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

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05999565
• Other study ID #: Tugbadere
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 4, 2024
• Est. completion date: September 2, 2024

Study information

• Verified date: December 2023
• Source: Hacettepe University
• Contact: Tugba Dere, PT, MsC
• Phone: 05435174957
• Email: dere_tugba[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2, 2024
• Est. primary completion date: July 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disc Herniation
• Hernia
• Image, Body
• Intervertebral Disc Displacement
• Neck Pain

Intervention

Other:
• Motor Imagery Exercises
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.
• Motor Control Exercises
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.

Locations

Country	Name	City	State
Turkey	School of Sarikaya Physical Therapy and Rehabilitation	Yozgat
Turkey	Tugba DERE	Yozgat

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (23)

Abdel-Aziem AA, Mohamed RR, Draz AH, Azab AR, Hegazy FA, Diab RH. The effect of McKenzie protocol vs. deep neck flexor and scapulothoracic exercises in subjects with chronic neck pain - a randomized controlled study. Eur Rev Med Pharmacol Sci. 2022 May;26 — View Citation

Acet N, Güzel N, Günendi Z. Nonspesifik Boyun Agrili Hastalarda Servikal Bölgeye Yapilan Mobilizasyonun Boyun MobilitesiI, Agri, Basinç Agri Esigi ve Dizabilite Üzerine Etkisi. Gazi Saglik Bilimleri Dergisi. 2020;5(2).

Alghadir AH, Iqbal ZA. Effect of Deep Cervical Flexor Muscle Training Using Pressure Biofeedback on Pain and Forward Head Posture in School Teachers with Neck Pain: An Observational Study. Biomed Res Int. 2021 May 22;2021:5588580. doi: 10.1155/2021/558858 — View Citation

Aslan E, Karaduman A, Yakut Y, Aras B, Simsek IE, Yagly N. The cultural adaptation, reliability and validity of neck disability index in patients with neck pain: a Turkish version study. Spine (Phila Pa 1976). 2008 May 15;33(11):E362-5. doi: 10.1097/BRS.0 — View Citation

Aytar A, Yuruk ZO, Tuzun EH, Baltaci G, Karatas M, Eker L. The Upper Extremity Functional Index (UEFI): cross-cultural adaptation, reliability, and validity of the Turkish version. J Back Musculoskelet Rehabil. 2015;28(3):489-95. doi: 10.3233/BMR-140545. — View Citation

Blomgren J, Strandell E, Jull G, Vikman I, Roijezon U. Effects of deep cervical flexor training on impaired physiological functions associated with chronic neck pain: a systematic review. BMC Musculoskelet Disord. 2018 Nov 28;19(1):415. doi: 10.1186/s1289 — View Citation

Bowering KJ, O'Connell NE, Tabor A, Catley MJ, Leake HB, Moseley GL, Stanton TR. The effects of graded motor imagery and its components on chronic pain: a systematic review and meta-analysis. J Pain. 2013 Jan;14(1):3-13. doi: 10.1016/j.jpain.2012.09.007. — View Citation

Chung S, Jeong YG. Effects of the craniocervical flexion and isometric neck exercise compared in patients with chronic neck pain: A randomized controlled trial. Physiother Theory Pract. 2018 Dec;34(12):916-925. doi: 10.1080/09593985.2018.1430876. Epub 201 — View Citation

Cuenca-Martinez F, Suso-Marti L, Sanchez-Martin D, Soria-Soria C, Serrano-Santos J, Paris-Alemany A, La Touche R, Leon-Hernandez JV. Effects of Motor Imagery and Action Observation on Lumbo-pelvic Motor Control, Trunk Muscles Strength and Level of Perceiv — View Citation

Domenech MA, Sizer PS, Dedrick GS, McGalliard MK, Brismee JM. The deep neck flexor endurance test: normative data scores in healthy adults. PM R. 2011 Feb;3(2):105-10. doi: 10.1016/j.pmrj.2010.10.023. — View Citation

Edmondston SJ, Wallumrod ME, Macleid F, Kvamme LS, Joebges S, Brabham GC. Reliability of isometric muscle endurance tests in subjects with postural neck pain. J Manipulative Physiol Ther. 2008 Jun;31(5):348-54. doi: 10.1016/j.jmpt.2008.04.010. — View Citation

Ganu S, Gor U. Effects of Abdominal Control Feedback and Scapular Stabilization Exercise on Chronic Neck Pain. International Journal of Health Sciences and Research. 2021;11:318-25.

Haff GG, Triplett NT. Essentials of strength training and conditioning 4th edition: Human kinetics; 2015.

Kang DY. Deep cervical flexor training with a pressure biofeedback unit is an effective method for maintaining neck mobility and muscular endurance in college students with forward head posture. J Phys Ther Sci. 2015 Oct;27(10):3207-10. doi: 10.1589/jpts. — View Citation

Ma M, Zhang H, Liu R, Liu H, Yang X, Yin X, Chen S, Wu X. Static and Dynamic Changes of Amplitude of Low-Frequency Fluctuations in Cervical Discogenic Pain. Front Neurosci. 2020 Jul 14;14:733. doi: 10.3389/fnins.2020.00733. eCollection 2020. — View Citation

Neblett R, Mayer TG, Hartzell MM, Williams MJ, Gatchel RJ. The Fear-avoidance Components Scale (FACS): Development and Psychometric Evaluation of a New Measure of Pain-related Fear Avoidance. Pain Pract. 2016 Apr;16(4):435-50. doi: 10.1111/papr.12333. Epu — View Citation

Qian M, Zhao D, Qin T, Md ML, Xu H, Xu B. Increased Expression of Inflammatory Cytokines in Diseased Cervical Intervertebral Disc is Associated with Discogenic Neck Pain. 2023.

Schopflocher D, Harstall C. The descriptive epidemiology of chronic pain. Chronic pain: A health policy perspective. 2008:29-40.

Southerst D, Nordin MC, Cote P, Shearer HM, Varatharajan S, Yu H, Wong JJ, Sutton DA, Randhawa KA, van der Velde GM, Mior SA, Carroll LJ, Jacobs CL, Taylor-Vaisey AL. Is exercise effective for the management of neck pain and associated disorders or whipla — View Citation

Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B. — View Citation

Wand BM, Catley MJ, Rabey MI, O'Sullivan PB, O'Connell NE, Smith AJ. Disrupted Self-Perception in People With Chronic Low Back Pain. Further Evaluation of the Fremantle Back Awareness Questionnaire. J Pain. 2016 Sep;17(9):1001-12. doi: 10.1016/j.jpain.201 — View Citation

Williams SE, Cumming J, Ntoumanis N, Nordin-Bates SM, Ramsey R, Hall C. Further validation and development of the movement imagery questionnaire. J Sport Exerc Psychol. 2012 Oct;34(5):621-46. doi: 10.1123/jsep.34.5.621. — View Citation

Wu B, Yang L, Peng B. Ingrowth of Nociceptive Receptors into Diseased Cervical Intervertebral Disc Is Associated with Discogenic Neck Pain. Pain Med. 2019 Jun 1;20(6):1072-1077. doi: 10.1093/pm/pnz013. Erratum In: Pain Med. 2020 Mar 1;21(3):654. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	September 2023-July 2024 (11 months)
Primary	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.	september 2023-july 2024(11 months)
Primary	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	september 2023-july 2024(11 months)
Primary	Assessment of Pain-Related Beliefs	Pain Catastrophizing Scale Fear Avoidance Beliefs Questionnaire Pain Beliefs Questionnaire	september 2023-july 2024(11 months)
Primary	Evaluation of Functional Status 1	Assessment of Neck Disability; The Neck Disability Index	september 2023-july 2024(11 months)
Primary	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	september 2023-july 2024(11 months)
Primary	Evaluation of Functional Status 3	Assessment of Muscle Endurance: Neck Flexor Muscles, Neck Deep Flexor Muscles, Neck Extensor Muscles	september 2023-july 2024(11 months)
Primary	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	september 2023-july 2024(11 months)
Primary	Evaluation of Functional Status 5	Upper Extremity Functional Index-15	september 2023-july 2024(11 months)
Primary	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).	september 2023-july 2024(11 months)
Primary	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.	september 2023-july 2024(11 months)
Primary	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.	september 2023-july 2024(11 months)
Primary	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.	september 2023-july 2024(11 months)
Primary	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.	september 2023-july 2024(11 months)
Primary	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.	september 2023-july 2024(11 months)
Primary	Evaluation of Avoidance Behavior	For evaluating avoidance behavior due to pain, the Fear-Avoidance Component Scale will be used.	september 2023-july 2024(11 months)
Primary	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 Sen 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	september 2023-july 2024(11 months)
Primary	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.	september 2023-july 2024(11 months)