Chronic Low Back PainRAPNCT05103475
Rage Against the Pain to Address Chronic Low Back Pain Among Veterans
A study testing Rage Against the Pain (RAP) in people with Chronic Low Back Pain, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Chronic low back pain is a leading cause of disability among Veterans. Yoga is recommended as a front-line treatment option for chronic low back pain and is available across the VA healthcare system; however, despite yoga being the most widely adopted of VHA's Complementary and Integrative Health (CIH) therapies… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Rage Against the Pain (RAP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Veterans will be eligible to participate in the study if they:
- currently receive primary care services at the Hines VA
- received a diagnosis associated with chronic low back pain in the previous 3 months
Who cannot join
- Veterans will be ineligible to participate in the study if any of the following are true for them:
- they currently regularly participate in yoga
- they regularly participated in yoga in the previous 6 months
- their back pain is a symptom of a specific treatable or underlying disease/condition(s), e.g.,
- ankylosing spondylitis
- active or recent malignancy
Show all 17Show fewer
- fracture/spinal cord injury
- spinal infection)
- they are experiencing progressive neurological deficits
- they have any other condition which results in severe disability, e.g.,
- non-ambulatory
- hemiparesis
- severe cognitive deficits
- they have a diagnosis associated with psychosis
- they are currently experiencing issues around substance abuse (not including prescription opioids), as identified through ICD-10 codes associated with 'mental and behavioral disorders due to psychoactive substance use' recorded in the patient's medical record in the previous 3 months
- they do not plan to be living in the Chicagoland area for the duration of the study
- they are pregnant at the time of screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
About this study
Official title: Rage Against the Pain: An Alternative Yoga Program to Address Chronic Low Back Pain Among Veterans
Chronic low back pain is a leading cause of disability among Veterans. Yoga is recommended as a front-line treatment option for chronic low back pain and is available across the VA healthcare system; however, despite yoga being the most widely adopted of VHA's Complementary and Integrative Health (CIH) therapies, Veteran participation in yoga still remains limited. Although it can be effective in managing pain, individuals cannot reap the benefits of yoga if they are unwilling to adopt it. One potential barrier to adoption of yoga among Veterans may be their perceptions of yoga, which for some, encompass long-held but perhaps inaccurate beliefs of what the practice entails and how their participation will be viewed by others. The goal of this study was to develop and evaluate an alternative-to-yoga program intended to improve Veteran participation and by extension, outcomes among Veterans with chronic low back pain. Based on Veteran input, we called this yoga program Rage Against the Pain (RAP) 'High Intensity Stretching'.
Read the detailed description
Background: Chronic low back pain is a leading cause of disability among Veterans. Yoga is recommended as a front-line treatment option for chronic low back pain and is available across the Veterans Health Administration (VHA) healthcare system; however, despite yoga being the most widely adopted of VHA's Complementary and Integrative Health (CIH) therapies, Veteran participation in yoga still remains limited. Although it can be effective in managing pain, individuals cannot reap the benefits of yoga if they are unwilling to adopt it. One potential barrier to adoption of yoga among Veterans may be their perceptions of yoga, which for some, encompass long-held but perhaps inaccurate beliefs of what the practice entails and how their participation will be viewed by others. The goal of this study was to to develop and evaluate an alternative-to-yoga program intended to improve Veteran participation and by extension, outcomes among Veterans with chronic low back pain. Based on Veteran input, we called this yoga program Rage Against the Pain (RAP) 'High Intensity Stretching'.
Significance/Impact: The RAP program is an innovative approach to address a top priority of the VHA - using CIH therapies for pain management. The long-term goal of this work is to develop a scalable and sustainable alternative-to-yoga program for Veterans with chronic pain.
Innovation: The RAP program comprises an expressive, active practice set to music commonly enjoyed among many Veterans (e.g., rock, metal). The development of RAP (and the program name) reflects direct Veteran feedback.
Specific Aims: The Specific Aims of this project were to: (1) Develop the RAP program, which encompassed finalizing the program curriculum, including music play-lists, cues for self-expression, and sets of body positions that may be beneficial for low back pain; (2) Examine the feasibility and acceptability of offering RAP for Veterans with chronic low back pain, and; (3) Gather preliminary data to provide the foundation for process, sample size and power considerations for a future clinical trial to examine the effectiveness of RAP on Veterans' outcomes and medication use.
Methodology: We first developed the RAP program, including a home practice manual, sets of body positions, music playlists, and scripts to translate Sanskrit cuing to plain language. We then conducted a single-site pilot randomized controlled trial with two cohorts of 18 Veterans each (n=36). We randomized Veterans to the intervention (RAP) or control (Hatha yoga) group. Each cohort spanned 12 weekly one-hour sessions. We collected baseline (n=36) and follow-up (n=26) survey data and completed semi-structured interviews with a subset of survey respondents (n=20). Survey data were analyzed using bivariate comparisons. Interview transcripts were independently coded by two qualitative experts and analyzed using thematic coding techniques.
Implementation/Next Steps: We intend to conduct a larger multi-site trial of the RAP program to examine its effectiveness and issues associated with its implementation.
- Conditions
- Chronic Low Back Pain
- Being tested
- Rage Against the Pain (RAP), Control
- Keywords
- Chronic low back pain, Yoga, Veterans, Complementary and integrative health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rage Against the Pain (RAP)Behavioural
The sets of body positions used in the RAP program will mirror those used in the Hatha Yoga classes, but the RAP program will differ from this traditional yoga practice in a number of ways: (1) the classes will be set to rock/heavy metal music; (2) meditation will not be incorporated; (3) yoga terms will not be used to describe the body positions (rather, positions will be cued in plain descriptive English terms); (4) the culminating activity for the class will be called a 'cool down' (rather than the savasana exercise typically used in yoga practice).
ControlBehavioural
Also called Yoga
The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them.
| Study group | Role | What they receive |
|---|---|---|
| Rage Against the Pain (RAP) | Experimental | The sets of body positions used in the RAP program will mirror those used in the Hatha Yoga classes, but the RAP program will differ from this traditional yoga practice in a number of ways: (1) the classes will be set to rock/heavy metal music; (2) meditation will not be incorporated; (3) yoga terms will not be used to describe the body positions (rather, positions will be cued in plain descriptive English terms); (4) the culminating activity for the class will be called a 'cool down' (rather than the savasana exercise typically used in yoga practice). Receives: Behavioral: Rage Against the Pain (RAP) |
| Control | Active comparator | The control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Initiation (e.g., Reach)
Program initiation (e.g., reach) will be defined as the number of individuals who start the RAP or Hatha yoga programs after being screened, deemed eligible for participation, and randomized to one or the other.
Measured: Baseline (following randomization)
Program Participation (e.g., Sustained Engagement) - Average Number of Classes Attended
Program participation (e.g., sustained engagement) - average number of classes attended; this will be defined as the average number of classes Veterans attended for each respective program.
Measured: Post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Program Participation (e.g., Sustained Engagement) - Number of Veterans Who Attend Majority of Classes
Program participation (e.g., sustained engagement) - number of Veterans who attend majority of classes; this will be defined as the number of Veterans who attended the majority (9/12) of classes.
Measured: Post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Secondary outcomes (9)
Pain Intensity
Pain intensity will be measured using the Defense and Veterans Pain Rating Scale, a valid and reliable numeric rating scale that asks individuals to report the average intensity of their low back pain on a scale of 0 (no pain) to 10 (worst pain imaginable) for the previous 7 days.
Measured: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Pain Interference
Pain interference (how much the individual's pain has interfered with all aspects of their life in the prior 7 days) will be measured using the validated, reliable Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item pain interference short form. PROMIS scores are standardized to reflect the general adult US population, such that a mean score of 50 reflects the population mean (with a standard deviation of 10), and higher scores indicate greater levels of pain interference.
Measured: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Back Pain-related Function
Back pain-related function will be measured using the Roland-Morris Disability Questionnaire (RMDQ), a valid and reliable scale of physical disability resulting from chronic low back pain. The RMDQ asks individuals to read 24 items noting back pain-related functional impairments and mark those that describe them. All marked items are summed for a total score ranging from 0 (no impairment) to 24 (maximum impairment).
Measured: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Sleep
Sleep will be measured using the Insomnia Severity Index, which is a valid and reliable 7-item scale that produces a composite score of an individual's level of sleep disturbance during the past 14 days. Item responses are added to obtain a total scale score (range: 0-28); greater scores indicate more disturbed sleep and cut-points are provided by the scale developers that map to levels of clinical severity of sleep disturbance.
Measured: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Depression
Depression severity will be measured using the 8-item Patient Health Questionnaire (PHQ-8), a valid and reliable measure that assesses individual's depression severity by asking them to evaluate 8 items that reflect symptoms of depression and indicate how often they have experienced each in the prior two weeks on a scale of 0 to 3 (not at all - nearly every day). Scores range from 0 (no depression symptomology) to 24 (most severe symptomology); scores can also be classified into mild, moderate, moderately severe and severe categories using cut-scores defined by the scale developers.
Measured: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Stress
Stress will be measured using the Perceived Stress Scale (PSS) - 4 Item, a valid and reliable measure of individual's perceptions of how stressful their life experiences are. The PSS is comprised of 4 questions and produces a composite score of perceived stress (range: 0-16; higher scores indicate higher perceptions of stress).
Measured: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Use of Other Pain Management Strategies
The investigators will ask participants to self-report use of other pain management activities.
Measured: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Perceptions of the Program
The investigators will ask participants about their perceptions of the program (extent to which they liked it, would participate again, would recommend to a peer, felt it impacted their health and how).
Measured: Post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Pain Medication Use
The investigators will ask participants to self-report any pain medication use.
Measured: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start15 Aug 2022
- Primary completion2 May 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be randomly assigned to the RAP or control (Hatha yoga) group.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Bella Etingen, PhD MA BS, Principal investigator, Edward Hines Jr. VA Hospital, Hines, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103475
- Sponsor's protocol ID
- PPO 19-362
- Acronym
- RAP
- Status last verified
- Aug 2024
- First submitted
- 1 Oct 2021
- Last updated
- 5 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rage Against the Pain: An Alternative Yoga Program to Address Chronic Low Back Pain Among Veterans
- ClinicalTrials.gov ID
- NCT05103475
- Acronym / sponsor ID
- RAP / PPO 19-362
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic low back pain, Yoga, Veterans, Complementary and integrative health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Posted 5 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic low back pain is a leading cause of disability among Veterans. Yoga is recommended as a front-line treatment option for chronic low back pain and is available across the VA healthcare system; however, despite yoga being the most widely adopted of VHA's Complementary and Integrative Health (CIH) therapies, Veteran participation in yoga still remains limited. Although it can be effective in managing pain, individuals cannot reap the benefits of yoga if they are unwilling to adopt it. One potential barrier to adoption of yoga among Veterans may be their perceptions of yoga, which for some, encompass long-held but perhaps inaccurate beliefs of what the practice entails and how their participation will be viewed by others. The goal of this study was to develop and evaluate an alternative-to-yoga program intended to improve Veteran participation and by extension, outcomes among Veterans with chronic low back pain. Based on Veteran input, we called this yoga program Rage Against the Pain (RAP) 'High Intensity Stretching'.
Detailed description
Background: Chronic low back pain is a leading cause of disability among Veterans. Yoga is recommended as a front-line treatment option for chronic low back pain and is available across the Veterans Health Administration (VHA) healthcare system; however, despite yoga being the most widely adopted of VHA's Complementary and Integrative Health (CIH) therapies, Veteran participation in yoga still remains limited. Although it can be effective in managing pain, individuals cannot reap the benefits of yoga if they are unwilling to adopt it. One potential barrier to adoption of yoga among Veterans may be their perceptions of yoga, which for some, encompass long-held but perhaps inaccurate beliefs of what the practice entails and how their participation will be viewed by others. The goal of this study was to to develop and evaluate an alternative-to-yoga program intended to improve Veteran participation and by extension, outcomes among Veterans with chronic low back pain. Based on Veteran input, we called this yoga program Rage Against the Pain (RAP) 'High Intensity Stretching'.
Significance/Impact: The RAP program is an innovative approach to address a top priority of the VHA - using CIH therapies for pain management. The long-term goal of this work is to develop a scalable and sustainable alternative-to-yoga program for Veterans with chronic pain.
Innovation: The RAP program comprises an expressive, active practice set to music commonly enjoyed among many Veterans (e.g., rock, metal). The development of RAP (and the program name) reflects direct Veteran feedback.
Specific Aims: The Specific Aims of this project were to: (1) Develop the RAP program, which encompassed finalizing the program curriculum, including music play-lists, cues for self-expression, and sets of body positions that may be beneficial for low back pain; (2) Examine the feasibility and acceptability of offering RAP for Veterans with chronic low back pain, and; (3) Gather preliminary data to provide the foundation for process, sample size and power considerations for a future clinical trial to examine the effectiveness of RAP on Veterans' outcomes and medication use.
Methodology: We first developed the RAP program, including a home practice manual, sets of body positions, music playlists, and scripts to translate Sanskrit cuing to plain language. We then conducted a single-site pilot randomized controlled trial with two cohorts of 18 Veterans each (n=36). We randomized Veterans to the intervention (RAP) or control (Hatha yoga) group. Each cohort spanned 12 weekly one-hour sessions. We collected baseline (n=36) and follow-up (n=26) survey data and completed semi-structured interviews with a subset of survey respondents (n=20). Survey data were analyzed using bivariate comparisons. Interview transcripts were independently coded by two qualitative experts and analyzed using thematic coding techniques.
Implementation/Next Steps: We intend to conduct a larger multi-site trial of the RAP program to examine its effectiveness and issues associated with its implementation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients will be randomly assigned to the RAP or control (Hatha yoga) group.
| Arm | Type | Receives |
|---|---|---|
| Rage Against the Pain (RAP) | Experimental | Behavioral: Rage Against the Pain (RAP)The sets of body positions used in the RAP program will mirror those used in the Hatha Yoga classes, but the RAP program will differ from this traditional yoga practice in a number of ways: (1) the classes will be set to rock/heavy metal music; (2) meditation will not be incorporated; (3) yoga terms will not be used to describe the body positions (rather, positions will be cued in plain descriptive English terms); (4) the culminating activity for the class will be called a 'cool down' (rather than the savasana exercise typically used in yoga practice). |
| Control | Active comparator | Behavioral: ControlThe control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- currently receive primary care services at the Hines VA
- received a diagnosis associated with chronic low back pain in the previous 3 months
Key exclusion criteria (17 listed)
- Veterans will be ineligible to participate in the study if any of the following are true for them:
- they currently regularly participate in yoga
- they regularly participated in yoga in the previous 6 months
- their back pain is a symptom of a specific treatable or underlying disease/condition(s), e.g.,
- they are experiencing progressive neurological deficits
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 |
|---|---|---|
| Rage Against the Pain (RAP)The sets of body positions used in the RAP program will mirror those used in the Hatha Yoga classes, but the RAP program will differ from this traditional yoga practice in a number of ways: (1) the classes will be set to rock/heavy metal music; (2) meditation will not be incorporated; (3) yoga terms will not be used to describe the body positions (rather, positions will be cued in plain descriptive English terms); (4) the culminating activity for the class will be called a 'cool down' (rather than the savasana exercise typically used in yoga practice). | Behavioural | Rage Against the Pain (RAP) |
| ControlAlso: YogaThe control group will comprise a program akin to Hatha yoga with chair modifications available to all Veterans who choose/need to use them. | Behavioural | Control |
Primary outcome
Program Initiation (e.g., Reach)
Time frame: Baseline (following randomization)
Program initiation (e.g., reach) will be defined as the number of individuals who start the RAP or Hatha yoga programs after being screened, deemed eligible for participation, and randomized to one or the other.
Program Participation (e.g., Sustained Engagement) - Average Number of Classes Attended
Time frame: Post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Program participation (e.g., sustained engagement) - average number of classes attended; this will be defined as the average number of classes Veterans attended for each respective program.
Program Participation (e.g., Sustained Engagement) - Number of Veterans Who Attend Majority of Classes
Time frame: Post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Program participation (e.g., sustained engagement) - number of Veterans who attend majority of classes; this will be defined as the number of Veterans who attended the majority (9/12) of classes.
9 secondary outcomes
Pain Intensity
Time frame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Pain Interference
Time frame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Back Pain-related Function
Time frame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Sleep
Time frame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Depression
Time frame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Stress
Time frame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Use of Other Pain Management Strategies
Time frame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Perceptions of the Program
Time frame: Post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Pain Medication Use
Time frame: Baseline and post-intervention follow-up (within approximately 1 week of when the 12-week yoga or RAP programs are finished)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Bella Etingen, PhD MA BS principal investigator
Edward Hines Jr. VA Hospital, Hines, IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rage Against the Pain (RAP) in people with Chronic Low Back Pain, run by VA Office of Research and Development at 1 site in United States.
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 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Program Initiation (e.g., Reach) (time frame: Baseline (following randomization)). The study lists 3 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 5 Sep 2024.