Neck PainNCT05750472
Left/Right Neck Judgment Performance in Individuals With Neck Pain
An observational study of Neck Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with neck pain and healthy controls
Who may be able to join
- 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.
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahcesehir Universty
Istanbul, Besiktas, 34353
About this study
Official title: Neck Awareness, Cognitive Function and Left/Right Judgment Performance in Individuals With Neck Pain: A Cross-sectional Study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Neck Pain
- Keywords
- Proprioception, Cognitive Function, Neck Pain, Body Images, Imagery
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neck Pain Group | group evaluated with scales | |
| Healthy Group | group evaluated with scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: First day
Secondary outcomes (1)
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.
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 May 2023
- Primary completion30 Oct 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegul Bostan, Bahçeşehir University
- Investigators
- Rsch Asst Aysegul Bostan, PhD candid, Principal investigator, Bahçeşehir UniversityPT Bedia Ozdemir, MSc Candid, Principal investigator, Arel UniversityProf. Ozlem Ulger, Professor, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750472
- Sponsor's protocol ID
- BAU-AYSEGULBOSTAN-002
- Status last verified
- Jun 2024
- First submitted
- 30 Jan 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15999284Popescu 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.
PubMed 32035569Stanton 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.
PubMed 26472296Cohen 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.
PubMed 25659245Falla 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.
PubMed 15223935Curtis 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.
PubMed 28013445Malmstrom 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.
PubMed 23812089Alahmari 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.
PubMed 28800305Osuagwu 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.
PubMed 2544696610. Moseley G. L. The Graded Motor Imagery Handbook. Noigroup publications; 2012.
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.
PubMed 30225144Peng 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.
PubMed 33464539Elsig 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.
PubMed 24957711Downie 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.
PubMed 686873Davidson 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.
PubMed 9139169
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neck Awareness, Cognitive Function and Left/Right Judgment Performance in Individuals With Neck Pain: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05750472
- Acronym / sponsor ID
- BAU-AYSEGULBOSTAN-002
- Conditions
- Neck Pain
- Keywords
- Proprioception, Cognitive Function, Neck Pain, Body Images, Imagery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neck Pain Group | – | –group evaluated with scales |
| Healthy Group | – | –group evaluated with scales |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with neck pain and healthy controls
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Left Right Neck Judgment Task
Time frame: First day
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.
Pain Intensity
Time frame: First day
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.
1 secondary outcome
Kinesiophobia
Time frame: First day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 15999284Fejer 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.
- Background: PubMed 32035569Popescu 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.
- Background: PubMed 26472296Stanton 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.
- Background: PubMed 25659245Cohen 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.
- Background: PubMed 15223935Falla 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.
- Background: PubMed 28013445Curtis 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.
- Background: PubMed 23812089Malmstrom 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.
- Background: PubMed 28800305Alahmari 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.
- Background: PubMed 25446966Osuagwu 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.
- Background10. Moseley G. L. The Graded Motor Imagery Handbook. Noigroup publications; 2012.
- Background: PubMed 30225144Pelletier 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.
- Background: PubMed 33464539Peng 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.
- Individual participant dataSharing planned: No
Related trials for Neck Pain
Not yet recruiting
Comparison of the Effectiveness of Motor Imagery Exercises and Suboccipital Myofascial Release Techniques in Nonspecific Chronic Neck Pain
Non-specific Chronic Neck Pain
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Not yet recruiting
Comparative Effects of Dynamic Cupping and Facilitated Positional Release in Cervicogenic Headache
Cervicogenic Headache
Not yet recruiting
Effects of Cervical SNAGs With and Without Thoracic Manipulation on Neck Pain and Disability in Smartphone Users
Non Specific Neck Pain
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rsch Asst Aysegul Bostan, PhD candid principal investigator
Bahçeşehir University
PT Bedia Ozdemir, MSc Candid principal investigator
Arel University
Prof. Ozlem Ulger, Professor study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Left Right Neck Judgment Task (time frame: First day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05750472, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.