NCT05999565

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

January 4, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2024

Completed
Last Updated

March 7, 2025

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

July 22, 2023

Last Update Submit

March 5, 2025

Conditions

Keywords

imageryneck paindisc herniationexercise trainingawareness

Outcome Measures

Primary Outcomes (18)

  • 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)

  • 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)

  • 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)

  • Assessment of Pain-Related Beliefs

    Pain Catastrophizing Scale Fear Avoidance Beliefs Questionnaire Pain Beliefs Questionnaire

    september 2023-july 2024(11 months)

  • Evaluation of Functional Status 1

    Assessment of Neck Disability; The Neck Disability Index

    september 2023-july 2024(11 months)

  • 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)

  • 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)

  • 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)

  • Evaluation of Functional Status 5

    Upper Extremity Functional Index-15

    september 2023-july 2024(11 months)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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

    september 2023-july 2024(11 months)

  • 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)

Study Arms (2)

Motor Imagery Training

EXPERIMENTAL

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

Other: Motor Imagery ExercisesOther: Motor Control Exercises

Motor Control Exercise

EXPERIMENTAL

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.

Other: Motor Control Exercises

Interventions

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 Imagery Training

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.

Motor Control ExerciseMotor Imagery Training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

School of Sarıkaya Physical Therapy and Rehabilitation

Yozgat, Turkey (Türkiye)

Location

Tugba DERE

Yozgat, Turkey (Türkiye)

Location

Related Publications (24)

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

    BACKGROUND
  • 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.

    PMID: 30848823BACKGROUND
  • 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.

    PMID: 32760245BACKGROUND
  • 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.

    BACKGROUND
  • 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(9):3138-3150. doi: 10.26355/eurrev_202205_28731.

    PMID: 35587064BACKGROUND
  • 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 Perceived Fatigue: A Randomized Controlled Trial. Res Q Exerc Sport. 2020 Mar;91(1):34-46. doi: 10.1080/02701367.2019.1645941. Epub 2019 Oct 18.

    PMID: 31626568BACKGROUND
  • 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 whiplash-associated disorders? A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Spine J. 2016 Dec;16(12):1503-1523. doi: 10.1016/j.spinee.2014.02.014. Epub 2014 Feb 15.

    PMID: 24534390BACKGROUND
  • 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/s12891-018-2324-z.

    PMID: 30486819BACKGROUND
  • 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.27.3207. Epub 2015 Oct 30.

    PMID: 26644676BACKGROUND
  • 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.

    BACKGROUND
  • 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. Epub 2012 Nov 15.

    PMID: 23158879BACKGROUND
  • Haff GG, Triplett NT. Essentials of strength training and conditioning 4th edition: Human kinetics; 2015.

    BACKGROUND
  • 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: 10.1155/2021/5588580. eCollection 2021.

    PMID: 34095302BACKGROUND
  • 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. Epub 2015 Jul 31.

    PMID: 26228238BACKGROUND
  • Acet N, Güzel N, Günendi Z. Nonspesifik Boyun Ağrılı Hastalarda Servikal Bölgeye Yapılan Mobilizasyonun Boyun Mobilitesiİ, Ağrı, Basınç Ağrı Eşiği ve Dizabilite Üzerine Etkisi. Gazi Sağlık Bilimleri Dergisi. 2020;5(2).

    BACKGROUND
  • 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.2016.06.003. Epub 2016 Jun 18.

    PMID: 27327235BACKGROUND
  • 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.

    PMID: 23027231BACKGROUND
  • 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.

    PMID: 25322741BACKGROUND
  • 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.

    PMID: 18558277BACKGROUND
  • 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 2018 Jan 24.

    PMID: 29364754BACKGROUND
  • 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.

    PMID: 21333948BACKGROUND
  • 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.0b013e31817144e1.

    PMID: 18469684BACKGROUND
  • 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.

    PMID: 8455963BACKGROUND
  • Dere T, Yurdakul G, Alemdaroglu-Gurbuz I. Effectiveness of motor imagery training in women with chronic neck pain: a single-blind, randomized controlled trial. Physiother Theory Pract. 2025 Dec 11:1-21. doi: 10.1080/09593985.2025.2599423. Online ahead of print.

MeSH Terms

Conditions

Neck PainIntervertebral Disc Displacement

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, Anatomical

Study Officials

  • İpek GÜRBÜZ, PT, Prof

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yozgat Bozok Unıversity

Study Record Dates

First Submitted

July 22, 2023

First Posted

August 21, 2023

Study Start

January 4, 2024

Primary Completion

July 22, 2024

Study Completion

September 2, 2024

Last Updated

March 7, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations