Low Back PainNCT05111782
Age Bias on Biopsychosocial Factors in Persons With Non-specific Low Back Pain.
A study of Low Back Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Low back pain is a debilitating condition experienced by people of all age groups. This study will be completed in two stages in which back pain assessment tools will be first translated to Urdu language and later on age-related bias on biopsychosocial factors will be assessed using various biopsychosocial tools over… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Jun 2022to 1 Jun 2025
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both male \& Female patients
- Age group 20-60 Years
- Diagnosed with nonspecific low back pain for more than 3 months (i.e., pain localized below the costal margin and above the inferior gluteal folds with or without referred leg pain of a nociceptive mechanical nature, not attributable to a recognizable, known specific spinal pathology, for a period of at least twelve weeks)
Who cannot join
- Any serious conditions like neurological conditions which would not allow the patient to fill the questionnaire independently, any infection, tumor, spinal surgery, cognitive impairments, or any other rheumatologic disease would be excluded.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation university institute of rehabilitation sciences
Islamabad, Federal, 46000
Aamer Naeem, MS, 03229781038, aamerr.naeem@gmail.com
Aamer Naeem, MS
About this study
Low back pain is a debilitating condition experienced by people of all age groups. This study will be completed in two stages in which back pain assessment tools will be first translated to Urdu language and later on age-related bias on biopsychosocial factors will be assessed using various biopsychosocial tools over a period of six months.
Read the detailed description
Low back pain (LBP) is an extremely common symptom experienced by people of all ages. The current incidence, prevalence and disability-adjusted life years (DALYs) account for 245.9 million cases/year (15th worldwide cause; 32.4% cases associated with leg pain), 577.0 million cases (15th worldwide cause) and 64.9 million DALYs (6th worldwide cause), respectively. In recent decades, the biopsychosocial model has been applied as a framework for understanding the complexity of low back pain disability in preference to a purely biomedical approach. Considering the large population of patients with LBP and limited medical resources, the development of brief and efficient prognostic clinical tools for use in routine practice is particularly significant. Recent data from epidemiological studies suggest that LBP could affect the physical function of young and older individuals differently. The age-related differ¬ences in the prevalence of some low back pathologies may explain the differential treatment outcomes. The aim of the study is to explore the age bias on biopsychosocial factors in persons with non-specific low back pain.
- Conditions
- Low Back Pain
- Being tested
- Symptom Modulation Approach, Movement Control Approach, Functional Optimization Approach
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom Modulation Approach, Movement Control Approach, Functional Optimization ApproachOther
Based on the patients' symptoms and level of disability, either symptom modulation or movement control or functional optimization exercises will be used. The exercises will be provided on alternate days for a duration of 30 minutes in each session preceded by electrotherapeutic modalities for pain relief and muscle relaxation. These modalities will be given for 15 min in each session. The total no. of sessions will be based on the patient's progress for a maximum of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | The treatment group will consist of persons with low back pain. This group will be further divided into groups for each decade. Receives: Other: Symptom Modulation Approach, Movement Control Approach, Functional Optimization Approach |
| Healthy Control Group | No intervention | The control group will consist of healthy controls. This group will be further divided into groups for each decade. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
The Numeric Pain Rating Scale will be used to quantify pain intensity on a scale of 1-10. A higher score represents higher pain.
Measured: 6 months
Örebro Musculoskeletal Pain Screening Questionnaire
Screening for long term disability and failure to return to work will be done through Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ). The total score will range between 1 and 100. A higher score represents a poor outcome.
Measured: 6 months
Keele STarT Back Screening Tool
Screening for primary care patients with low back pain to look for prognostic indicators that are relevant to initial decision making will be done through Keele STarT Back Screening Tool (SBST). Scores range from 0-9 and are produced by adding all positive items; patients who achieve a score of 0-3 are classified into the low-risk subgroup and those with scores of 4-9 into the medium-risk subgroup.
Measured: 6 months
Low Back Outcome Scale
Pain \& physical function will be assessed through the Low Back Outcome Scale. The Low Back Outcome Scale ranges from 0 to 75 and the higher score indicates better condition
Measured: 6 months
Gait & Balance mobile Application
This mobile application will be used to measure the balance of the participants.
Measured: 6 months
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality and disturbances will be assessed through Pittsburgh Sleep Quality Index (PSQI). The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The sub-scores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.
Measured: 6 months
Center for Epidemiological Studies-Depression Scale (CES-D)
Depression symptoms will be evaluated through CES-D. The possible range is 0-60. If more than four questions are missing answers, do not score the CES-D questionnaire. A score of 16 points or more is considered depressed. The possible range is 0-60. A score of 16 points or more is considered depressed.
Measured: 6 months
Fear Avoidance Belief Questionnaire (FABQ)
Fear of pain will be evaluated through FABQ. The score range is between 0 to 96. A higher score indicates strongly held fear-avoidance beliefs.
Measured: 6 months
Job Content Questionnaire
Psychosocial aspects related to the job will be evaluated through the Job Content Questionnaire. The items are quantified on a four-point Likert scale ranging from 1 (totally disagree) to 4 (totally agree).
Measured: 6 months
Roland Morris Disability Questionnaire (RMDQ)
Physical disability due to low back pain will be evaluated through RMDQ. The score can range from 0 to 24. A higher score indicates greater disability.
Measured: 6 months
International Physical Activity Questionnaire (IPAQ)
Physical activity levels will be assessed through IPAQ. Data collected with IPAQ will be reported as a continuous measure and reported as median METminutes. walking is considered to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. A higher score indicates higher levels of physical activity.
Measured: 6 months
Pain catastrophizing scale
Catastrophic thinking related to pain will be evaluated through the pain catastrophizing scale. It consists of 13 items scored from 0 to 4, resulting in a total possible score of 52. A higher score indicates a higher level of catastrophizing.
Measured: 6 months
Pain self-efficacy Questionnaire (PSEQ)
Confidence in dealing with pain will be evaluated through PSEQ. A raw score is presented with a range from 0 - 60, where high scores indicate greater levels of confidence in dealing with pain.
Measured: 6 months
Force Platform
Standing postural control will be assessed using Force Platform.Coordinates of Centre of Pressure will be recorded.
Measured: 6 months
Heart rate variability
Heart rate variability will be assessed through Smartwatch.
Measured: 6 months
Sleep pattern
Sleep patterns will be assessed through Smartwatch in the form of phases of sleep and duration of sleep.
Measured: 6 months
Activity level
Activity level will be assessed through Smartwatch in the form of the number of steps per day.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start13 Jun 2022
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Amjad, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111782
- Sponsor's protocol ID
- REC/1116 Aamer Naeem
- Status last verified
- Apr 2024
- First submitted
- 7 Oct 2021
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
PubMed 22231424Hartvigsen J, Christensen K, Frederiksen H. Back pain remains a common symptom in old age. a population-based study of 4486 Danish twins aged 70-102. Eur Spine J. 2003 Oct;12(5):528-34. doi: 10.1007/s00586-003-0542-y. Epub 2003 May 14.
PubMed 12748896Urits I, Burshtein A, Sharma M, Testa L, Gold PA, Orhurhu V, Viswanath O, Jones MR, Sidransky MA, Spektor B, Kaye AD. Low Back Pain, a Comprehensive Review: Pathophysiology, Diagnosis, and Treatment. Curr Pain Headache Rep. 2019 Mar 11;23(3):23. doi: 10.1007/s11916-019-0757-1.
PubMed 30854609Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
PubMed 27745712GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
PubMed 30496104Hebert JJ, Koppenhaver SL, Walker BF. Subgrouping patients with low back pain: a treatment-based approach to classification. Sports Health. 2011 Nov;3(6):534-42. doi: 10.1177/1941738111415044.
PubMed 23016055Fritz JM, Brennan GP, Clifford SN, Hunter SJ, Thackeray A. An examination of the reliability of a classification algorithm for subgrouping patients with low back pain. Spine (Phila Pa 1976). 2006 Jan 1;31(1):77-82. doi: 10.1097/01.brs.0000193898.14803.8a.
PubMed 16395181
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age Bias on Biopsychosocial Factors in Persons With Non-specific Low Back Pain.
- ClinicalTrials.gov ID
- NCT05111782
- Acronym / sponsor ID
- REC/1116 Aamer Naeem
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 8 Nov 2021 (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.
Low back pain is a debilitating condition experienced by people of all age groups. This study will be completed in two stages in which back pain assessment tools will be first translated to Urdu language and later on age-related bias on biopsychosocial factors will be assessed using various biopsychosocial tools over a period of six months.
Detailed description
Low back pain (LBP) is an extremely common symptom experienced by people of all ages. The current incidence, prevalence and disability-adjusted life years (DALYs) account for 245.9 million cases/year (15th worldwide cause; 32.4% cases associated with leg pain), 577.0 million cases (15th worldwide cause) and 64.9 million DALYs (6th worldwide cause), respectively. In recent decades, the biopsychosocial model has been applied as a framework for understanding the complexity of low back pain disability in preference to a purely biomedical approach. Considering the large population of patients with LBP and limited medical resources, the development of brief and efficient prognostic clinical tools for use in routine practice is particularly significant. Recent data from epidemiological studies suggest that LBP could affect the physical function of young and older individuals differently. The age-related differ¬ences in the prevalence of some low back pathologies may explain the differential treatment outcomes. The aim of the study is to explore the age bias on biopsychosocial factors in persons with non-specific low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Symptom Modulation Approach, Movement Control Approach, Functional Optimization ApproachThe treatment group will consist of persons with low back pain. This group will be further divided into groups for each decade. |
| Healthy Control Group | No intervention | –The control group will consist of healthy controls. This group will be further divided into groups for each decade. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both male \& Female patients
- Age group 20-60 Years
- Diagnosed with nonspecific low back pain for more than 3 months (i.e., pain localized below the costal margin and above the inferior gluteal folds with or without referred leg pain of a nociceptive mechanical nature, not attributable to a recognizable, known specific spinal pathology, for a period of at least twelve weeks)
Key exclusion criteria (1 listed)
- Any serious conditions like neurological conditions which would not allow the patient to fill the questionnaire independently, any infection, tumor, spinal surgery, cognitive impairments, or any other rheumatologic disease would be excluded.
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 |
|---|---|---|
| Symptom Modulation Approach, Movement Control Approach, Functional Optimization ApproachBased on the patients' symptoms and level of disability, either symptom modulation or movement control or functional optimization exercises will be used. The exercises will be provided on alternate days for a duration of 30 minutes in each session preceded by electrotherapeutic modalities for pain relief and muscle relaxation. These modalities will be given for 15 min in each session. The total no. of sessions will be based on the patient's progress for a maximum of 4 weeks. | Other | Treatment Group |
Primary outcome
Numeric Pain Rating Scale
Time frame: 6 months
The Numeric Pain Rating Scale will be used to quantify pain intensity on a scale of 1-10. A higher score represents higher pain.
Örebro Musculoskeletal Pain Screening Questionnaire
Time frame: 6 months
Screening for long term disability and failure to return to work will be done through Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ). The total score will range between 1 and 100. A higher score represents a poor outcome.
Keele STarT Back Screening Tool
Time frame: 6 months
Screening for primary care patients with low back pain to look for prognostic indicators that are relevant to initial decision making will be done through Keele STarT Back Screening Tool (SBST). Scores range from 0-9 and are produced by adding all positive items; patients who achieve a score of 0-3 are classified into the low-risk subgroup and those with scores of 4-9 into the medium-risk subgroup.
Low Back Outcome Scale
Time frame: 6 months
Pain \& physical function will be assessed through the Low Back Outcome Scale. The Low Back Outcome Scale ranges from 0 to 75 and the higher score indicates better condition
Gait & Balance mobile Application
Time frame: 6 months
This mobile application will be used to measure the balance of the participants.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 months
Sleep quality and disturbances will be assessed through Pittsburgh Sleep Quality Index (PSQI). The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The sub-scores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.
Center for Epidemiological Studies-Depression Scale (CES-D)
Time frame: 6 months
Depression symptoms will be evaluated through CES-D. The possible range is 0-60. If more than four questions are missing answers, do not score the CES-D questionnaire. A score of 16 points or more is considered depressed. The possible range is 0-60. A score of 16 points or more is considered depressed.
Fear Avoidance Belief Questionnaire (FABQ)
Time frame: 6 months
Fear of pain will be evaluated through FABQ. The score range is between 0 to 96. A higher score indicates strongly held fear-avoidance beliefs.
Job Content Questionnaire
Time frame: 6 months
Psychosocial aspects related to the job will be evaluated through the Job Content Questionnaire. The items are quantified on a four-point Likert scale ranging from 1 (totally disagree) to 4 (totally agree).
Roland Morris Disability Questionnaire (RMDQ)
Time frame: 6 months
Physical disability due to low back pain will be evaluated through RMDQ. The score can range from 0 to 24. A higher score indicates greater disability.
International Physical Activity Questionnaire (IPAQ)
Time frame: 6 months
Physical activity levels will be assessed through IPAQ. Data collected with IPAQ will be reported as a continuous measure and reported as median METminutes. walking is considered to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. A higher score indicates higher levels of physical activity.
Pain catastrophizing scale
Time frame: 6 months
Catastrophic thinking related to pain will be evaluated through the pain catastrophizing scale. It consists of 13 items scored from 0 to 4, resulting in a total possible score of 52. A higher score indicates a higher level of catastrophizing.
Pain self-efficacy Questionnaire (PSEQ)
Time frame: 6 months
Confidence in dealing with pain will be evaluated through PSEQ. A raw score is presented with a range from 0 - 60, where high scores indicate greater levels of confidence in dealing with pain.
Force Platform
Time frame: 6 months
Standing postural control will be assessed using Force Platform.Coordinates of Centre of Pressure will be recorded.
Heart rate variability
Time frame: 6 months
Heart rate variability will be assessed through Smartwatch.
Sleep pattern
Time frame: 6 months
Sleep patterns will be assessed through Smartwatch in the form of phases of sleep and duration of sleep.
Activity level
Time frame: 6 months
Activity level will be assessed through Smartwatch in the form of the number of steps per day.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Background: PubMed 22231424Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
- Background: PubMed 12748896Hartvigsen J, Christensen K, Frederiksen H. Back pain remains a common symptom in old age. a population-based study of 4486 Danish twins aged 70-102. Eur Spine J. 2003 Oct;12(5):528-34. doi: 10.1007/s00586-003-0542-y. Epub 2003 May 14.
- Background: PubMed 30854609Urits I, Burshtein A, Sharma M, Testa L, Gold PA, Orhurhu V, Viswanath O, Jones MR, Sidransky MA, Spektor B, Kaye AD. Low Back Pain, a Comprehensive Review: Pathophysiology, Diagnosis, and Treatment. Curr Pain Headache Rep. 2019 Mar 11;23(3):23. doi: 10.1007/s11916-019-0757-1.
- Background: PubMed 27745712Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
- Background: PubMed 30496104GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
- Background: PubMed 23016055Hebert JJ, Koppenhaver SL, Walker BF. Subgrouping patients with low back pain: a treatment-based approach to classification. Sports Health. 2011 Nov;3(6):534-42. doi: 10.1177/1941738111415044.
- Background: PubMed 16395181Fritz JM, Brennan GP, Clifford SN, Hunter SJ, Thackeray A. An examination of the reliability of a classification algorithm for subgrouping patients with low back pain. Spine (Phila Pa 1976). 2006 Jan 1;31(1):77-82. doi: 10.1097/01.brs.0000193898.14803.8a.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Imran Amjad, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Low Back Pain, run by Riphah International University at 1 site in Pakistan.
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 3 inclusion and 1 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 3 Apr 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 Pakistan. 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?
Contact Aamer Naeem, MS (+923229781038, aamerr.naeem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 6 months). The study lists 17 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 NCT05111782, which also lists 7 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 3 Apr 2024.