Myofascial Pain Syndrome - NeckNCT07904364
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
An observational study of Myofascial Pain Syndrome - Neck, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate how closely two approaches to assessing pain-related characteristics agree in adults with chronic cervical myofascial pain syndrome (chronic neck pain associated with painful muscle trigger points). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Pain Syndrome - Neck
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2026to 15 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of 150 adults aged 18 years or older diagnosed with chronic cervical myofascial pain syndrome who attend the Physical Medicine and Rehabilitation Outpatient Clinic at Mardin Training and Research Hospital, Türkiye. Eligible participants will have neck pain lasting longer than three months. All participants will undergo a single-visit assessment including IASP clinical nociplastic pain classification, the Central Sensitization Inventory (CSI), the Neck Disability Index (NDI), and the Revised Illness Perception Questionnaire (IPQ-R). Patients will be categorized according to their CSI and IASP classifications. No healthy control group will be included.
Who may be able to join
- Adults aged 18 years or older.
- Neck pain lasting longer than three months.
- Diagnosis of chronic cervical myofascial pain syndrome established by a Physical Medicine and Rehabilitation specialist.
- Willingness to participate and provision of written informed consent.
Who cannot join
- Cervical radiculopathy, myelopathy, or another neurological disorder identified as the primary cause of neck pain.
- Fracture, infection, malignancy, or active inflammatory rheumatic disease explaining the neck pain.
- Diagnosis of fibromyalgia.
- Open wounds, active skin disease, or infection in the examination area that prevents clinical assessment.
- Cognitive impairment or an active severe psychiatric condition that prevents understanding the questions, providing reliable responses, or participating in the clinical examination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Mardin Training and Research Hospital
Mardin, 47100
Taha Y YILDIRIM, M.D., +90 534 220 77 17, tyasinyildirim.ftr@gmail.com
About this study
Official title: Agreement Between Central Sensitization Inventory (CSI) and International Association for the Study of Pain (IASP) Nociplastic Pain Classification and Illness Perception in Chronic Cervical Myofascial Pain Syndrome: A Cross-Sectional Study
This study aims to investigate how closely two approaches to assessing pain-related characteristics agree in adults with chronic cervical myofascial pain syndrome (chronic neck pain associated with painful muscle trigger points).
The Central Sensitization Inventory (CSI) is a questionnaire that assesses symptoms associated with increased pain sensitivity. The International Association for the Study of Pain (IASP) has developed clinical criteria to identify nociplastic pain, a type of pain that cannot be fully explained by tissue damage or nerve injury. These approaches provide different types of information, and it is unclear how often they classify patients with chronic cervical myofascial pain in the same way.
Read more
This observational, cross-sectional study will include 150 adults aged 18 years or older with chronic cervical myofascial pain syndrome.
Participants will undergo a clinical assessment based on the IASP nociplastic pain criteria and complete the CSI, Neck Disability Index (NDI), and Revised Illness Perception Questionnaire (IPQ-R). Pain severity and relevant clinical information will also be recorded.
The main objective is to determine the agreement between CSI classification using a cutoff score of 40 and IASP clinical classification of nociplastic pain.
The study will also examine how often the two approaches produce different classifications and whether patients with matching or differing classifications report different emotional responses to their illness.
All assessments will be completed during a single visit. No experimental treatments or additional invasive procedures will be performed.
Read the detailed description
Chronic cervical myofascial pain syndrome is characterized by persistent neck pain and tenderness associated with active myofascial trigger points. Although myofascial pain is primarily considered nociceptive, some patients may also exhibit nociplastic pain characteristics that are not fully explained by local muscle findings.
The International Association for the Study of Pain (IASP) has proposed clinical criteria for nociplastic pain affecting the musculoskeletal system. These criteria consider pain duration and distribution, whether pain can be fully explained by nociceptive or neuropathic mechanisms, clinically evoked pain hypersensitivity, and associated symptoms.
The Central Sensitization Inventory (CSI) is a patient-reported questionnaire assessing symptoms associated with central sensitivity syndromes. A cutoff score of 40 is commonly used to distinguish patients with higher symptom burden. However, CSI classification does not necessarily correspond to clinical nociplastic pain classification.
The primary objective of this study is to assess the agreement between CSI classification (scores below 40 versus 40 or higher) and IASP clinical classification (not meeting the criteria versus meeting the criteria for at least possible nociplastic pain) in adults with chronic cervical myofascial pain syndrome.
Agreement will be quantified using Cohen's kappa coefficient with a 95% confidence interval. The original IASP categories (not meeting the criteria, possible nociplastic pain, and probable nociplastic pain) will be retained in the study records.
Secondary objectives include determining the overall frequency of disagreement and identifying both directions of discordance: patients with CSI scores of 40 or higher who do not meet IASP criteria, and patients with CSI scores below 40 who meet the criteria for at least possible nociplastic pain.
The study will also investigate whether illness perception differs among the four groups formed by the combination of CSI and IASP classifications. The primary focus of this secondary analysis will be the emotional representations dimension of the Revised Illness Perception Questionnaire (IPQ-R). Differences will be evaluated while accounting for pain severity measured by the Numeric Rating Scale (NRS) and neck-related disability measured by the Neck Disability Index (NDI).
Other IPQ-R dimensions will be examined in exploratory analyses. An additional agreement analysis will be conducted using only the probable nociplastic pain category as the positive IASP classification.
Clinical assessment will be performed before administration of the patient-reported questionnaires. The clinician performing the IASP assessment will not have access to the CSI or IPQ-R results when determining the clinical classification.
The study will be conducted at the Physical Medicine and Rehabilitation Outpatient Clinic of Mardin Training and Research Hospital, Türkiye. All information will be collected during a single assessment visit.
The findings may help clarify how patient-reported symptoms and clinical nociplastic pain criteria relate to one another and whether
- Conditions
- Myofascial Pain Syndrome - Neck
- Keywords
- Myofascial Pain Syndrome, Nociplastic Pain, Central Sensitization Inventory, IASP Nociplastic Pain Criteria, Illness Perception, Revised Illness Perception Questionnaire
- Medical subject headings
- Myofascial Pain Syndromes, Nociplastic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Cervical Myofascial Pain Syndrome Group | Adults aged 18 years or older diagnosed with chronic cervical myofascial pain syndrome and experiencing neck pain for more than three months. Participants will undergo a single-visit clinical assessment based on the International Association for the Study of Pain (IASP) nociplastic pain criteria, followed by the Neck Disability Index (NDI), Central Sensitization Inventory (CSI), and Revised Illness Perception Questionnaire (IPQ-R). Pain severity and demographic and clinical characteristics will also be recorded. CSI and IASP classifications will be compared to assess agreement and disagreement. No experimental treatment or additional invasive procedures will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Between CSI and IASP Nociplastic Pain Classifications
Agreement between the Central Sensitization Inventory (CSI) and the International Association for the Study of Pain (IASP) clinical nociplastic pain classification will be quantified using Cohen's kappa coefficient with a 95% confidence interval. CSI scores will be categorized as below 40 or 40 and above. IASP classifications will be dichotomized as not meeting the criteria or meeting the criteria for at least possible nociplastic pain (possible or probable). Cohen's kappa ranges from -1 to 1, with 1 indicating perfect agreement, 0 indicating agreement expected by chance, and negative values indicating less agreement than expected by chance.
Measured: baseline
Secondary outcomes (5)
Overall Discordance Rate Between CSI and IASP Classifications
The percentage of participants with discordant CSI and IASP classifications will be calculated. Discordance is defined as either a CSI score of 40 or higher without meeting the IASP criteria for nociplastic pain, or a CSI score below 40 while meeting the IASP criteria for at least possible nociplastic pain. The overall discordance rate will be reported as a percentage with a 95% confidence interval calculated using the Wilson method.
Measured: baseline
Discordance Rate for CSI-Positive and IASP-Negative Classification
The percentage of all evaluated participants with a CSI score of 40 or higher who do not meet the IASP clinical criteria for nociplastic pain will be calculated. This represents one direction of disagreement between the two classification approaches. The proportion will be reported with a 95% confidence interval using the Wilson method.
Measured: baseline
Discordance Rate for CSI-Negative and IASP-Positive Classification
The percentage of all evaluated participants with a CSI score below 40 who meet the IASP criteria for at least possible nociplastic pain will be calculated. The IASP-positive category includes possible and probable nociplastic pain. This represents the opposite direction of disagreement between the two classification approaches. The proportion will be reported with a 95% confidence interval using the Wilson method.
Measured: baseline
Differences in IPQ-R Emotional Representations Scores Across CSI-IASP Classification Groups
Emotional responses to illness will be assessed using the Emotional Representations subscale of the Revised Illness Perception Questionnaire (IPQ-R). This subscale consists of 6 items scored from 1 to 5, yielding a total score ranging from 6 to 30. Higher scores indicate stronger negative emotional responses to illness, whereas lower scores indicate fewer negative emotional responses. Scores will be compared across four groups defined by CSI classification (below 40 versus 40 or higher) and IASP classification (not meeting criteria versus at least possible nociplastic pain). Multivariable linear regression will be used to assess group differences after adjustment for pain severity (NRS) and neck-related disability (NDI). Adjusted mean differences and 95% confidence intervals will be reported.
Measured: baseline
Agreement Between CSI Classification and Probable IASP Nociplastic Pain
An additional agreement analysis will be conducted using only the probable nociplastic pain category as the positive IASP classification. Participants not meeting the IASP criteria and those classified as having possible nociplastic pain will form the comparison category. CSI scores will be classified as below 40 or 40 and above. Agreement will be quantified using Cohen's kappa coefficient with a 95% confidence interval.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start10 Dec 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain Syndrome - NeckStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Collaborators
- Mardin Training and Research Hospital
- Responsible party
- Principal investigator, Taha Yasin YILDIRIM, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904364
- Sponsor's protocol ID
- MEAH-PMR-TYY7
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez-de-Las-Penas C, Nijs J, Cagnie B, Gerwin RD, Plaza-Manzano G, Valera-Calero JA, Arendt-Nielsen L. Myofascial Pain Syndrome: A Nociceptive Condition Comorbid with Neuropathic or Nociplastic Pain. Life (Basel). 2023 Mar 3;13(3):694. doi: 10.3390/life13030694.
PubMed 36983849Neblett R, Cohen H, Choi Y, Hartzell MM, Williams M, Mayer TG, Gatchel RJ. The Central Sensitization Inventory (CSI): establishing clinically significant values for identifying central sensitivity syndromes in an outpatient chronic pain sample. J Pain. 2013 May;14(5):438-45. doi: 10.1016/j.jpain.2012.11.012. Epub 2013 Mar 13.
PubMed 23490634Kosek E, Clauw D, Nijs J, Baron R, Gilron I, Harris RE, Mico JA, Rice ASC, Sterling M. Chronic nociplastic pain affecting the musculoskeletal system: clinical criteria and grading system. Pain. 2021 Nov 1;162(11):2629-2634. doi: 10.1097/j.pain.0000000000002324. No abstract available.
PubMed 33974577
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agreement Between Central Sensitization Inventory (CSI) and International Association for the Study of Pain (IASP) Nociplastic Pain Classification and Illness Perception in Chronic Cervical Myofascial Pain Syndrome: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07904364
- Acronym / sponsor ID
- MEAH-PMR-TYY7
- Conditions
- Myofascial Pain Syndrome - Neck
- Keywords
- Myofascial Pain Syndrome, Nociplastic Pain, Central Sensitization Inventory, IASP Nociplastic Pain Criteria, Illness Perception, Revised Illness Perception Questionnaire
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Collaborators
- Mardin Training and Research Hospital
- Study start
- 10 Dec 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 29 Oct 2026 (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.
This study aims to investigate how closely two approaches to assessing pain-related characteristics agree in adults with chronic cervical myofascial pain syndrome (chronic neck pain associated with painful muscle trigger points).
The Central Sensitization Inventory (CSI) is a questionnaire that assesses symptoms associated with increased pain sensitivity. The International Association for the Study of Pain (IASP) has developed clinical criteria to identify nociplastic pain, a type of pain that cannot be fully explained by tissue damage or nerve injury. These approaches provide different types of information, and it is unclear how often they classify patients with chronic cervical myofascial pain in the same way.
This observational, cross-sectional study will include 150 adults aged 18 years or older with chronic cervical myofascial pain syndrome.
Participants will undergo a clinical assessment based on the IASP nociplastic pain criteria and complete the CSI, Neck Disability Index (NDI), and Revised Illness Perception Questionnaire (IPQ-R). Pain severity and relevant clinical information will also be recorded.
The main objective is to determine the agreement between CSI classification using a cutoff score of 40 and IASP clinical classification of nociplastic pain.
The study will also examine how often the two approaches produce different classifications and whether patients with matching or differing classifications report different emotional responses to their illness.
All assessments will be completed during a single visit. No experimental treatments or additional invasive procedures will be performed.
Detailed description
Chronic cervical myofascial pain syndrome is characterized by persistent neck pain and tenderness associated with active myofascial trigger points. Although myofascial pain is primarily considered nociceptive, some patients may also exhibit nociplastic pain characteristics that are not fully explained by local muscle findings.
The International Association for the Study of Pain (IASP) has proposed clinical criteria for nociplastic pain affecting the musculoskeletal system. These criteria consider pain duration and distribution, whether pain can be fully explained by nociceptive or neuropathic mechanisms, clinically evoked pain hypersensitivity, and associated symptoms.
The Central Sensitization Inventory (CSI) is a patient-reported questionnaire assessing symptoms associated with central sensitivity syndromes. A cutoff score of 40 is commonly used to distinguish patients with higher symptom burden. However, CSI classification does not necessarily correspond to clinical nociplastic pain classification.
The primary objective of this study is to assess the agreement between CSI classification (scores below 40 versus 40 or higher) and IASP clinical classification (not meeting the criteria versus meeting the criteria for at least possible nociplastic pain) in adults with chronic cervical myofascial pain syndrome.
Agreement will be quantified using Cohen's kappa coefficient with a 95% confidence interval. The original IASP categories (not meeting the criteria, possible nociplastic pain, and probable nociplastic pain) will be retained in the study records.
Secondary objectives include determining the overall frequency of disagreement and identifying both directions of discordance: patients with CSI scores of 40 or higher who do not meet IASP criteria, and patients with CSI scores below 40 who meet the criteria for at least possible nociplastic pain.
The study will also investigate whether illness perception differs among the four groups formed by the combination of CSI and IASP classifications. The primary focus of this secondary analysis will be the emotional representations dimension of the Revised Illness Perception Questionnaire (IPQ-R). Differences will be evaluated while accounting for pain severity measured by the Numeric Rating Scale (NRS) and neck-related disability measured by the Neck Disability Index (NDI).
Other IPQ-R dimensions will be examined in exploratory analyses. An additional agreement analysis will be conducted using only the probable nociplastic pain category as the positive IASP classification.
Clinical assessment will be performed before administration of the patient-reported questionnaires. The clinician performing the IASP assessment will not have access to the CSI or IPQ-R results when determining the clinical classification.
The study will be conducted at the Physical Medicine and Rehabilitation Outpatient Clinic of Mardin Training and Research Hospital, Türkiye. All information will be collected during a single assessment visit.
The findings may help clarify how patient-reported symptoms and clinical nociplastic pain criteria relate to one another and whether
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Cervical Myofascial Pain Syndrome Group | – | –Adults aged 18 years or older diagnosed with chronic cervical myofascial pain syndrome and experiencing neck pain for more than three months. Participants will undergo a single-visit clinical assessment based on the International Association for the Study of Pain (IASP) nociplastic pain criteria, followed by the Neck Disability Index (NDI), Central Sensitization Inventory (CSI), and Revised Illness Perception Questionnaire (IPQ-R). Pain severity and demographic and clinical characteristics will also be recorded. CSI and IASP classifications will be compared to assess agreement and disagreement. No experimental treatment or additional invasive procedures will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 150 adults aged 18 years or older diagnosed with chronic cervical myofascial pain syndrome who attend the Physical Medicine and Rehabilitation Outpatient Clinic at Mardin Training and Research Hospital, Türkiye. Eligible participants will have neck pain lasting longer than three months. All participants will undergo a single-visit assessment including IASP clinical nociplastic pain classification, the Central Sensitization Inventory (CSI), the Neck Disability Index (NDI), and the Revised Illness Perception Questionnaire (IPQ-R). Patients will be categorized according to their CSI and IASP classifications. No healthy control group will be included.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Neck pain lasting longer than three months.
- Diagnosis of chronic cervical myofascial pain syndrome established by a Physical Medicine and Rehabilitation specialist.
- Willingness to participate and provision of written informed consent.
Key exclusion criteria (5 listed)
- Cervical radiculopathy, myelopathy, or another neurological disorder identified as the primary cause of neck pain.
- Fracture, infection, malignancy, or active inflammatory rheumatic disease explaining the neck pain.
- Diagnosis of fibromyalgia.
- Open wounds, active skin disease, or infection in the examination area that prevents clinical assessment.
- Cognitive impairment or an active severe psychiatric condition that prevents understanding the questions, providing reliable responses, or participating in the clinical examination.
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
Agreement Between CSI and IASP Nociplastic Pain Classifications
Time frame: baseline
Agreement between the Central Sensitization Inventory (CSI) and the International Association for the Study of Pain (IASP) clinical nociplastic pain classification will be quantified using Cohen's kappa coefficient with a 95% confidence interval. CSI scores will be categorized as below 40 or 40 and above. IASP classifications will be dichotomized as not meeting the criteria or meeting the criteria for at least possible nociplastic pain (possible or probable). Cohen's kappa ranges from -1 to 1, with 1 indicating perfect agreement, 0 indicating agreement expected by chance, and negative values indicating less agreement than expected by chance.
5 secondary outcomes
Overall Discordance Rate Between CSI and IASP Classifications
Time frame: baseline
Discordance Rate for CSI-Positive and IASP-Negative Classification
Time frame: baseline
Discordance Rate for CSI-Negative and IASP-Positive Classification
Time frame: baseline
Differences in IPQ-R Emotional Representations Scores Across CSI-IASP Classification Groups
Time frame: baseline
Agreement Between CSI Classification and Probable IASP Nociplastic Pain
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 36983849Fernandez-de-Las-Penas C, Nijs J, Cagnie B, Gerwin RD, Plaza-Manzano G, Valera-Calero JA, Arendt-Nielsen L. Myofascial Pain Syndrome: A Nociceptive Condition Comorbid with Neuropathic or Nociplastic Pain. Life (Basel). 2023 Mar 3;13(3):694. doi: 10.3390/life13030694.
- Background: PubMed 23490634Neblett R, Cohen H, Choi Y, Hartzell MM, Williams M, Mayer TG, Gatchel RJ. The Central Sensitization Inventory (CSI): establishing clinically significant values for identifying central sensitivity syndromes in an outpatient chronic pain sample. J Pain. 2013 May;14(5):438-45. doi: 10.1016/j.jpain.2012.11.012. Epub 2013 Mar 13.
- Background: PubMed 33974577Kosek E, Clauw D, Nijs J, Baron R, Gilron I, Harris RE, Mico JA, Rice ASC, Sterling M. Chronic nociplastic pain affecting the musculoskeletal system: clinical criteria and grading system. Pain. 2021 Nov 1;162(11):2629-2634. doi: 10.1097/j.pain.0000000000002324. No abstract available.
- 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.
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 Myofascial Pain Syndrome - Neck, run by Mardin Artuklu 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 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taha Y YILDIRIM, M.D. (+90 534 220 77 17, tyasinyildirim.ftr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between CSI and IASP Nociplastic Pain Classifications (time frame: baseline). 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 NCT07904364, which also lists 3 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 29 Oct 2026.