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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05750472
Other study ID # BAU-AYSEGULBOSTAN-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date December 30, 2023

Study information

Verified date June 2024
Source Bahçesehir University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Method: The demographic characteristics of individuals who come to the clinic with a complaint of neck pain and meet the inclusion criteria as directed by the doctor will be recorded. The level of neck involvement will be determined according to the Neck Paint Task Force. Functionality level of all participants will be evaluated by Neck Disability Index, pain intensity by Visual Analog Scale, fear of movement by Tampa Kinesiophobia Scale, body awareness by left/right neck rotation, judgment task performance and neck awareness by Fremantle Neck Awareness Questionnaire. Left/right neck rotation decision task performance With the Recognise™ (http://www.nongroup.com/Recognise) application, the participant will be asked to do it on a single type tablet provided by the physiotherapist. After participants practice on 10 images before proceeding to the main tasks, 40 images will be displayed on the tablet screen in random order at five-second intervals. The participant will decide and answer as soon as possible whether the picture is right or left. The average percentage and reaction time of correctly identified images on both sides will then be calculated.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date December 30, 2023
Est. primary completion date October 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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,

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Bahcesehir Universty Istanbul Besiktas

Sponsors (1)

Lead Sponsor Collaborator
Bahçesehir University

Country where clinical trial is conducted

Turkey, 

References & Publications (22)

10. Moseley G. L. The Graded Motor Imagery Handbook. Noigroup publications; 2012.

20. Yilmaz Ö.T, Yakut Y, Uygur F, Ulug N. Tampa kinezyofobi ölçegi"nin Türkçe versiyonu ve test-tekrar test güvenirligi. Fizyoterapi Rehabilitasyon 2011;22(1):44-49.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Eur J Appl Physiol. 2013 Oct;113(10):2501. Eva-Maj, Malmstrom [corrected to Malmstrom, Eva-Maj]; Hans, Westergren [corrected to Westergren, Hans]; Per-Anders, Fransson [corrected to Fransson, Per-Anders]; Mikael, Karlberg [corrected to Karlberg, Mikael]; Mans, Magnusson [corrected to Magnusson, — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — 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.2016.06.003. Epub 2016 Jun 18. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Evaluation of Neck Disability The effect of chronic neck pain on activities of daily living was evaluated with the Neck Disability Index. The index, which evaluates subjective symptoms and activities of daily living, consists of 10 sections (pain severity, personal care, lifting, reading, headache, concentration, work life, driving, sleep and leisure activities). There are 6 options for each section, ranging from 0 to 5 points. The total score ranges from 0 to 50 (0: no disability; 50: maximum disability), and an increase in the total score indicates an increase in disability. In the evaluation of our study, the percentage of each score was calculated by taking the percentage of each score in order to obtain an equal score distribution in case the patients did not answer some questions. 8 percent and six "no apologies" were accepted. First day
Primary 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
Primary 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 Kinesiophobia Fear of movement will be evaluated with the Tampa kinesiophobia scale. Tampa kinesiophobia scale is a 17-item questionnaire developed by Koretal in 1991 for musculoskeletal pain. This scale includes the parameters of injury/re-injury and fear avoidance in related activities. Each question on this scale was scored as (1 = disagree, 4 = strongly agree). While scoring, items 4, 8, 12 and 16 are reversed and then the total score is obtained. The person gets a total score between 17-68. First day
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