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临床试验/NCT05999565
NCT05999565已完成不适用

Investigation of the Effect of Motor Imagery Training on Pain, Pain Beliefs, Functional Status and Neck Awareness in Individuals with Cervical Discogenic Pain

Hacettepe University4 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2024年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
4
主要终点
Evaluation of Functional Status 2

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Evaluation of Functional Status 2

时间窗: september 2023-july 2024(11 months)

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

Examination of Pathological Changes in the Disc

时间窗: september 2023-july 2024(11 months)

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 2

时间窗: september 2023-july 2024(11 months)

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.

Evaluation of Functional Status 1

时间窗: september 2023-july 2024(11 months)

Assessment of Neck Disability; The Neck Disability Index

Evaluation of Functional Status 4

时间窗: september 2023-july 2024(11 months)

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

时间窗: september 2023-july 2024(11 months)

Upper Extremity Functional Index-15

Motor Imagery Ability Assessment 3

时间窗: september 2023-july 2024(11 months)

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.

Motor Imagery Ability Assessment 1

时间窗: september 2023-july 2024(11 months)

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.

Evaluation of Avoidance Behavior

时间窗: september 2023-july 2024(11 months)

For evaluating avoidance behavior due to pain, the Fear-Avoidance Component Scale will be used.

Evaluation of Participant Satisfaction

时间窗: september 2023-july 2024(11 months)

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

Assessment of Pain-Related Beliefs

时间窗: september 2023-july 2024(11 months)

Pain Catastrophizing Scale Fear Avoidance Beliefs Questionnaire Pain Beliefs Questionnaire

Neck Awareness Assessment

时间窗: september 2023-july 2024(11 months)

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

时间窗: september 2023-july 2024(11 months)

The movement fears of the included participants will be assessed using the Tampa Scale for Kinesiophobia (TSK), developed by Kori et al.

Evaluation of Normal Joint Range of Motion

时间窗: September 2023-July 2024 (11 months)

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 Functional Status 3

时间窗: september 2023-july 2024(11 months)

Assessment of Muscle Endurance: Neck Flexor Muscles, Neck Deep Flexor Muscles, Neck Extensor Muscles

Evaluation of Participants' Views on the Treatment

时间窗: september 2023-july 2024(11 months)

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.

Evaluation of Pain

时间窗: september 2023-july 2024(11 months)

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

T Dere

Yozgat Bozok Unıversity

Hacettepe University

研究点 (4)

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