Neck PainNCT06434688
Body Awareness and Mental Fatigue in Neck Pain
An observational study of Neck Pain and Mental Fatigue, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of the study was to examine the difference between mental fatigue, in-body, out-of-body and mindfulness parameters in people with chronic neck pain compared to a healthy control group, and to analyze the relationships between mental fatigue and neck disability level and awareness levels, and between… 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, Mental Fatigue, Mindfulness
- What is being tested?
- Mental Fatigue:, Body Awareness: and Neck Disability Level
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 May 2024to 30 Sep 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: individuals with neck pain and healthy individuals without neck pain
Study Group Inclusion Criteria:
- Having chronic neck pain for at least 3 months.
- Being between 18 and 65 years of age.
- Scoring 5 and above on the Neck Disability Questionnaire.
- Scoring 24 and above on the Mini Mental State Examination.
- To be able to read and write.
- Being volunteer to participate in the study.
Study Group Exclusion Criteria:
- Participation in any physical therapy program in the last 3 months.
- Having the following problems:
- Radiculopathy, myleopathy (motor and sensory loss) and other neurological diseases.
- Inflammatory diseases (rheumatoid arthritis, etc.).
- History of malignancy.
- Congenital spinal cord anomaly and congenital spinal deformities.
- Spinal pathologies, traumatic medulla spinalis injury and other medulla spinalis pathologies.
- Vestibular disorders.
- Diagnosed psychiatric illnesses such as bipolar disorder, psychotic illnesses and panic attacks.
- Vision problems that do not fully recover despite vision aids (glasses, etc.).
- Pregnancy status
Control Group Inclusion Criteria:
- Age between 18 and 65 years.
- Scoring 24 and above on the Mini Mental State Examination.
- To be able to read and write.
- Volunteering to participate in the study.
Control Group Exclusion Criteria:
- Having chronic pain in the spine, especially in the neck.
- Exclusion criteria for the study group
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, Sıhhiye, 06100
Selenay Aydoğdu, 1, 5312723599 ext. +90, selenay.aydgd@gmail.com
Nezire Köse, 2, 3052525 ext. 0312, nkose@hacettepe.edu.tr
About this study
Official title: Examining Mental Fatigue, Body Awareness, and Mindfulness in People With Chronic Neck Pain
The primary aim of the study was to examine the difference between mental fatigue, in-body, out-of-body and mindfulness parameters in people with chronic neck pain compared to a healthy control group, and to analyze the relationships between mental fatigue and neck disability level and awareness levels, and between awareness levels and neck disability level and quality of life.
The secondary aim was to examine the relationships between pain intensity, frequency, duration, pain self-efficacy, physical condition, anxiety and depression, mental fatigue and awareness levels in people with chronic neck pain.
Read the detailed description
Neck pain is a prevalent musculoskeletal issue that can cause significant disability. Individuals with neck pain may experience changes in muscle structure and behavior, as well as sensory-perceptual-motor issues such as decreased proprioception and related neuromuscular changes. Additionally, neck pain can lead to psychological problems such as anxiety and depression.Although some awareness parameters have been evaluated in studies on neck pain in the literature and it has been shown that chronic pain is associated with impaired body awareness and that this impairment contributes to and/or maintains chronic pain, no study has been found to examine all awareness parameters in detail. Another cause that compromises the accuracy of information contributing to body awareness is mental fatigue. Mental fatigue can negatively affect a person's level of perception. In one study, it was stated that mental fatigue was a determinant of neck disability, but studies on this subject were found to be very insufficient. Therefore, the aim of this study was to examine the sub-parameters of awareness and mental fatigue in people with chronic neck pain, to compare them with healthy people and to examine the relationship between the parameters evaluated.
- Conditions
- Neck Pain, Mental Fatigue, Mindfulness, Awareness
- Being tested
- Mental Fatigue:, Body Awareness:, Neck Disability Level, Quality Of Life, Pain Assessment:
- Keywords
- mental fatigue, Mindfulness, Interoception, Proprioception
- Medical subject headings
- Neck Pain, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Fatigue:Other
The Mental Fatigue Scale (MFS) will be used to assess mental fatigue.
Body Awareness:Other
Individuals' general body awareness will be assessed with the Body Awareness Questionnaire (BAQ).
Neck awareness of individuals will be assessed with the Fremantle Neck Awareness Questionnaire (FreBFA).
Short Form of the Five Facet Mindfulness Questionnaire (FFMQ - Short Form) will be used to assess people's mindfulness.
- In-body awareness:
For the sense of interoception, the Multidimensional Assessment of Interoceptive Awareness Scale, which assesses interoceptive body awareness, will be used.
To evaluate proprioception, a Cervical Range of Motion (CROM) device is used.
The bucket test will be used to assess subjective visual verticality, which is one of the sub-dimensions of verticality perception.
Two scales will be used to assess people's awareness of weight transfer symmetry.
- Out of Body Awareness:
"Right-Left Confusion Hand Test" will be used to evaluate the mental rotation skill within the scope of the sense of extroception.
Neck Disability LevelOther
Neck disability index will be used to assess this parameter.
Quality Of LifeOther
SF-12 will be used to assess quality of life.
Pain Assessment:Other
Pain intensity will be assessed by Visual Analog Scale (VAS). In addition, pain duration and pain frequency will be questioned. The Pain Self-Efficacy Questionnaire will be used to assess the confidence of people with chronic pain to perform certain tasks and behaviors despite their pain.
Physical Condition:Other
Normal range of motion of the cervical region will be evaluated with the "Cervical Range of Motion" device.
New York Posture Rating Scale will be used to evaluate posture.
Symmetry of weight transfer to both lower extremities of the individuals in standing upright position will be evaluated.
Anxiety and Depression:Other
Beck Depression and Beck Anxiety scales will be used to assess depression and anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Individuals experiencing neck pain | Study Group Inclusion Criteria:
* Having chronic neck pain for at least 3 months.
* Being between 18 and 65 years of age.
* Scoring 5 and above on the Neck Disability Questionnaire.
* Scoring 24 and above on the Mini Mental Status Examination.
* Being able to read and write.
* Being willing to participate in the study.
Study Group Exclusion Criteria:
* Participation in any physical therapy program in the last 3 months.
* Having the following problems:
* Radiculopathy, myleopathy (motor and sensory loss) and other neurologic diseases.
* Inflammatory diseases
* History of malignancy.
* Congenital spinal cord anomaly and congenital spinal deformities
* Spinal pathologies, traumatic medulla spinalis injury and other medulla spinalis pathologies.
* Vestibular disorders.
* Diagnosed psychiatric disorders such as bipolar disorder and panic attacks.
* Vision problems that do not improve despite vision aids.
* Pregnancy Receives: Other: Mental Fatigue:; Other: Body Awareness:; Other: Neck Disability Level; Other: Quality Of Life; Other: Pain Assessment:; Other: Physical Condition:; Other: Anxiety and Depression: | |
| Healthy individuals without neck pain | Control Group Inclusion Criteria:
* Age between 18 and 65 years.
* Scoring 24 and above on the Mini Mental State Examination.
* To be able to read and write.
* Volunteering to participate in the study.
Control Group Exclusion Criteria:
* Having chronic pain in the spine, especially in the neck.
* Exclusion criteria for the study group Receives: Other: Mental Fatigue:; Other: Body Awareness:; Other: Quality Of Life; Other: Physical Condition:; Other: Anxiety and Depression: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Fatigue
The Mental Fatigue Scale (MFS) will be used to assess mental fatigue. It includes questions about general fatigue, lack of initiative, mental fatigue, concentration difficulties, memory problems, slowness of thinking, sensitivity to stress, increased tendency to be emotional, irritability, sensitivity to light and noise, decreased or increased sleep. It has a 7-point Likert-type scale and is scored from 0 to 3. A rating of 0 indicates normal functioning, 1 indicates mild problem, 2 indicates significant problem and 3 indicates maximum problem. According to the total score, 0-10= no mental fatigue problem, 10.5-14.5= mild mental fatigue, 15-20= quite serious mental fatigue, ≥ 20.5= serious mental fatigue.
Measured: 2024 may- 2024 July
General Body Awareness
General body awareness of individuals will be assessed with the Body Awareness Questionnaire (BAQ).
Measured: 2024 may- 2024 July
Neck Disability
Neck disability index will be used to assess this parameter. The questionnaire contains 10 questions related to different activities. Each question is scored between 0 and 5. The level of disability is determined according to the total score obtained from the questionnaire. 0-4 = no disability, 5-14 = mild disability, 15-24 = moderate disability, 25- 34 = severe disability, 35 and above = total disability.
Measured: 2024 may- 2024 July
General health questionnaire
The SF-12, which is more practical and shorter than the SF-36 but contains the same sub-dimensions as the SF-36, will be used to assess quality of life. SF-12 consists of 8 sub-dimensions and 12 items including physical functioning (2 items), physical role, body pain, general health, energy, social functioning, emotional role and mental health. The questionnaire scoring is calculated under the headings of physical and mental health, which are the two main components of general health.
Measured: 2024 may - 2024 July
weight transfer awareness
Two scales were used to assess weight transfer awareness. Results will be recorded in kg.
Measured: 2024 may- 2024 July
neck awareness
Individuals' neck awareness will be assessed with the Fremantle Neck Awareness Questionnaire (FreBFA).
Measured: 2024 may- 2024 July
mindfulness
Short Form of the Five Facet Mindfulness Questionnaire (FFMQ - Short Form) will be used to assess people's mindfulness
Measured: 2024 may- 2024 July
interoception
For the sense of interoception, the Multidimensional Assessment of Interoceptive Awareness Scale, which assesses interoceptive body awareness, will be used.
Measured: 2024 may- 2024 July
proprioception
The Cervical Range of Motion (CROM) device is used to assess proprioception. The device assesses proprioception in 6 different directions of the neck.
Measured: 2024 may- 2024 July
verticality
The bucket test will be used to assess subjective visual verticality, which is one of the sub-dimensions of verticality perception.
Measured: 2024 may- 2024 July
extroception
The sense of extroception will be evaluated with the right-left hand confusion test.
Measured: 2024 may- 2024 July
Secondary outcomes (6)
Pain Assessment
Pain intensity will be assessed by Visual Analog Scale (VAS).0: I have no pain 10: I have unbearable pain In addition, pain duration and pain frequency will be questioned.
Measured: 2024 may- 2024 July
Pain self efficacy
The Pain Self-Efficacy Questionnaire will be used to assess the confidence of people with chronic pain to perform certain tasks and behaviors despite their pain. Each item is rated on a 7-point Likert-type scale (0=not at all confident, 6=fully confident). The total score ranges from 0 to 60, with higher scores indicating greater self-efficacy for functioning despite pain.
Measured: 2024 may- 2024 July
Anxiety and Depression
Beck Depression and Beck Anxiety scales will be used to assess depression and anxiety. Both questionnaires have 21 questions and are scored between 0-3. According to the total scores, 0-9 points in the Beck Depression Scale indicates normal level, 10-16 points indicates mild depression, 17-29 points indicates moderate depression and 30-63 points indicates severe depression. On the Beck Anxiety Scale, 0-17 points are classified as low anxiety, 18-24 points as moderate anxiety, and 25 and above points as high anxiety.
Measured: 2024 may- 2024 July
Range of motion
Normal range of motion of the cervical region will be evaluated with the "Cervical Range of Motion" device. Active ranges of motion in flexion-extension, lateral flexion and rotation directions will be recorded with the subjec
Measured: 2024 may- 2024 July
Posture Assesment
New York Posture Rating Scale will be used to evaluate posture. Posture changes that may occur in 13 different parts of the body including head, neck, shoulders, shoulders, back, waist, hip and ankle are observed. According to the results of the observation, five (5) points are given if the person has proper posture, three (3) points if the posture is moderately impaired, and one (1) point if there is a serious impairment. A high score means that the posture is good.
Measured: 2024 may- 2024 July
Weight transfer
Symmetry of weight transfer to both lower extremities of the individuals in a standing upright position will be evaluated. It will be recorded in kg.
Measured: 2024 may- 2024 July
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start27 May 2024 (estimated)
- Primary completion29 Jul 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selenay Aydogdu, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434688
- Sponsor's protocol ID
- 10557444
- Status last verified
- Feb 2024
- First submitted
- 9 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amiri Arimi S, Ghamkhar L, Kahlaee AH. The Relevance of Proprioception to Chronic Neck Pain: A Correlational Analysis of Flexor Muscle Size and Endurance, Clinical Neck Pain Characteristics, and Proprioception. Pain Med. 2018 Oct 1;19(10):2077-2088. doi: 10.1093/pm/pnx331.
PubMed 29304254Dere T, Alemdaroglu-Gurbuz I. Muscular endurance and its association with neck pain, disability, neck awareness, and kinesiophobia in patients with chronic neck pain. Somatosens Mot Res. 2024 Sep;41(3):134-141. doi: 10.1080/08990220.2023.2186390. Epub 2023 Mar 10.
PubMed 36897182
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Mental Fatigue, Body Awareness, and Mindfulness in People With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06434688
- Acronym / sponsor ID
- 10557444
- Conditions
- Neck Pain, Mental Fatigue, Mindfulness, Awareness
- Keywords
- mental fatigue, Mindfulness, Interoception, Proprioception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 27 May 2024 (estimated)
- Primary completion
- 29 Jul 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 30 May 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.
The primary aim of the study was to examine the difference between mental fatigue, in-body, out-of-body and mindfulness parameters in people with chronic neck pain compared to a healthy control group, and to analyze the relationships between mental fatigue and neck disability level and awareness levels, and between awareness levels and neck disability level and quality of life.
The secondary aim was to examine the relationships between pain intensity, frequency, duration, pain self-efficacy, physical condition, anxiety and depression, mental fatigue and awareness levels in people with chronic neck pain.
Detailed description
Neck pain is a prevalent musculoskeletal issue that can cause significant disability. Individuals with neck pain may experience changes in muscle structure and behavior, as well as sensory-perceptual-motor issues such as decreased proprioception and related neuromuscular changes. Additionally, neck pain can lead to psychological problems such as anxiety and depression.Although some awareness parameters have been evaluated in studies on neck pain in the literature and it has been shown that chronic pain is associated with impaired body awareness and that this impairment contributes to and/or maintains chronic pain, no study has been found to examine all awareness parameters in detail. Another cause that compromises the accuracy of information contributing to body awareness is mental fatigue. Mental fatigue can negatively affect a person's level of perception. In one study, it was stated that mental fatigue was a determinant of neck disability, but studies on this subject were found to be very insufficient. Therefore, the aim of this study was to examine the sub-parameters of awareness and mental fatigue in people with chronic neck pain, to compare them with healthy people and to examine the relationship between the parameters evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals experiencing neck pain | – | Other: Mental Fatigue:, Other: Body Awareness:, Other: Neck Disability Level, Other: Quality Of Life, Other: Pain Assessment:, Other: Physical Condition:, Other: Anxiety and Depression:Study Group Inclusion Criteria: * Having chronic neck pain for at least 3 months. * Being between 18 and 65 years of age. * Scoring 5 and above on the Neck Disability Questionnaire. * Scoring 24 and above on the Mini Mental Status Examination. * Being able to read and write. * Being willing to participate in the study. Study Group Exclusion Criteria: * Participation in any physical therapy program in the last 3 months. * Having the following problems: * Radiculopathy, myleopathy (motor and sensory loss) and other neurologic diseases. * Inflammatory diseases * History of malignancy. * Congenital spinal cord anomaly and congenital spinal deformities * Spinal pathologies, traumatic medulla spinalis injury and other medulla spinalis pathologies. * Vestibular disorders. * Diagnosed psychiatric disorders such as bipolar disorder and panic attacks. * Vision problems that do not improve despite vision aids. * Pregnancy |
| Healthy individuals without neck pain | – | Other: Mental Fatigue:, Other: Body Awareness:, Other: Quality Of Life, Other: Physical Condition:, Other: Anxiety and Depression:Control Group Inclusion Criteria: * Age between 18 and 65 years. * Scoring 24 and above on the Mini Mental State Examination. * To be able to read and write. * Volunteering to participate in the study. Control Group Exclusion Criteria: * Having chronic pain in the spine, especially in the neck. * Exclusion criteria for the study group |
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 individuals without neck pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental Fatigue:The Mental Fatigue Scale (MFS) will be used to assess mental fatigue. | Other | Healthy individuals without neck pain, Individuals experiencing neck pain |
| Body Awareness:Individuals' general body awareness will be assessed with the Body Awareness Questionnaire (BAQ). Neck awareness of individuals will be assessed with the Fremantle Neck Awareness Questionnaire (FreBFA). Short Form of the Five Facet Mindfulness Questionnaire (FFMQ - Short Form) will be used to assess people's mindfulness. - In-body awareness: For the sense of interoception, the Multidimensional Assessment of Interoceptive Awareness Scale, which assesses interoceptive body awareness, will be used. To evaluate proprioception, a Cervical Range of Motion (CROM) device is used. The bucket test will be used to assess subjective visual verticality, which is one of the sub-dimensions of verticality perception. Two scales will be used to assess people's awareness of weight transfer symmetry. - Out of Body Awareness: "Right-Left Confusion Hand Test" will be used to evaluate the mental rotation skill within the scope of the sense of extroception. | Other | Healthy individuals without neck pain, Individuals experiencing neck pain |
| Neck Disability LevelNeck disability index will be used to assess this parameter. | Other | Individuals experiencing neck pain |
| Quality Of LifeSF-12 will be used to assess quality of life. | Other | Healthy individuals without neck pain, Individuals experiencing neck pain |
| Pain Assessment:Pain intensity will be assessed by Visual Analog Scale (VAS). In addition, pain duration and pain frequency will be questioned. The Pain Self-Efficacy Questionnaire will be used to assess the confidence of people with chronic pain to perform certain tasks and behaviors despite their pain. | Other | Individuals experiencing neck pain |
| Physical Condition:Normal range of motion of the cervical region will be evaluated with the "Cervical Range of Motion" device. New York Posture Rating Scale will be used to evaluate posture. Symmetry of weight transfer to both lower extremities of the individuals in standing upright position will be evaluated. | Other | Healthy individuals without neck pain, Individuals experiencing neck pain |
| Anxiety and Depression:Beck Depression and Beck Anxiety scales will be used to assess depression and anxiety. | Other | Healthy individuals without neck pain, Individuals experiencing neck pain |
Primary outcome
Mental Fatigue
Time frame: 2024 may- 2024 July
The Mental Fatigue Scale (MFS) will be used to assess mental fatigue. It includes questions about general fatigue, lack of initiative, mental fatigue, concentration difficulties, memory problems, slowness of thinking, sensitivity to stress, increased tendency to be emotional, irritability, sensitivity to light and noise, decreased or increased sleep. It has a 7-point Likert-type scale and is scored from 0 to 3. A rating of 0 indicates normal functioning, 1 indicates mild problem, 2 indicates significant problem and 3 indicates maximum problem. According to the total score, 0-10= no mental fatigue problem, 10.5-14.5= mild mental fatigue, 15-20= quite serious mental fatigue, ≥ 20.5= serious mental fatigue.
General Body Awareness
Time frame: 2024 may- 2024 July
General body awareness of individuals will be assessed with the Body Awareness Questionnaire (BAQ).
Neck Disability
Time frame: 2024 may- 2024 July
Neck disability index will be used to assess this parameter. The questionnaire contains 10 questions related to different activities. Each question is scored between 0 and 5. The level of disability is determined according to the total score obtained from the questionnaire. 0-4 = no disability, 5-14 = mild disability, 15-24 = moderate disability, 25- 34 = severe disability, 35 and above = total disability.
General health questionnaire
Time frame: 2024 may - 2024 July
The SF-12, which is more practical and shorter than the SF-36 but contains the same sub-dimensions as the SF-36, will be used to assess quality of life. SF-12 consists of 8 sub-dimensions and 12 items including physical functioning (2 items), physical role, body pain, general health, energy, social functioning, emotional role and mental health. The questionnaire scoring is calculated under the headings of physical and mental health, which are the two main components of general health.
weight transfer awareness
Time frame: 2024 may- 2024 July
Two scales were used to assess weight transfer awareness. Results will be recorded in kg.
neck awareness
Time frame: 2024 may- 2024 July
Individuals' neck awareness will be assessed with the Fremantle Neck Awareness Questionnaire (FreBFA).
mindfulness
Time frame: 2024 may- 2024 July
Short Form of the Five Facet Mindfulness Questionnaire (FFMQ - Short Form) will be used to assess people's mindfulness
interoception
Time frame: 2024 may- 2024 July
For the sense of interoception, the Multidimensional Assessment of Interoceptive Awareness Scale, which assesses interoceptive body awareness, will be used.
proprioception
Time frame: 2024 may- 2024 July
The Cervical Range of Motion (CROM) device is used to assess proprioception. The device assesses proprioception in 6 different directions of the neck.
verticality
Time frame: 2024 may- 2024 July
The bucket test will be used to assess subjective visual verticality, which is one of the sub-dimensions of verticality perception.
extroception
Time frame: 2024 may- 2024 July
The sense of extroception will be evaluated with the right-left hand confusion test.
6 secondary outcomes
Pain Assessment
Time frame: 2024 may- 2024 July
Pain self efficacy
Time frame: 2024 may- 2024 July
Anxiety and Depression
Time frame: 2024 may- 2024 July
Range of motion
Time frame: 2024 may- 2024 July
Posture Assesment
Time frame: 2024 may- 2024 July
Weight transfer
Time frame: 2024 may- 2024 July
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Background: PubMed 29304254Amiri Arimi S, Ghamkhar L, Kahlaee AH. The Relevance of Proprioception to Chronic Neck Pain: A Correlational Analysis of Flexor Muscle Size and Endurance, Clinical Neck Pain Characteristics, and Proprioception. Pain Med. 2018 Oct 1;19(10):2077-2088. doi: 10.1093/pm/pnx331.
- Background: PubMed 36897182Dere T, Alemdaroglu-Gurbuz I. Muscular endurance and its association with neck pain, disability, neck awareness, and kinesiophobia in patients with chronic neck pain. Somatosens Mot Res. 2024 Sep;41(3):134-141. doi: 10.1080/08990220.2023.2186390. Epub 2023 Mar 10.
- The Relevance of Proprioception to Chronic Neck Pain: A Correlational Analysis of Flexor Muscle Size and Endurance, Clinical Neck Pain Characteristics, and ProprioceptionLink provided by the sponsor.
- Muscular endurance and its association with neck pain, disability, neck awareness, and kinesiophobia in patients with chronic neck painLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
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 Mental Fatigue, 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?
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: status not confirmed, as of the sponsor's last update on 30 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Fatigue (time frame: 2024 may- 2024 July). The study lists 11 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 NCT06434688, which also lists 2 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 30 May 2024.