Neck PainNCT05692206
In Chronic Neck Pain; Kinesiophobia, Neck Awareness Examination of Cognitive and Cognitive Functions at Different Levels of Functionality
An observational study of Neck Pain, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
Chronic neck pain is a common problem in our society. With the Neck Disability Index, we can classify the functional status of individuals with chronic neck pain as "no restriction, mildly limited, moderately limited, severely restricted, completely limited". Read more about this study
- Who is it for?
- Ages 40 to 59 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- evaluation
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Feb 2023to 7 Apr 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 40 to 59 years
- All sexes
- No healthy volunteers
- Adult
Study population: According to the neck disability index, those with mild and moderate severity will be determined as the first group, and those who are severely and severely affected will be determined as the second group.
Who may be able to join
- A score of 24 or higher on the Standardized Minimental Test.
- Having chronic neck pain problem for the last 6 months.
- Being between the ages of 40-59.
- Volunteer to participate in the study.
- To be able to read and write.
Who cannot join
- To have a score of 0-4 from the Neck Disability Questionnaire.
- Having undergone musculoskeletal surgery.
- Having a rheumatic or neurological disease.
- pregnancy status
- Having a congenital musculoskeletal disorder.
- The presence of trauma, infectious pathology or scoliosis affecting the spine.
- Any visual impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic neck pain is a common problem in our society. With the Neck Disability Index, we can classify the functional status of individuals with chronic neck pain as "no restriction, mildly limited, moderately limited, severely restricted, completely limited". In this study, the difference between cognitive functions, kinesiophobia and neck awareness between those who have a functional status according to the Neck Disability Index and those whose functional status is "slightly limited-moderately restricted" and those who are "severely limited-totally limited" will be investigated with questionnaires and evaluations. The study will provide information about whether there is a difference between individuals with chronic neck pain regarding cognitive functions, kinesiophobia and neck awareness according to their functional status. Thus, it will contribute to the literature to provide clinicians with awareness about the functionality levels in chronic neck pain and to consider individuals within this framework.
Read the detailed description
Neck pain is a health problem that individuals experience at least once in their lives and that happens to approximately 43% of individuals. Neck pain is the most common chronic pain after chronic low back pain. Situations such as physical strains during any activity, staying in a static posture for a long time, using an inappropriate bag or carrying a weight that forces the individual can affect the structures such as joints, discs, ligaments, and muscles in the cervical region and cause pain. It should not be forgotten that the symptoms seen in individuals with neck pain can be seen to go away on their own within a few weeks, and up to 30% of them can become chronic. Considering that neck pain can become chronic, it will be understood that the physiological and psychological effects of this chronic neck pain on individuals must be evaluated. For this reason, it would be appropriate to evaluate not only the pain but also the functional status in accordance with the biopsychosocial model with special approaches for individuals suffering from chronic neck pain.
Chronic neck pain negatively affects the daily living activities of individuals and causes disability as well as functional limitations. The fact that deaths from neck pain are very rare in general ensures that the main goal of treatment is to improve functional status. For an appropriate and effective treatment planning for individuals, it is necessary to analyze the current functional status of the individual well and to understand which factors affect their functional status.
Recent studies have shown that pain and disability are directly proportional to the increase in degeneration in individuals with chronic neck pain. It was concluded that this ratio was accompanied by physical activities and general health status.
Long sitting times, working conditions, unconscious use of technology, which we often encounter in our daily lives, cause individuals to be physically inactive and lead a sedentary life. In addition, postural problems, decrease in muscle quantity and strength, obesity, chronic diseases, and diseases such as cancer can negatively affect our health in our future lives. These conditions negatively affect the physical health of the society and may also lead to regression in cognitive functions. Psychological variables were also associated with neck pain from the initial stage of neck pain to its chronic stages. Cognitive factors, depression, anxiety and related emotional states are associated with pain and disability and are determinant risk factors for chronic neck pain and disability. Sebastian et al. emphasize that it is important to evaluate certain cognitive abilities at all ages, not just in childhood or old age, in order to observe changes that occur throughout life.
In a study examining the relationship between pain, quality of life and kinesiophobia in nonspecific chronic neck pain, it was determined that patients with chronic neck pain had kinesiophobia. At the end of a study by Demirbüken et al., it was seen that 80.2% of the individuals participating in the study had a high level of fear of movement.
In a disorder in the neck region, muscle dysfunction occurs as a result of pain, disruption of sensory-motor input, and the transfer of the function of the deep muscles to the superficial muscles. These problems can cause the neck to be perceived as asymmetrical, tense, oversized or small, and its position and movement abnormal. In order to eliminate problems such as pain, tension, asymmetry, and deterioration of position-motion perception, it is important for physiotherapists to evaluate and treat in-body and extra-body awareness, and to raise body awareness to a conscious level.
As a result, the results obtained by examining cognitive functions, kinesiophobia and neck awareness according to the affect status of individuals with chronic neck pain are important for individuals to overcome this process quickly and healthily. This study is interesting with its support for an effective treatment and its contribution to the literature.
The study will be carried out with individuals who apply to Malatya Kanalboyu Physical Therapy and Rehabilitation Center with the complaint of chronic neck pain, who meet the inclusion criteria. By examining previous studies, this study was planned to be carried out on 100 people. Demographic information (name, surname, age, gender, telephone) of the individuals participating in the study will be taken.
Neck Disability Index questionnaire will be applied to determine the functionality levels of individuals. The Neck Disability Questionnaire consists of 10 questions related to pain intensity, personal care, lifting, reading, concentration, headache, working, driving, sleeping and recreational activities. There are 6 options for each question, ranging from 0 to 5 points. 0 points means no restrictions, 50 points means full apology. A score of 0-4 means no restriction, a score of 5-14 means mildly restricted, a score of 15-24 moderately restricted, 25-34 severely restricted, and 35 and above means completely restricted. In our study, those with mild and moderate restraints will form the 1st group, and those with severe and complete restraint will form the 2nd group.
Stroop TBAG test will be applied to evaluate cognitive functions. Stroop TBAG Test; It is designed to measure the perceptual setup, the ability to adjust itself to the desired demand under the influence of distraction, the ability to rule out a habitual behavioral movement, and the focusing skills of individuals. The test consists of 5 separate parts in total. From the patient; On the first paper, the words written in black are asked to be read. He is asked to read the words written in color on the second piece of paper. On the third piece of paper, it is asked to say the colors of the circle shapes. On the fourth paper, only the color is asked to be said without reading the unrelated words written in color. On the fifth piece of paper, he is asked to correctly say the color of the words printed in a different color than his own.
Standardized Minimental Test will be applied for cognitive function evaluation. This test consists of five parts: orientation, recording, attention and calculation, recall and language tests. The total score is 30, those who score 24 points or less are at risk for cognitive impairment. A total score of 17 or less is considered severe, a score between 18-23 is considered a moderate disorder, and a score of 24 and above is considered normal.
Tampa Kinesiophobia Scale will be used to measure fear of movement (kinesiophobia). The purpose of developing this scale is to distinguish patients with normal response and high fear of movement. There are 17 questions in the scale and a 4-point Likert scoring is used. After the 4, 8, 12 and 16 items are reversed in the scoring, a total score is calculated and a minimum of 17 and a maximum of 68 points are obtained. The higher the score on the scale, the greater the fear of movement.
The Fremantle Neck Awareness Questionnaire will be used to measure the neck awareness of the individuals participating in the study. The questionnaire asks individuals 9 questions such as how they perceive their neck relative to their body, how they perceive their body position. Likert type assessing individual-specific altered perception (0 = Never/Never feel this way, 1 = I rarely feel this way, 2 = Sometimes, or sometimes I feel this way, 3 = I feel this way often, 4 = I feel this way all or most of the time) It's a simple survey.
- Conditions
- Neck Pain
- Being tested
- evaluation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluationOther
Surveys will be administered to the participants. Participants will be given a stroop TBAG test.
| Study group | Role | What they receive |
|---|---|---|
| according to the neck disability index, mildly and moderately affected | Not described Receives: Other: evaluation | |
| According to the neck disability index, severely affected and very severely affected | Not described Receives: Other: evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive functions
Stroop TBAG test will be applied to evaluate cognitive functions. Stroop TBAG Test; It is designed to measure the perceptual setup, the ability to adjust itself to the desired demand under the influence of distraction, the ability to rule out a habitual behavioral movement, and the focusing skills of individuals. The test consists of 5 separate parts in total. The patient reads the words written in black on the first sheet of paper. The patient reads the words written in color on the second sheet of paper. The patient tells the colors of the circle shapes on the third sheet of paper. The patient simply says the color of the fourth sheet without reading the unrelated words written in color. The patient correctly tells the color of the words printed in a different color from his own color on the fifth paper.
Measured: 8 week
kinesiophobia
Tampa Kinesiophobia Scale will be used to measure fear of movement (kinesiophobia). The purpose of developing this scale is to distinguish patients with normal response and high fear of movement. There are 17 questions in the scale and a 4-point Likert scoring is used. After the 4th, 8th, 12th and 16th items are reversed in scoring, a total score is calculated and a minimum of 17 and a maximum of 68 points are obtained. The higher the score on the scale, the greater the fear of movement.
Measured: 8 week
neck awareness
The Fremantle Neck Awareness Questionnaire will be used to measure the neck awareness of the individuals participating in the study. The questionnaire asks individuals 9 questions such as how they perceive their neck relative to their body, how they perceive their body position. Likert type assessing individual-specific altered perception (0 = Never/Never feel this way, 1 = I rarely feel this way, 2 = Sometimes, or sometimes I feel this way, 3 = I feel this way often, 4 = I feel this way all or most of the time) it is a simple survey.
Measured: 8 week
Neck Disability Index
The Neck Disability Questionnaire consists of 10 questions related to pain intensity, personal care, lifting, reading, concentration, headache, working, driving, sleeping and recreational activities. There are 6 options for each question, ranging from 0 to 5 points. 0 points means no restrictions, 50 points means full apology. A score of 0-4 means no restriction, a score of 5-14 means mildly restricted, a score of 15-24 moderately restricted, 25-34 severely restricted, and 35 and above means completely restricted.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start13 Feb 2023 (estimated)
- Primary completion7 Apr 2023 (estimated)
- Study completion7 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Ozkaya, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692206
- Sponsor's protocol ID
- MustafaKUYO
- Status last verified
- Jan 2023
- First submitted
- 21 Dec 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Chronic Neck Pain; Kinesiophobia, Neck Awareness Examination of Cognitive and Cognitive Functions at Different Levels of Functionality
- ClinicalTrials.gov ID
- NCT05692206
- Acronym / sponsor ID
- MustafaKUYO
- Conditions
- Neck Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 13 Feb 2023 (estimated)
- Primary completion
- 7 Apr 2023 (estimated)
- Study completion
- 7 Apr 2023 (estimated)
- First posted
- 20 Jan 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.
Chronic neck pain is a common problem in our society. With the Neck Disability Index, we can classify the functional status of individuals with chronic neck pain as "no restriction, mildly limited, moderately limited, severely restricted, completely limited". In this study, the difference between cognitive functions, kinesiophobia and neck awareness between those who have a functional status according to the Neck Disability Index and those whose functional status is "slightly limited-moderately restricted" and those who are "severely limited-totally limited" will be investigated with questionnaires and evaluations. The study will provide information about whether there is a difference between individuals with chronic neck pain regarding cognitive functions, kinesiophobia and neck awareness according to their functional status. Thus, it will contribute to the literature to provide clinicians with awareness about the functionality levels in chronic neck pain and to consider individuals within this framework.
Detailed description
Neck pain is a health problem that individuals experience at least once in their lives and that happens to approximately 43% of individuals. Neck pain is the most common chronic pain after chronic low back pain. Situations such as physical strains during any activity, staying in a static posture for a long time, using an inappropriate bag or carrying a weight that forces the individual can affect the structures such as joints, discs, ligaments, and muscles in the cervical region and cause pain. It should not be forgotten that the symptoms seen in individuals with neck pain can be seen to go away on their own within a few weeks, and up to 30% of them can become chronic. Considering that neck pain can become chronic, it will be understood that the physiological and psychological effects of this chronic neck pain on individuals must be evaluated. For this reason, it would be appropriate to evaluate not only the pain but also the functional status in accordance with the biopsychosocial model with special approaches for individuals suffering from chronic neck pain.
Chronic neck pain negatively affects the daily living activities of individuals and causes disability as well as functional limitations. The fact that deaths from neck pain are very rare in general ensures that the main goal of treatment is to improve functional status. For an appropriate and effective treatment planning for individuals, it is necessary to analyze the current functional status of the individual well and to understand which factors affect their functional status.
Recent studies have shown that pain and disability are directly proportional to the increase in degeneration in individuals with chronic neck pain. It was concluded that this ratio was accompanied by physical activities and general health status.
Long sitting times, working conditions, unconscious use of technology, which we often encounter in our daily lives, cause individuals to be physically inactive and lead a sedentary life. In addition, postural problems, decrease in muscle quantity and strength, obesity, chronic diseases, and diseases such as cancer can negatively affect our health in our future lives. These conditions negatively affect the physical health of the society and may also lead to regression in cognitive functions. Psychological variables were also associated with neck pain from the initial stage of neck pain to its chronic stages. Cognitive factors, depression, anxiety and related emotional states are associated with pain and disability and are determinant risk factors for chronic neck pain and disability. Sebastian et al. emphasize that it is important to evaluate certain cognitive abilities at all ages, not just in childhood or old age, in order to observe changes that occur throughout life.
In a study examining the relationship between pain, quality of life and kinesiophobia in nonspecific chronic neck pain, it was determined that patients with chronic neck pain had kinesiophobia. At the end of a study by Demirbüken et al., it was seen that 80.2% of the individuals participating in the study had a high level of fear of movement.
In a disorder in the neck region, muscle dysfunction occurs as a result of pain, disruption of sensory-motor input, and the transfer of the function of the deep muscles to the superficial muscles. These problems can cause the neck to be perceived as asymmetrical, tense, oversized or small, and its position and movement abnormal. In order to eliminate problems such as pain, tension, asymmetry, and deterioration of position-motion perception, it is important for physiotherapists to evaluate and treat in-body and extra-body awareness, and to raise body awareness to a conscious level.
As a result, the results obtained by examining cognitive functions, kinesiophobia and neck awareness according to the affect status of individuals with chronic neck pain are important for individuals to overcome this process quickly and healthily. This study is interesting with its support for an effective treatment and its contribution to the literature.
The study will be carried out with individuals who apply to Malatya Kanalboyu Physical Therapy and Rehabilitation Center with the complaint of chronic neck pain, who meet the inclusion criteria. By examining previous studies, this study was planned to be carried out on 100 people. Demographic information (name, surname, age, gender, telephone) of the individuals participating in the study will be taken.
Neck Disability Index questionnaire will be applied to determine the functionality levels of individuals. The Neck Disability Questionnaire consists of 10 questions related to pain intensity, personal care, lifting, reading, concentration, headache, working, driving, sleeping and recreational activities. There are 6 options for each question, ranging from 0 to 5 points. 0 points means no restrictions, 50 points means full apology. A score of 0-4 means no restriction, a score of 5-14 means mildly restricted, a score of 15-24 moderately restricted, 25-34 severely restricted, and 35 and above means completely restricted. In our study, those with mild and moderate restraints will form the 1st group, and those with severe and complete restraint will form the 2nd group.
Stroop TBAG test will be applied to evaluate cognitive functions. Stroop TBAG Test; It is designed to measure the perceptual setup, the ability to adjust itself to the desired demand under the influence of distraction, the ability to rule out a habitual behavioral movement, and the focusing skills of individuals. The test consists of 5 separate parts in total. From the patient; On the first paper, the words written in black are asked to be read. He is asked to read the words written in color on the second piece of paper. On the third piece of paper, it is asked to say the colors of the circle shapes. On the fourth paper, only the color is asked to be said without reading the unrelated words written in color. On the fifth piece of paper, he is asked to correctly say the color of the words printed in a different color than his own.
Standardized Minimental Test will be applied for cognitive function evaluation. This test consists of five parts: orientation, recording, attention and calculation, recall and language tests. The total score is 30, those who score 24 points or less are at risk for cognitive impairment. A total score of 17 or less is considered severe, a score between 18-23 is considered a moderate disorder, and a score of 24 and above is considered normal.
Tampa Kinesiophobia Scale will be used to measure fear of movement (kinesiophobia). The purpose of developing this scale is to distinguish patients with normal response and high fear of movement. There are 17 questions in the scale and a 4-point Likert scoring is used. After the 4, 8, 12 and 16 items are reversed in the scoring, a total score is calculated and a minimum of 17 and a maximum of 68 points are obtained. The higher the score on the scale, the greater the fear of movement.
The Fremantle Neck Awareness Questionnaire will be used to measure the neck awareness of the individuals participating in the study. The questionnaire asks individuals 9 questions such as how they perceive their neck relative to their body, how they perceive their body position. Likert type assessing individual-specific altered perception (0 = Never/Never feel this way, 1 = I rarely feel this way, 2 = Sometimes, or sometimes I feel this way, 3 = I feel this way often, 4 = I feel this way all or most of the time) It's a simple survey.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| according to the neck disability index, mildly and moderately affected | – | Other: evaluation |
| According to the neck disability index, severely affected and very severely affected | – | Other: evaluation |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- According to the neck disability index, those with mild and moderate severity will be determined as the first group, and those who are severely and severely affected will be determined as the second group.
Key inclusion criteria (5 listed)
- A score of 24 or higher on the Standardized Minimental Test.
- Having chronic neck pain problem for the last 6 months.
- Being between the ages of 40-59.
- Volunteer to participate in the study.
- To be able to read and write.
Key exclusion criteria (7 listed)
- To have a score of 0-4 from the Neck Disability Questionnaire.
- Having undergone musculoskeletal surgery.
- Having a rheumatic or neurological disease.
- pregnancy status
- Having a congenital musculoskeletal disorder.
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 |
|---|---|---|
| evaluationSurveys will be administered to the participants. Participants will be given a stroop TBAG test. | Other | According to the neck disability index, severely affected and very severely affected, according to the neck disability index, mildly and moderately affected |
Primary outcome
cognitive functions
Time frame: 8 week
Stroop TBAG test will be applied to evaluate cognitive functions. Stroop TBAG Test; It is designed to measure the perceptual setup, the ability to adjust itself to the desired demand under the influence of distraction, the ability to rule out a habitual behavioral movement, and the focusing skills of individuals. The test consists of 5 separate parts in total. The patient reads the words written in black on the first sheet of paper. The patient reads the words written in color on the second sheet of paper. The patient tells the colors of the circle shapes on the third sheet of paper. The patient simply says the color of the fourth sheet without reading the unrelated words written in color. The patient correctly tells the color of the words printed in a different color from his own color on the fifth paper.
kinesiophobia
Time frame: 8 week
Tampa Kinesiophobia Scale will be used to measure fear of movement (kinesiophobia). The purpose of developing this scale is to distinguish patients with normal response and high fear of movement. There are 17 questions in the scale and a 4-point Likert scoring is used. After the 4th, 8th, 12th and 16th items are reversed in scoring, a total score is calculated and a minimum of 17 and a maximum of 68 points are obtained. The higher the score on the scale, the greater the fear of movement.
neck awareness
Time frame: 8 week
The Fremantle Neck Awareness Questionnaire will be used to measure the neck awareness of the individuals participating in the study. The questionnaire asks individuals 9 questions such as how they perceive their neck relative to their body, how they perceive their body position. Likert type assessing individual-specific altered perception (0 = Never/Never feel this way, 1 = I rarely feel this way, 2 = Sometimes, or sometimes I feel this way, 3 = I feel this way often, 4 = I feel this way all or most of the time) it is a simple survey.
Neck Disability Index
Time frame: 8 week
The Neck Disability Questionnaire consists of 10 questions related to pain intensity, personal care, lifting, reading, concentration, headache, working, driving, sleeping and recreational activities. There are 6 options for each question, ranging from 0 to 5 points. 0 points means no restrictions, 50 points means full apology. A score of 0-4 means no restriction, a score of 5-14 means mildly restricted, a score of 15-24 moderately restricted, 25-34 severely restricted, and 35 and above means completely restricted.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mustafa Kemal 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Jan 2023. 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?
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?
cognitive functions (time frame: 8 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2023.