Neck PainNCT06504004
Chronic Neck Pain and Cognitive Function
An observational study of Neck Pain and Cognitive Symptom, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Background: The aim of this study was to investigate the relationship between cognitive function and pain, functional limitations, and cervical muscle endurance in individuals with chronic neck pain (CNP). 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, Cognitive Symptom
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 20 Jun 2024
- 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: It is worth noting that all individuals participating in the study provided written informed consent. The study involved individuals between the ages of 18 and 65 who had been experiencing neck pain at rest with a score of 3 or more on the VAS for at least 3 months.
Who may be able to join
- It is worth noting that all individuals participating in the study provided written informed consent. The study involved individuals between the ages of 18 and 65 who had been experiencing neck pain at rest with a score of 3 or more on the VAS for at least 3 months.
Who cannot join
- It was ensured that these individuals did not have any neurological deficits or pathological findings, such as fracture, dislocation, tumor, or infection, in radiological examinations.
- Neurological or psychiatric diseases, a history of head trauma resulting in loss of consciousness, epilepsy, a history of neurosurgical intervention, intracranial hypertension, cancer, diabetes, dementia, brain dysfunction, psychological problems such as depression and anxiety diagnosed by a specialist physician and receiving treatment for these diseases
- Individuals who were illiterate.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
School of Sarıkaya Physical Therapy and Rehabilitation
Yozgat
About this study
Official title: Chronic Neck Pain: A Comprehensive Study of the Relationship Between Cognitive Function and Functional Status
Background: The aim of this study was to investigate the relationship between cognitive function and pain, functional limitations, and cervical muscle endurance in individuals with chronic neck pain (CNP).
Methods: The study included 29 individuals (28F, 1M) aged between 18 and 65 years, with non-specific neck pain lasting for at least 3 months, non-neurological symptoms, and no history of head, neck or upper extremity surgery in the last 6 months. Cognitive functions were assessed using the Montreal Cognitive Assessment (MOCA) and Trail Making Test (TMT), pain level using the Visual Analog Scale (VAS) and Bournemouth Neck Pain Questionnaire (BNPQ), functional limitations using the The Profile Fitness Mapping neck questionnaire (ProFitMap-neck) and muscle endurance using cervical flexor, extensor, and deep flexor muscle endurance tests.
Read the detailed description
The study was conducted with ethical approval from the ________ University Ethics Committee (Approval number: 111/2023, Approval Date: 09/12/2023) to investigate the relationship between cognitive functions and functional status in individuals with chronic neck pain. The study adhered to the principles of the Declaration of Helsinki. Power analysis was performed using 'Correlation' with an effect size of 0.5 for the sample size. The statistical test employed in this study was the point biserial model, and the analysis type was 'A priori: Compute required sample size' using G*Power 3.1.9.2 version (Heinrich-Heine-Universität in Düsseldorf, Germany). For the post-hoc power analysis test, the r value between functional limitations and TMT-A test scores was used. It was determined that the study had 90% power with 29 participants.
It is worth noting that all individuals participating in the study provided written informed consent. The study involved individuals between the ages of 18 and 65 who had been experiencing neck pain at rest with a score of 3 or more on the VAS for at least 3 months. It was ensured that these individuals did not have any neurological deficits or pathological findings, such as fracture, dislocation, tumor, or infection, in radiological examinations. Exclusion criteria for the study included individuals with neurological or psychiatric diseases, a history of head trauma resulting in loss of consciousness, epilepsy, a history of neurosurgical intervention, intracranial hypertension, cancer, diabetes, dementia, brain dysfunction, psychological problems such as depression and anxiety diagnosed by a specialist physician and receiving treatment for these diseases, as well as individuals who were illiterate.
Assessment of Pain Severity The study evaluated the degree of neck pain experienced by individuals with chronic neck pain using two different methods: the 10 cm Visual Analogue Scale (VAS) developed by Price et al. Price et al. 1983) and the Bournemouth Neck Pain Questionnaire (BNPQ) developed by Bolton et al (Bolton \& Humphreys 2002). Participants were asked to indicate their level of neck pain on a 10 cm horizontal line, where 0 indicates no pain and 10 indicates unbearable pain, during rest, at night, and during activity. BNPQ evaluates individuals with neck pain based on pain intensity, participation in family and social life, depression, anxiety, kinesiophobia, coping skills with pain in the last week, and other relevant factors. The questionnaire consists of 7 questions, and individuals are asked to score each question on a scale of 0 to 10. The total score ranges from 0 to 70, with higher scores indicating more severe neck pain. Telci et al. conducted a study to assess the validity and reliability of the questionnaire in the Turkish population.
Assessment of Cognitive Status The cognitive status of individuals with chronic neck pain was assessed in the study using the Montreal Cognitive Assessment (MoCA) and Trail Making Test (TMT). The MoCA, a tool for detecting mild cognitive impairment, was developed by Nasreddine et al (Nasreddine et al. 2005). Its Turkish validity and reliability were established by Selekler et al. The total score ranges from 0 to 30, with a score of 26 and above indicating normal cognitive status. TMT is a cognitive assessment tool that evaluates various cognitive functions, including visual-motor coordination, conceptual scanning, motor speed, planning, numerical knowledge, abstract thinking, tendency to react based on the physical characteristics of the stimulus, set switching, concentration, and movement. The questionnaire is divided into two parts, Part A and Part B. Part A assesses psychomotor speed and attention, while Part B assesses executive functions such as set switching, visual scanning speed, and visual alertness. Turkish validity and reliability of the questionnaire was performed by Türkeş et al. (Türkeş et al. 2015).
Evaluation of Functional Status The Profit Neck Mapping Questionnaire (ProFitMap-Neck) was implemented to assess the symptoms and functional limitations of individuals with chronic neck pain. The questionnaire consists of 26 items, including pain, tension, sensation, and balance, which are scored for frequency and severity of each symptom, resulting in two separate scores: symptom frequency score and symptom severity score. The functional limitation scale assesses the difficulty of performing activities such as lifting weights and wearing a t-shirt, resulting in a functional limitation score ranging from 0-100. An increase in the score indicates an improvement in functional status (Björklund et al. 2012).
Stabilizer biofeedback was used to evaluate the endurance of the deep cervical flexor muscles. Patients in a supine position had the stabilizer placed on their cervical region and were instructed to slowly nod their head, simulating a 'yes' movement. The test ranged from 20 mmHg to 30 mmHg, with the pressure needing to be sustained for 10 seconds at every 2 mmHg increase without interruption. The activation score and performance index were determined by evaluating the patient's capacity to execute and sustain 10 repetitions over a 10-second interval at a particular pressure level. The activation score had a maximum value of 10 mmHg, whereas the performance index had a maximum value of 100 (Jull, O'Leary \& Falla 2008). To evaluate the endurance of the neck extensor muscles, a 2 kg weight was attached to the participants at the C6 level using a 10 cm band while lying prone. The maximum time they could maintain an upright head position was measured in seconds (Andias, Neto \& Silva 2018) and recorded. Additionally, the endurance of the cervical flexor muscles was assessed using the cervical flexor muscle endurance test. According to this test, the maximum time that an individual could lift and hold their head at a height of approximately 2.5 cm in a supine hooked position with their hands on their abdomen and chin retracted was recorded (Domenech et al. 2011).
Statistical analysis The descriptive statistics of continuous variables were presented as the mean and standard deviation or the median and quartile, in accordance with the normality assumption. For categorical variables, the frequency (%) was given. All reported p-values were two-tailed. The data were analysed using IBM SPSS Statistics for Windows v.23.0. An examination was conducted to ascertain whether the assumption of normal distribution for the data was satisfied. The results supported the use of the Pearson correlation coefficient, with the exception of certain variables, for which the Spearman correlation coefficient was employed. A significance level of p < 0.05 was established (Fitzgerald etal. 2004).
- Conditions
- Neck Pain, Cognitive Symptom
- Keywords
- Neck pain, cognitive function, functional status
- Medical subject headings
- Neck Pain, Neurobehavioral Manifestations
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-Visual Analogue Scale (VAS)
The study evaluated the degree of neck pain experienced by individuals with chronic neck pain using two different methods: the 10 cm Visual Analogue Scale (VAS) developed by Price et al. Price et al. 1983). Participants were asked to indicate their level of neck pain on a 10 cm horizontal line, where 0 indicates no pain and 10 indicates unbearable pain, during rest, at night, and during activity
Measured: Jun 2024
Pain-Bournemouth Neck Pain Questionnaire (BNPQ)
BNPQ evaluates individuals with neck pain based on pain intensity, participation in family and social life, depression, anxiety, kinesiophobia, coping skills with pain in the last week, and other relevant factors. The questionnaire consists of 7 questions, and individuals are asked to score each question on a scale of 0 to 10. The total score ranges from 0 to 70, with higher scores indicating more severe neck pain. Telci et al. conducted a study to assess the validity and reliability of the questionnaire in the Turkish population.
Measured: Jun 2024
Assessment of Cognitive Status-Montreal Cognitive Assessment (MoCA)
The MoCA, a tool for detecting mild cognitive impairment, was developed by Nasreddine et al (Nasreddine et al. 2005). Its Turkish validity and reliability were established by Selekler et al. The total score ranges from 0 to 30, with a score of 26 and above indicating normal cognitive status.
Measured: Jun 2024
Assessment of Cognitive Status-Trail Making Test (TMT)
TMT is a cognitive assessment tool that evaluates various cognitive functions, including visual-motor coordination, conceptual scanning, motor speed, planning, numerical knowledge, abstract thinking, tendency to react based on the physical characteristics of the stimulus, set switching, concentration, and movement. The questionnaire is divided into two parts, Part A and Part B. Part A assesses psychomotor speed and attention, while Part B assesses executive functions such as set switching, visual scanning speed, and visual alertness. Turkish validity and reliability of the questionnaire was performed by Türkeş et al. (Türkeş et al. 2015).
Measured: Jun 2024
Evaluation of Functional Status-Profit Neck Mapping Questionnaire (ProFitMap-Neck)
The Profit Neck Mapping Questionnaire (ProFitMap-Neck) was implemented to assess the symptoms and functional limitations of individuals with chronic neck pain. The questionnaire consists of 26 items, including pain, tension, sensation, and balance, which are scored for frequency and severity of each symptom, resulting in two separate scores: symptom frequency score and symptom severity score. The functional limitation scale assesses the difficulty of performing activities such as lifting weights and wearing a t-shirt, resulting in a functional limitation score ranging from 0-100. An increase in the score indicates an improvement in functional status (Björklund et al. 2012).
Measured: Jun 2024
Evaluation of Functional Status-Stabilizer biofeedback
Stabilizer biofeedback was used to evaluate the endurance of the deep cervical flexor muscles. Patients in a supine position had the stabilizer placed on their cervical region and were instructed to slowly nod their head, simulating a 'yes' movement. The test ranged from 20 mmHg to 30 mmHg, with the pressure needing to be sustained for 10 seconds at every 2 mmHg increase without interruption. The activation score and performance index were determined by evaluating the patient's capacity to execute and sustain 10 repetitions over a 10-second interval at a particular pressure level.
Measured: Jun 2024
Evaluation of Functional Status-Cervical Flexor Endurance Test
the endurance of the cervical flexor muscles was assessed using the cervical flexor muscle endurance test. According to this test, the maximum time that an individual could lift and hold their head at a height of approximately 2.5 cm in a supine hooked position with their hands on their abdomen and chin retracted was recorded (Domenech et al. 2011).
Measured: Jun 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Jan 2024
- Primary completion20 May 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Bozok University
- Responsible party
- Principal investigator, T Dere, Hacettepe University
- Investigators
- Tuğba Dere, MSc, Principal investigator, Yozgat Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504004
- Sponsor's protocol ID
- YBozok
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beltran-Alacreu H, Lopez-de-Uralde-Villanueva I, Calvo-Lobo C, Fernandez-Carnero J, La Touche R. Clinical features of patients with chronic non-specific neck pain per disability level: A novel observational study. Rev Assoc Med Bras (1992). 2018 Aug;64(8):700-709. doi: 10.1590/1806-9282.64.08.700.
PubMed 30673040Bjorklund M, Hamberg J, Heiden M, Barnekow-Bergkvist M. The ProFitMap-neck--reliability and validity of a questionnaire for measuring symptoms and functional limitations in neck pain. Disabil Rehabil. 2012;34(13):1096-107. doi: 10.3109/09638288.2011.635747. Epub 2011 Dec 12.
PubMed 22149067Hyland-Monks R, Cronin L, McNaughton L, Marchant D. The role of executive function in the self-regulation of endurance performance: A critical review. Prog Brain Res. 2018;240:353-370. doi: 10.1016/bs.pbr.2018.09.011. Epub 2018 Oct 17.
PubMed 30390840Zhao H, Alam A, Chen Q, A Eusman M, Pal A, Eguchi S, Wu L, Ma D. The role of microglia in the pathobiology of neuropathic pain development: what do we know? Br J Anaesth. 2017 Apr 1;118(4):504-516. doi: 10.1093/bja/aex006.
PubMed 28403399
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Neck Pain: A Comprehensive Study of the Relationship Between Cognitive Function and Functional Status
- ClinicalTrials.gov ID
- NCT06504004
- Acronym / sponsor ID
- YBozok
- Conditions
- Neck Pain, Cognitive Symptom
- Keywords
- Neck pain, cognitive function, functional status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Bozok University
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 16 Jul 2024 (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.
Background: The aim of this study was to investigate the relationship between cognitive function and pain, functional limitations, and cervical muscle endurance in individuals with chronic neck pain (CNP).
Methods: The study included 29 individuals (28F, 1M) aged between 18 and 65 years, with non-specific neck pain lasting for at least 3 months, non-neurological symptoms, and no history of head, neck or upper extremity surgery in the last 6 months. Cognitive functions were assessed using the Montreal Cognitive Assessment (MOCA) and Trail Making Test (TMT), pain level using the Visual Analog Scale (VAS) and Bournemouth Neck Pain Questionnaire (BNPQ), functional limitations using the The Profile Fitness Mapping neck questionnaire (ProFitMap-neck) and muscle endurance using cervical flexor, extensor, and deep flexor muscle endurance tests.
Detailed description
The study was conducted with ethical approval from the ________ University Ethics Committee (Approval number: 111/2023, Approval Date: 09/12/2023) to investigate the relationship between cognitive functions and functional status in individuals with chronic neck pain. The study adhered to the principles of the Declaration of Helsinki. Power analysis was performed using 'Correlation' with an effect size of 0.5 for the sample size. The statistical test employed in this study was the point biserial model, and the analysis type was 'A priori: Compute required sample size' using G*Power 3.1.9.2 version (Heinrich-Heine-Universität in Düsseldorf, Germany). For the post-hoc power analysis test, the r value between functional limitations and TMT-A test scores was used. It was determined that the study had 90% power with 29 participants.
It is worth noting that all individuals participating in the study provided written informed consent. The study involved individuals between the ages of 18 and 65 who had been experiencing neck pain at rest with a score of 3 or more on the VAS for at least 3 months. It was ensured that these individuals did not have any neurological deficits or pathological findings, such as fracture, dislocation, tumor, or infection, in radiological examinations. Exclusion criteria for the study included individuals with neurological or psychiatric diseases, a history of head trauma resulting in loss of consciousness, epilepsy, a history of neurosurgical intervention, intracranial hypertension, cancer, diabetes, dementia, brain dysfunction, psychological problems such as depression and anxiety diagnosed by a specialist physician and receiving treatment for these diseases, as well as individuals who were illiterate.
Assessment of Pain Severity The study evaluated the degree of neck pain experienced by individuals with chronic neck pain using two different methods: the 10 cm Visual Analogue Scale (VAS) developed by Price et al. Price et al. 1983) and the Bournemouth Neck Pain Questionnaire (BNPQ) developed by Bolton et al (Bolton \& Humphreys 2002). Participants were asked to indicate their level of neck pain on a 10 cm horizontal line, where 0 indicates no pain and 10 indicates unbearable pain, during rest, at night, and during activity. BNPQ evaluates individuals with neck pain based on pain intensity, participation in family and social life, depression, anxiety, kinesiophobia, coping skills with pain in the last week, and other relevant factors. The questionnaire consists of 7 questions, and individuals are asked to score each question on a scale of 0 to 10. The total score ranges from 0 to 70, with higher scores indicating more severe neck pain. Telci et al. conducted a study to assess the validity and reliability of the questionnaire in the Turkish population.
Assessment of Cognitive Status The cognitive status of individuals with chronic neck pain was assessed in the study using the Montreal Cognitive Assessment (MoCA) and Trail Making Test (TMT). The MoCA, a tool for detecting mild cognitive impairment, was developed by Nasreddine et al (Nasreddine et al. 2005). Its Turkish validity and reliability were established by Selekler et al. The total score ranges from 0 to 30, with a score of 26 and above indicating normal cognitive status. TMT is a cognitive assessment tool that evaluates various cognitive functions, including visual-motor coordination, conceptual scanning, motor speed, planning, numerical knowledge, abstract thinking, tendency to react based on the physical characteristics of the stimulus, set switching, concentration, and movement. The questionnaire is divided into two parts, Part A and Part B. Part A assesses psychomotor speed and attention, while Part B assesses executive functions such as set switching, visual scanning speed, and visual alertness. Turkish validity and reliability of the questionnaire was performed by Türkeş et al. (Türkeş et al. 2015).
Evaluation of Functional Status The Profit Neck Mapping Questionnaire (ProFitMap-Neck) was implemented to assess the symptoms and functional limitations of individuals with chronic neck pain. The questionnaire consists of 26 items, including pain, tension, sensation, and balance, which are scored for frequency and severity of each symptom, resulting in two separate scores: symptom frequency score and symptom severity score. The functional limitation scale assesses the difficulty of performing activities such as lifting weights and wearing a t-shirt, resulting in a functional limitation score ranging from 0-100. An increase in the score indicates an improvement in functional status (Björklund et al. 2012).
Stabilizer biofeedback was used to evaluate the endurance of the deep cervical flexor muscles. Patients in a supine position had the stabilizer placed on their cervical region and were instructed to slowly nod their head, simulating a 'yes' movement. The test ranged from 20 mmHg to 30 mmHg, with the pressure needing to be sustained for 10 seconds at every 2 mmHg increase without interruption. The activation score and performance index were determined by evaluating the patient's capacity to execute and sustain 10 repetitions over a 10-second interval at a particular pressure level. The activation score had a maximum value of 10 mmHg, whereas the performance index had a maximum value of 100 (Jull, O'Leary \& Falla 2008). To evaluate the endurance of the neck extensor muscles, a 2 kg weight was attached to the participants at the C6 level using a 10 cm band while lying prone. The maximum time they could maintain an upright head position was measured in seconds (Andias, Neto \& Silva 2018) and recorded. Additionally, the endurance of the cervical flexor muscles was assessed using the cervical flexor muscle endurance test. According to this test, the maximum time that an individual could lift and hold their head at a height of approximately 2.5 cm in a supine hooked position with their hands on their abdomen and chin retracted was recorded (Domenech et al. 2011).
Statistical analysis The descriptive statistics of continuous variables were presented as the mean and standard deviation or the median and quartile, in accordance with the normality assumption. For categorical variables, the frequency (%) was given. All reported p-values were two-tailed. The data were analysed using IBM SPSS Statistics for Windows v.23.0. An examination was conducted to ascertain whether the assumption of normal distribution for the data was satisfied. The results supported the use of the Pearson correlation coefficient, with the exception of certain variables, for which the Spearman correlation coefficient was employed. A significance level of p < 0.05 was established (Fitzgerald etal. 2004).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- It is worth noting that all individuals participating in the study provided written informed consent. The study involved individuals between the ages of 18 and 65 who had been experiencing neck pain at rest with a score of 3 or more on the VAS for at least 3 months.
Key inclusion criteria (1 listed)
- It is worth noting that all individuals participating in the study provided written informed consent. The study involved individuals between the ages of 18 and 65 who had been experiencing neck pain at rest with a score of 3 or more on the VAS for at least 3 months.
Key exclusion criteria (3 listed)
- It was ensured that these individuals did not have any neurological deficits or pathological findings, such as fracture, dislocation, tumor, or infection, in radiological examinations.
- Neurological or psychiatric diseases, a history of head trauma resulting in loss of consciousness, epilepsy, a history of neurosurgical intervention, intracranial hypertension, cancer, diabetes, dementia, brain dysfunction, psychological problems such as depression and anxiety diagnosed by a specialist physician and receiving treatment for these diseases
- Individuals who were illiterate.
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
Pain-Visual Analogue Scale (VAS)
Time frame: Jun 2024
The study evaluated the degree of neck pain experienced by individuals with chronic neck pain using two different methods: the 10 cm Visual Analogue Scale (VAS) developed by Price et al. Price et al. 1983). Participants were asked to indicate their level of neck pain on a 10 cm horizontal line, where 0 indicates no pain and 10 indicates unbearable pain, during rest, at night, and during activity
Pain-Bournemouth Neck Pain Questionnaire (BNPQ)
Time frame: Jun 2024
BNPQ evaluates individuals with neck pain based on pain intensity, participation in family and social life, depression, anxiety, kinesiophobia, coping skills with pain in the last week, and other relevant factors. The questionnaire consists of 7 questions, and individuals are asked to score each question on a scale of 0 to 10. The total score ranges from 0 to 70, with higher scores indicating more severe neck pain. Telci et al. conducted a study to assess the validity and reliability of the questionnaire in the Turkish population.
Assessment of Cognitive Status-Montreal Cognitive Assessment (MoCA)
Time frame: Jun 2024
The MoCA, a tool for detecting mild cognitive impairment, was developed by Nasreddine et al (Nasreddine et al. 2005). Its Turkish validity and reliability were established by Selekler et al. The total score ranges from 0 to 30, with a score of 26 and above indicating normal cognitive status.
Assessment of Cognitive Status-Trail Making Test (TMT)
Time frame: Jun 2024
TMT is a cognitive assessment tool that evaluates various cognitive functions, including visual-motor coordination, conceptual scanning, motor speed, planning, numerical knowledge, abstract thinking, tendency to react based on the physical characteristics of the stimulus, set switching, concentration, and movement. The questionnaire is divided into two parts, Part A and Part B. Part A assesses psychomotor speed and attention, while Part B assesses executive functions such as set switching, visual scanning speed, and visual alertness. Turkish validity and reliability of the questionnaire was performed by Türkeş et al. (Türkeş et al. 2015).
Evaluation of Functional Status-Profit Neck Mapping Questionnaire (ProFitMap-Neck)
Time frame: Jun 2024
The Profit Neck Mapping Questionnaire (ProFitMap-Neck) was implemented to assess the symptoms and functional limitations of individuals with chronic neck pain. The questionnaire consists of 26 items, including pain, tension, sensation, and balance, which are scored for frequency and severity of each symptom, resulting in two separate scores: symptom frequency score and symptom severity score. The functional limitation scale assesses the difficulty of performing activities such as lifting weights and wearing a t-shirt, resulting in a functional limitation score ranging from 0-100. An increase in the score indicates an improvement in functional status (Björklund et al. 2012).
Evaluation of Functional Status-Stabilizer biofeedback
Time frame: Jun 2024
Stabilizer biofeedback was used to evaluate the endurance of the deep cervical flexor muscles. Patients in a supine position had the stabilizer placed on their cervical region and were instructed to slowly nod their head, simulating a 'yes' movement. The test ranged from 20 mmHg to 30 mmHg, with the pressure needing to be sustained for 10 seconds at every 2 mmHg increase without interruption. The activation score and performance index were determined by evaluating the patient's capacity to execute and sustain 10 repetitions over a 10-second interval at a particular pressure level.
Evaluation of Functional Status-Cervical Flexor Endurance Test
Time frame: Jun 2024
the endurance of the cervical flexor muscles was assessed using the cervical flexor muscle endurance test. According to this test, the maximum time that an individual could lift and hold their head at a height of approximately 2.5 cm in a supine hooked position with their hands on their abdomen and chin retracted was recorded (Domenech et al. 2011).
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 16 Jul 2024.
- Background: PubMed 30673040Beltran-Alacreu H, Lopez-de-Uralde-Villanueva I, Calvo-Lobo C, Fernandez-Carnero J, La Touche R. Clinical features of patients with chronic non-specific neck pain per disability level: A novel observational study. Rev Assoc Med Bras (1992). 2018 Aug;64(8):700-709. doi: 10.1590/1806-9282.64.08.700.
- Background: PubMed 22149067Bjorklund M, Hamberg J, Heiden M, Barnekow-Bergkvist M. The ProFitMap-neck--reliability and validity of a questionnaire for measuring symptoms and functional limitations in neck pain. Disabil Rehabil. 2012;34(13):1096-107. doi: 10.3109/09638288.2011.635747. Epub 2011 Dec 12.
- Results publication: PubMed 30390840Hyland-Monks R, Cronin L, McNaughton L, Marchant D. The role of executive function in the self-regulation of endurance performance: A critical review. Prog Brain Res. 2018;240:353-370. doi: 10.1016/bs.pbr.2018.09.011. Epub 2018 Oct 17.
- Results publication: PubMed 28403399Zhao H, Alam A, Chen Q, A Eusman M, Pal A, Eguchi S, Wu L, Ma D. The role of microglia in the pathobiology of neuropathic pain development: what do we know? Br J Anaesth. 2017 Apr 1;118(4):504-516. doi: 10.1093/bja/aex006.
- Individual participant dataSharing planned: Undecided
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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.
Tuğba Dere, MSc principal investigator
Yozgat Bozok 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 and Cognitive Symptom, run by Hacettepe 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 1 inclusion and 3 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 16 Jul 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?
Pain-Visual Analogue Scale (VAS) (time frame: Jun 2024). The study lists 7 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 NCT06504004, which also lists 4 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 16 Jul 2024.