist, twice a week for 8 weeks, for 20 minutes each session. The treatment duration for the 2nd group will be planned to be a total of 50 minutes, including both motor imagery and motor control exercises. Motor imagery sessions will take place in a quiet environment, with individuals comfortably seated. Lateralization Training Kinesthetic Imagery Visual Imagery Mirror-Image Active Exercise: Between weeks 6 and 8 of motor imagery training, the active exercises (Stretching Exercises, Active Exercises, and Endurance Exercises) will be actively performed in front of a mirror

Stretching Exercises: Stretching exercises will be applied to the cervical muscles, pectoral muscles, back, and shoulder muscles. Individuals will be asked to perform flexion, extension, lateral flexion, and rotational normal joint movements in the cervical region, and hold the end position for a few seconds. All stretching exercises will be performed for 15 repetitions. Active Exercises: To strengthen the cervical muscle groups, individuals will be taught how to use a mild to moderate resistance theraband for cervical flexion, extension, and lateral flexion, without compromising the chin tuck movement. Each movement will be performed for 10 repetitions, with 5-second rest intervals between exercises. Endurance Exercises: Before starting the endurance exercises, individuals will be taught the contraction of deep cervical flexors to gain automatic postural stabilization, and they will be instructed to maintain this movement in every exercise and activity.

Outcomes

Primary Outcome Measures

Evaluation of Normal Joint Range of Motion
The cervical region and upper extremity normal range of motion of individuals with cervical discogenic pain will be evaluated using a universal goniometer.
Evaluation of Pain
In order to evaluate the pain levels of individuals with cervical disc herniation, the 10 cm Visual Analog Scale (VAS) developed by Price et al. to evaluate the level of pain in individuals with chronic pain will be used. 0; No pain, 10; means the most severe pain and individuals will be asked to indicate their neck pain level on the line.
Evaluation of Pain
Algometer Device (Baseline Push-Pull Force Gauge®, Fabrication Enterprises, Inc) will be used to evaluate the pain threshold in the individuals included in the study
Assessment of Pain-Related Beliefs
Pain Catastrophizing Scale Fear Avoidance Beliefs Questionnaire Pain Beliefs Questionnaire
Evaluation of Functional Status 1
Assessment of Neck Disability; The Neck Disability Index
Evaluation of Functional Status 2
Assessment of Muscle Strength: To evaluate the cervical and upper extremity muscle strength of individuals with cervical discogenic pain, measurements will be taken during maximum voluntary isometric contractions
Evaluation of Functional Status 3
Assessment of Muscle Endurance: Neck Flexor Muscles, Neck Deep Flexor Muscles, Neck Extensor Muscles
Evaluation of Functional Status 4
Assessment of Upper Extremity Functionality: The Nine-Hole Peg Test will be used to evaluate the upper extremity functionality of the individuals
Evaluation of Functional Status 5
Upper Extremity Functional Index-15
Examination of Pathological Changes in the Disc
Examination of Pathological Changes in the Disc In our study, Magnetic Resonance Imaging (MRI) will be used to determine the structure of the disc and the severity of herniation. MRI is a non-invasive assessment method for examining disc herniation and identifying pathological changes in the disc. With MRI, various parameters will be examined, such as bulging, disc protrusion, disc extrusion, disc sequestration, central/paracentral, posterolateral disc herniation, nerve root compression, and disc degeneration. MRI evaluations will be performed using T2 and T1-weighted sagittal sections and T2-weighted axial sections as references. The anterior-posterior (AP) disc height and herniation thickness from the midpoint of the AP length will be evaluated in millimeters (mm).
Motor Imagery Ability Assessment 1
The Motor Imagery Questionnaire-3 (MIQ-3) is used to assess motor imagery ability. It is designed to evaluate individuals' capacity to mentally simulate and visualize movements in their minds. MIQ-3 is commonly used among athletes, dancers, and individuals engaged in various physical activities.
Motor Imagery Ability Assessment 2
Mental Chronometry is a method used to measure the time it takes for individuals to mentally process and execute specific movements or tasks in their minds. It provides insights into the speed and accuracy of mental movement representations.
Motor Imagery Ability Assessment 3
Lateralization Test is employed to determine the degree of lateralization in individuals, specifically assessing their preference for using one side of the body over the other. It helps to understand the dominance of the left or right hemisphere of the brain in controlling motor functions.
Neck Awareness Assessment
The Fremantle Neck Awareness Questionnaire will be used to assess the level of neck awareness in the individuals included in the study. For the assessment of neck proprioception awareness, the cervical range of motion (CROM) device (Performance Attainment Associates, St. Paul, Minnesota, 55117, United States) will be used.
Evaluation of Movement Fear
The movement fears of the included participants will be assessed using the Tampa Scale for Kinesiophobia (TSK), developed by Kori et al.
Evaluation of Avoidance Behavior
For evaluating avoidance behavior due to pain, the Fear-Avoidance Component Scale will be used.
Evaluation of Participant Satisfaction
For assessing the satisfaction rate of individuals with cervical discogenic pain during the treatment period, the Short Form of Patient Satisfaction Assessment will be used. The form was developed by Hawthorne et al. in 2006, and its Turkish validity has been established by Şen et al. The scale consists of the following scoring criteria: for items 1, 2, 4, and 7: 0=Very satisfied, 1=Satisfied, 2=Neither satisfied nor dissatisfied, 3=Dissatisfied, 4=Very dissatisfied; for items 3 and 6: 0=Strongly agree, 1=Agree, 2=Undecided, 3=Disagree, 4=Strongly disagree, and item 5 is scored as 0=Always, 1=Most of the time, 2=Half of the time, 3=Sometimes, 4=Never. For scoring item 6, it needs to be reversed. The total score obtained from the scale is interpreted as follows: 0-10 points indicate very satisfied, 11-18 points indicate satisfied, 19-26 points indicate dissatisfied, and 27-28 points indicate very dissatisfied. An increase in scores signifies an increase in dissatisfaction level
Evaluation of Participants' Views on the Treatment
The views of individuals with cervical discogenic pain regarding the treatment will be assessed through a specially prepared form for this study. The form includes a total of 5 open-ended questions, addressing the participants' opinions on the treatment they received. Participants will be asked to verbally respond to questions about the changes they observed after the treatment, the contributions of the treatment, the easiest or most challenging aspects of the treatment, and whether they would like to continue with this treatment. The responses of participants to the open-ended questions will be recorded using an audio recording system, and later, the evaluator will listen to the recording and transcribe all the answers in written form.

Secondary Outcome Measures

Full Information

First Posted
July 22, 2023
Last Updated
August 13, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05999565
Brief Title
Investigation of the Effect of Motor Imagery Training in Individuals With Cervical Discogenic Pain
Official Title
Investigation of the Effect of Motor Imagery Training on Pain, Pain Beliefs, Functional Status and Neck Awareness in Individuals With Cervical Discogenic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 4, 2023 (Anticipated)
Primary Completion Date
July 4, 2024 (Anticipated)
Study Completion Date
September 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, motor control exercises including cervical region, upper extremity and scapular region muscles will be applied routinely in individuals with chronic neck pain. The application will been investigating, called motor imagery training, will been carried out together with motor control exercises.
Detailed Description
This training is a mental exercise method based on imagining exercises that are performed actively without any interventional application inside or outside the body, in a comfortable environment and without fatigue. It is thought that motor imagery training applied together with motor control exercises will contribute to the management of chronic neck pain due to cervical disc herniation and symptoms related to pain. All individuals with cervical discogenic pain who met the inclusion criteria were assigned to '1. Group' and '2. It will be divided into two groups. It is planned to include approximately 20 individuals with cervical discogenic pain in each group. The sample size of the study will be determined by the power analysis to be made as a result of the pilot study to be carried out on 10 patients with the support of Biostatistics USA. Group 1: (estimated) 20 Individuals with Cervical Discogenic Pain Group 2: (estimated) 20 Individuals with Cervical Discogenic Pain

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Image, Body, Neck Pain, Disc Herniation
Keywords
imagery, neck pain, disc herniation, exercise training, awareness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motor Imagery Training
Arm Type
Experimental
Arm Description
Motor Imagery Training Motor Imagery Training will be applied only to the 2nd group, under the supervision of a physiotherapist, twice a week for 8 weeks, for 20 minutes each session. The treatment duration for the 2nd group will be planned to be a total of 50 minutes, including both motor imagery and motor control exercises. Motor imagery sessions will take place in a quiet environment, with individuals comfortably seated. Lateralization Training Kinesthetic Imagery Visual Imagery Mirror-Image Active Exercise: Between weeks 6 and 8 of motor imagery training, the active exercises (Stretching Exercises, Active Exercises, and Endurance Exercises) will be actively performed in front of a mirror
Arm Title
Motor Control Exercise
Arm Type
Experimental
Arm Description
Stretching Exercises: Stretching exercises will be applied to the cervical muscles, pectoral muscles, back, and shoulder muscles. Individuals will be asked to perform flexion, extension, lateral flexion, and rotational normal joint movements in the cervical region, and hold the end position for a few seconds. All stretching exercises will be performed for 15 repetitions. Active Exercises: To strengthen the cervical muscle groups, individuals will be taught how to use a mild to moderate resistance theraband for cervical flexion, extension, and lateral flexion, without compromising the chin tuck movement. Each movement will be performed for 10 repetitions, with 5-second rest intervals between exercises. Endurance Exercises: Before starting the endurance exercises, individuals will be taught the contraction of deep cervical flexors to gain automatic postural stabilization, and they will be instructed to maintain this movement in every exercise and activity.
Intervention Type
Other
Intervention Name(s)
Motor Imagery Exercises
Intervention Description
Lateralization Training: Individuals with cervical discogenic pain will receive lateralization training using a mobile application called "Recognize Neck" from the Neuro Orthopaedic Institute in Adelaide, Australia. Kinesthetic Imagery: During this training, individuals will be asked to actively perform exercises and feel the movements. In a quiet environment, a therapist will verbally describe the exercises, and individuals will be asked to imagine the positions of their bodies, the surface they are on, and the desired postures. Visual Imagery: Individuals will be asked to actively perform exercises and visualize the movements. In a quiet environment, a therapist will verbally describe the exercises, and individuals will be asked to mentally visualize their body positions, the surface they are on, and the exercises. Mirror-Image Active Exercise: Between weeks 6 and 8 of motor imagery training, the active exercises in front of a mirror.
Intervention Type
Other
Intervention Name(s)
Motor Control Exercises
Intervention Description
Stretching Exercises: Stretching exercises will be applied to the cervical muscles, pectoral muscles, back, and shoulder muscles. Individuals will be asked to perform flexion, extension, lateral flexion, and rotational normal joint movements in the cervical region, and hold the end position for a few seconds. All stretching exercises will be performed for 15 repetitions. Active Exercises: To strengthen the cervical muscle groups, individuals will be taught how to use a mild to moderate resistance theraband for cervical flexion, extension, and lateral flexion, without compromising the chin tuck movement. Each movement will be performed for 10 repetitions, with 5-second rest intervals between exercises. Endurance Exercises: Before starting the endurance exercises, individuals will be taught the contraction of deep cervical flexors to gain automatic postural stabilization, and they will be instructed to maintain this movement in every exercise and activity.
Primary Outcome Measure Information:
Title
Evaluation of Normal Joint Range of Motion
Description
The cervical region and upper extremity normal range of motion of individuals with cervical discogenic pain will be evaluated using a universal goniometer.
Time Frame
September 2023-July 2024 (11 months)
Title
Evaluation of Pain
Description
In order to evaluate the pain levels of individuals with cervical disc herniation, the 10 cm Visual Analog Scale (VAS) developed by Price et al. to evaluate the level of pain in individuals with chronic pain will be used. 0; No pain, 10; means the most severe pain and individuals will be asked to indicate their neck pain level on the line.
Time Frame
september 2023-july 2024(11 months)
Title
Evaluation of Pain
Description
Algometer Device (Baseline Push-Pull Force Gauge®, Fabrication Enterprises, Inc) will be used to evaluate the pain threshold in the individuals included in the study
Time Frame
september 2023-july 2024(11 months)
Title
Assessment of Pain-Related Beliefs
Description
Pain Catastrophizing Scale Fear Avoidance Beliefs Questionnaire Pain Beliefs Questionnaire
Time Frame
september 2023-july 2024(11 months)
Title
Evaluation of Functional Status 1
Description
Assessment of Neck Disability; The Neck Disability Index
Time Frame
september 2023-july 2024(11 months)
Title
Evaluation of Functional Status 2
Description
Assessment of Muscle Strength: To evaluate the cervical and upper extremity muscle strength of individuals with cervical discogenic pain, measurements will be taken during maximum voluntary isometric contractions
Time Frame
september 2023-july 2024(11 months)
Title
Evaluation of Functional Status 3
Description
Assessment of Muscle Endurance: Neck Flexor Muscles, Neck Deep Flexor Muscles, Neck Extensor Muscles
Time Frame
september 2023-july 2024(11 months)
Title
Evaluation of Functional Status 4
Description
Assessment of Upper Extremity Functionality: The Nine-Hole Peg Test will be used to evaluate the upper extremity functionality of the individuals
Time Frame
september 2023-july 2024(11 months)
Title
Evaluation of Functional Status 5
Description
Upper Extremity Functional Index-15
Time Frame
september 2023-july 2024(11 months)
Title
Examination of Pathological Changes in the Disc
Description
Examination of Pathological Changes in the Disc In our study, Magnetic Resonance Imaging (MRI) will be used to determine the structure of the disc and the severity of herniation. MRI is a non-invasive assessment method for examining disc herniation and identifying pathological changes in the disc. With MRI, various parameters will be examined, such as bulging, disc protrusion, disc extrusion, disc sequestration, central/paracentral, posterolateral disc herniation, nerve root compression, and disc degeneration. MRI evaluations will be performed using T2 and T1-weighted sagittal sections and T2-weighted axial sections as references. The anterior-posterior (AP) disc height and herniation thickness from the midpoint of the AP length will be evaluated in millimeters (mm).
Time Frame
september 2023-july 2024(11 months)
Title
Motor Imagery Ability Assessment 1
Description
The Motor Imagery Questionnaire-3 (MIQ-3) is used to assess motor imagery ability. It is designed to evaluate individuals' capacity to mentally simulate and visualize movements in their minds. MIQ-3 is commonly used among athletes, dancers, and individuals engaged in various physical activities.
Time Frame
september 2023-july 2024(11 months)
Title
Motor Imagery Ability Assessment 2
Description
Mental Chronometry is a method used to measure the time it takes for individuals to mentally process and execute specific movements or tasks in their minds. It provides insights into the speed and accuracy of mental movement representations.
Time Frame
september 2023-july 2024(11 months)
Title
Motor Imagery Ability Assessment 3
Description
Lateralization Test is employed to determine the degree of lateralization in individuals, specifically assessing their preference for using one side of the body over the other. It helps to understand the dominance of the left or right hemisphere of the brain in controlling motor functions.
Time Frame
september 2023-july 2024(11 months)
Title
Neck Awareness Assessment
Description
The Fremantle Neck Awareness Questionnaire will be used to assess the level of neck awareness in the individuals included in the study. For the assessment of neck proprioception awareness, the cervical range of motion (CROM) device (Performance Attainment Associates, St. Paul, Minnesota, 55117, United States) will be used.
Time Frame
september 2023-july 2024(11 months)
Title
Evaluation of Movement Fear
Description
The movement fears of the included participants will be assessed using the Tampa Scale for Kinesiophobia (TSK), developed by Kori et al.
Time Frame
september 2023-july 2024(11 months)
Title
Evaluation of Avoidance Behavior
Description
For evaluating avoidance behavior due to pain, the Fear-Avoidance Component Scale will be used.
Time Frame
september 2023-july 2024(11 months)
Title
Evaluation of Participant Satisfaction
Description
For assessing the satisfaction rate of individuals with cervical discogenic pain during the treatment period, the Short Form of Patient Satisfaction Assessment will be used. The form was developed by Hawthorne et al. in 2006, and its Turkish validity has been established by Şen et al. The scale consists of the following scoring criteria: for items 1, 2, 4, and 7: 0=Very satisfied, 1=Satisfied, 2=Neither satisfied nor dissatisfied, 3=Dissatisfied, 4=Very dissatisfied; for items 3 and 6: 0=Strongly agree, 1=Agree, 2=Undecided, 3=Disagree, 4=Strongly disagree, and item 5 is scored as 0=Always, 1=Most of the time, 2=Half of the time, 3=Sometimes, 4=Never. For scoring item 6, it needs to be reversed. The total score obtained from the scale is interpreted as follows: 0-10 points indicate very satisfied, 11-18 points indicate satisfied, 19-26 points indicate dissatisfied, and 27-28 points indicate very dissatisfied. An increase in scores signifies an increase in dissatisfaction level
Time Frame
september 2023-july 2024(11 months)
Title
Evaluation of Participants' Views on the Treatment
Description
The views of individuals with cervical discogenic pain regarding the treatment will be assessed through a specially prepared form for this study. The form includes a total of 5 open-ended questions, addressing the participants' opinions on the treatment they received. Participants will be asked to verbally respond to questions about the changes they observed after the treatment, the contributions of the treatment, the easiest or most challenging aspects of the treatment, and whether they would like to continue with this treatment. The responses of participants to the open-ended questions will be recorded using an audio recording system, and later, the evaluator will listen to the recording and transcribe all the answers in written form.
Time Frame
september 2023-july 2024(11 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being between the ages of 18 and 65, Having a diagnosis of cervical disc herniation based on MRI findings, clinical, and physical examination, Experiencing neck pain for 3 months or longer, Having a resting pain intensity rated 3-7 (moderate severity) on the "Visual Analog Scale" for pain assessment (36), Classifying neck pain according to the 'Neck Pain Task Force' clinical classification system as Grade 3 (neck pain with accompanying neurological symptoms) or above, Having a Mini-Mental Test score of 24 or higher for the evaluation of cognitive functions. Exclusion Criteria: Having a history of spinal tumor, spinal deformities, congenital malformation, or head trauma, Undergoing cervical spine surgery in the last 6 months, Having a presence of systemic, cardiorespiratory, central nervous system, or rheumatic diseases, any musculoskeletal or craniocervical disorders, or a history of headache.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tuğba Dere, PT, MsC
Phone
05435174957
Email
dere_tugba@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İpek GÜRBÜZ, PT, Prof
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
School of Sarıkaya Physical Therapy and Rehabilitation
City
Yozgat
Country
Turkey
Facility Name
Tugba DERE
City
Yozgat
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
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Investigation of the Effect of Motor Imagery Training in Individuals With Cervical Discogenic Pain

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