NCT05750472

Brief Summary

Neck pain is one of the leading causes of disability worldwide and ranks fourth among the pathologies that result in disability. Although neck pain can be attributed to traumatic or inflammatory disorders, the majority of neck pain has no discernible cause and is considered idiopathic. Neck pain that lasts longer than 3 months takes the form of chronic neck pain. Some problems such as changes in muscle behavior and decrease in proprioceptive sensory input are observed in individuals with chronic neck pain. The presence of such problems, especially the dysfunction of the deep cervical muscles and the inability of the proprioceptors to provide motor control, cause the position sense to be impaired in these individuals and the awareness of the neck of the individuals decreases. The Left Right Judgment Task (LRJT) 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. LRJT performance differences have been hypothesized to reflect changes in central nervous system functioning, errors in judgment, and changes in bodily representations. It has been shown that LRJT is a complex mental task that includes cognitive, sensory, motor and behavioral processes and can be associated with them. Recent studies have revealed that neck pain causes proprioceptive disorder and that proprioceptive training should be done in these individuals. A study showed that there is a strong correlation between biasedness judgment accuracy and proprioception. In this context, the investigators aimed to investigate the knowledge about the effect of individuals with neck pain on proprioception, cortical body diagram and pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

January 30, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

January 30, 2023

Last Update Submit

June 12, 2024

Conditions

Keywords

ProprioceptionCognitive FunctionNeck PainBody ImagesImagery

Outcome Measures

Primary Outcomes (2)

  • The Left Right Neck Judgment Task

    RecogniseTM Hands is an app designed for both iPhone and iPad. As part of a graded motor imagery rehabilitation program, left/right hand discrimination measures decision-making accuracy. The Recognise™ (NOI, Adelaide, Australia) application used in individuals with neck pain to examine the applicability of left /right neck discrimination decision making in neck patients, and it was found to be appropriate. In this context, data will be collected through the Recognise™ (NOI, Adelaide, Australia) application in this study. Individuals will look at the pictures displayed on the online computer and respond to each picture by stating whether the head of the model in the picture is facing left or right relative to their shoulders. Participants are asked to respond as quickly as possible without guessing.

    First day

  • Pain Intensity

    Pain intensity of individuals will be evaluated subjectively with Visual Analog Scale. This scale consists of a 10 cm linear line. The starting point of the line is 0, no pain; endpoint of 10, the most severe pain encountered in life; 5 indicates moderate pain. Individuals will be asked to rate the severity of their pain numerically on the scale.

    First day

Secondary Outcomes (1)

  • Kinesiophobia

    First day

Other Outcomes (1)

  • Evaluation of Neck Disability

    First day

Study Arms (2)

Neck Pain Group

group evaluated with scales

Healthy Group

group evaluated with scales

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals with neck pain and healthy controls

You may qualify if:

  • Individuals who do not experience neck or back pain that interferes with their normal activities, or pain responsible for disability.
  • No previous medical intervention or treatment for a neck problem.

You may not qualify if:

  • To have received treatment in the last 6 months
  • He had neck surgery
  • Suspicion of malignant or systemic disease
  • Neurological disease or injury
  • Vertigo, nausea, visual disturbances,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahcesehir Universty

Istanbul, Besiktas, 34353, Turkey (Türkiye)

Location

Related Publications (22)

  • Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.

    PMID: 15999284BACKGROUND
  • Popescu A, Lee H. Neck Pain and Lower Back Pain. Med Clin North Am. 2020 Mar;104(2):279-292. doi: 10.1016/j.mcna.2019.11.003. Epub 2019 Dec 20.

    PMID: 32035569BACKGROUND
  • Stanton TR, Leake HB, Chalmers KJ, Moseley GL. Evidence of Impaired Proprioception in Chronic, Idiopathic Neck Pain: Systematic Review and Meta-Analysis. Phys Ther. 2016 Jun;96(6):876-87. doi: 10.2522/ptj.20150241. Epub 2015 Oct 15.

    PMID: 26472296BACKGROUND
  • Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.

    PMID: 25659245BACKGROUND
  • Falla D, Bilenkij G, Jull G. Patients with chronic neck pain demonstrate altered patterns of muscle activation during performance of a functional upper limb task. Spine (Phila Pa 1976). 2004 Jul 1;29(13):1436-40. doi: 10.1097/01.brs.0000128759.02487.bf.

    PMID: 15223935BACKGROUND
  • Curtis BR, Fitchett E. A vascular cause of neck pain. Intern Emerg Med. 2017 Sep;12(6):895-897. doi: 10.1007/s11739-016-1592-6. Epub 2016 Dec 24. No abstract available.

    PMID: 28013445BACKGROUND
  • Malmstrom EM, Westergren H, Fransson PA, Karlberg M, Magnusson M. Experimentally induced deep cervical muscle pain distorts head on trunk orientation. Eur J Appl Physiol. 2013 Oct;113(10):2487-99. doi: 10.1007/s00421-013-2683-y. Epub 2013 Jun 29.

    PMID: 23812089BACKGROUND
  • Alahmari KA, Reddy RS, Silvian P, Ahmad I, Nagaraj V, Mahtab M. Influence of chronic neck pain on cervical joint position error (JPE): Comparison between young and elderly subjects. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1265-1271. doi: 10.3233/BMR-169630.

    PMID: 28800305BACKGROUND
  • Osuagwu BA, Vuckovic A. Similarities between explicit and implicit motor imagery in mental rotation of hands: an EEG study. Neuropsychologia. 2014 Dec;65:197-210. doi: 10.1016/j.neuropsychologia.2014.10.029. Epub 2014 Oct 30.

    PMID: 25446966BACKGROUND
  • 10. Moseley G. L. The Graded Motor Imagery Handbook. Noigroup publications; 2012.

    BACKGROUND
  • Pelletier R, Bourbonnais D, Higgins J, Mireault M, Danino MA, Harris PG. Left Right Judgement Task and Sensory, Motor, and Cognitive Assessment in Participants with Wrist/Hand Pain. Rehabil Res Pract. 2018 Aug 26;2018:1530245. doi: 10.1155/2018/1530245. eCollection 2018.

    PMID: 30225144BACKGROUND
  • Peng B, Yang L, Li Y, Liu T, Liu Y. Cervical Proprioception Impairment in Neck Pain-Pathophysiology, Clinical Evaluation, and Management: A Narrative Review. Pain Ther. 2021 Jun;10(1):143-164. doi: 10.1007/s40122-020-00230-z. Epub 2021 Jan 12.

    PMID: 33464539BACKGROUND
  • Elsig S, Luomajoki H, Sattelmayer M, Taeymans J, Tal-Akabi A, Hilfiker R. Sensorimotor tests, such as movement control and laterality judgment accuracy, in persons with recurrent neck pain and controls. A case-control study. Man Ther. 2014 Dec;19(6):555-61. doi: 10.1016/j.math.2014.05.014. Epub 2014 Jun 10.

    PMID: 24957711BACKGROUND
  • Downie WW, Leatham PA, Rhind VM, Wright V, Branco JA, Anderson JA. Studies with pain rating scales. Ann Rheum Dis. 1978 Aug;37(4):378-81. doi: 10.1136/ard.37.4.378.

    PMID: 686873BACKGROUND
  • Davidson CJ, Ganion LR, Gehlsen GM, Verhoestra B, Roepke JE, Sevier TL. Rat tendon morphologic and functional changes resulting from soft tissue mobilization. Med Sci Sports Exerc. 1997 Mar;29(3):313-9. doi: 10.1097/00005768-199703000-00005.

    PMID: 9139169BACKGROUND
  • Telci EA, Karaduman A, Yakut Y, Aras B, Simsek IE, Yagli N. The cultural adaptation, reliability, and validity of neck disability index in patients with neck pain: a Turkish version study. Spine (Phila Pa 1976). 2009 Jul 15;34(16):1732-5. doi: 10.1097/BRS.0b013e3181ac9055.

    PMID: 19770615BACKGROUND
  • 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
  • Onan D, Gokmen D, Ulger O. The Fremantle Neck Awareness Questionnaire in Chronic Neck Pain Patients: Turkish Version, Validity and Reliability Study. Spine (Phila Pa 1976). 2020 Feb 1;45(3):E163-E169. doi: 10.1097/BRS.0000000000003207.

    PMID: 31425430BACKGROUND
  • Haldeman S, Carroll L, Cassidy JD, Schubert J, Nygren A; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. The Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders: executive summary. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S5-7. doi: 10.1097/BRS.0b013e3181643f40. No abstract available.

    PMID: 18204400BACKGROUND
  • 20. Yılmaz Ö.T, Yakut Y, Uygur F, Uluğ N. Tampa kinezyofobi ölçeği"nin Türkçe versiyonu ve test-tekrar test güvenirliği. Fizyoterapi Rehabilitasyon 2011;22(1):44-49.

    BACKGROUND
  • Moseley GL. Why do people with complex regional pain syndrome take longer to recognize their affected hand? Neurology. 2004 Jun 22;62(12):2182-6. doi: 10.1212/01.wnl.0000130156.05828.43.

    PMID: 15210879BACKGROUND
  • Wallwork SB, Butler DS, Fulton I, Stewart H, Darmawan I, Moseley GL. Left/right neck rotation judgments are affected by age, gender, handedness and image rotation. Man Ther. 2013 Jun;18(3):225-30. doi: 10.1016/j.math.2012.10.006. Epub 2013 Jan 26.

    PMID: 23357411BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rsch Asst Aysegul Bostan, PhD candid

    Bahçeşehir University

    PRINCIPAL INVESTIGATOR
  • PT Bedia Ozdemir, MSc Candid

    Arel University

    PRINCIPAL INVESTIGATOR
  • Prof. Ozlem Ulger, Professor

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 30, 2023

First Posted

March 1, 2023

Study Start

May 1, 2023

Primary Completion

October 30, 2023

Study Completion

December 30, 2023

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations