Chronic Low Back Pain (CLBP)NCT07193212
How Osteopathic Treatment Affects the Leg and Foot in People With Low Back Pain
A study testing Osteopathic Manipulative Treatment in people with Chronic Low Back Pain (CLBP), run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.
Trial summary
This pilot study will examine whether osteopathic manipulative treatment (OMT) can improve both physical and psychological aspects of chronic low back pain by focusing on the interconnected myofascial system of the back, legs, and feet. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- Osteopathic Manipulative Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2025to Dec 2026
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female subjects 18-65 years old
- presence of chronic low back > 3 months duration or pain present > 50% of the time within the previous 12 months
Who cannot join
- prior surgery of the thoracic, lumbar or sacral spine, pelvis
- diagnosis lumbar radiculopathy or pinched nerve in the neck
- diagnosis of foot condition that alters gait
- diagnosis of connective tissue or muscle disorders
- diagnosis of cancer
- previous spinal cord injury inflammatory arthritis and fibromyalgia
Show all 13Show fewer
- pregnancy
- tobacco use
- known diabetes or prediabetes
- allergy to ultrasound gel (propylene glycol)
- history of manual therapy treatment within the past 2 weeks
- injection for pain within the past 1 month
- currently taking muscle relaxers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Edward Via College of Osteopathic Medicine
Auburn, Alabama, 36832
Daniel Cawley, DC, MS, MSHS, 334-442-4105, dcawley@vcom.edu
About this study
Official title: Osteopathic Manipulation Treatment Effect on the Leg and Foot Myofascial System in Adults With Chronic Low Back Pain - Pilot Study
This pilot study will examine whether osteopathic manipulative treatment (OMT) can improve both physical and psychological aspects of chronic low back pain by focusing on the interconnected myofascial system of the back, legs, and feet. Twenty adults with chronic low back pain will receive four OMT sessions over 5-7 weeks. Before and after treatment, the investigators will measure muscle stiffness with ultrasound, plantar pressure during walking with a pressure plate, and patient-reported outcomes on pain, disability, sleep quality, stress, anxiety, depression, pain catastrophizing, and pain self-efficacy using surveys. By linking these objective and subjective measures, the study aims to provide early evidence of how OMT may influence musculoskeletal function, daily activity, and overall well-being, helping to guide future larger studies on treatment strategies for low back pain
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- Osteopathic Manipulative Treatment
- Keywords
- chronic low back pain, myofascial systems, omt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentOther
Osteopathic Manipulative Treatment (OMT) is a hands-on approach where a trained physician uses techniques such as gentle pressure, stretching, and guided movements to improve mobility, reduce pain, and support the body's natural healing. It focuses on the interconnectedness of muscles, joints, and fascia to restore balance and function.
| Study group | Role | What they receive |
|---|---|---|
| OMT Treatment Group | Experimental | Not described Receives: Other: Osteopathic Manipulative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stiffness of Low Back and Lower Extremity Muscles Assessed by Ultrasound Shear Wave Elastography
Stiffness in the muscles of the low back and lower extremity will be quantitatively assessed using ultrasound shear wave elastography (SWE). SWE provides a non-invasive, reliable measure of tissue stiffness by calculating the shear wave speed (in meters/second) and corresponding elasticity modulus (in kilopascals). Regions of interest will be placed within target muscles and tissues (e.g., lumbar multifidus, thoracolumbar aponeurosis, hamstrings, gastrocnemius) and standardized acquisition protocols will be used to ensure reproducibility. This method allows for objective measurement of muscle stiffness rather than relying on subjective evaluation, thereby enhancing the validity of the outcome measure.
Measured: From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.
Body sway normalized path length, area, and velocity.
A triaxial accelerometer will be used to measure postural control. The sensor will be secured over the lower trunk and measurements will occur under six conditions: feet together eyes open, feet together eyes closed, single-leg stance on the right and left with eyes opened and eyes closed. An average of 3 trials per condition will be used for each stance with 1 minute rest between trials. Double leg stance trials will be performed for 30 seconds while single leg stance trials will be performed for 15 seconds. Normalized path length (NPL) of acceleration in the anteroposterior (AP) and mediolateral (ML) directions, and sway excursion area, and velocity will be determined.
Measured: From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.
Secondary outcomes (4)
Low back pain intensity and frequency.
Low back and lower extremity pain intensity, and frequency measured by an NRS (intensity) and Likert scale (frequency).
Measured: From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.
Functional disability.
The Roland-Morris Disability Questionnaire will be used to score functional disability.
Measured: From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.
Plantar Pressure Changes Assessed by EMED Pedobarographic Platform
Plantar pressure distribution will be assessed using a validated EMED pedobarographic platform (Novel), which records dynamic foot pressures during gait. Outcome parameters will include peak pressure (kPa), pressure-time integrals, and center of pressure trajectory. Participants will walk barefoot at a self-selected pace across the platform, and standardized protocols will be used to ensure reproducibility. An average of 5 measures from each foot will be obtained.
Measured: From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.
Pain self-efficacy score
The pain self-efficacy questionnaire will be used to assess participants confidence in their ability to perform various activities and achieve goals despite experiencing pain, and its relationship to clinical response to treatment.
Measured: From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start5 Nov 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back Pain (CLBP)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edward Via Virginia College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Cawley, DC, MS, MSHS, Principal investigator, VCOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193212
- Sponsor's protocol ID
- 2024-206
- Status last verified
- Nov 2025
- First submitted
- 8 Sep 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berenshteyn Y, Gibson K, Hackett GC, Trem AB, Wilhelm M. Is standing balance altered in individuals with chronic low back pain? A systematic review. Disabil Rehabil. 2019 Jun;41(13):1514-1523. doi: 10.1080/09638288.2018.1433240. Epub 2018 Jan 30.
PubMed 29382241Wang H, Zheng J, Fan Z, Luo Z, Wu Y, Cheng X, Yang J, Zhang S, Yu Q, Lo WLA, Wang C. Impaired static postural control correlates to the contraction ability of trunk muscle in young adults with chronic non-specific low back pain: A cross-sectional study. Gait Posture. 2022 Feb;92:44-50. doi: 10.1016/j.gaitpost.2021.11.021. Epub 2021 Nov 19.
PubMed 34823100Park J, Nguyen VQ, Ho RLM, Coombes SA. The effect of chronic low back pain on postural control during quiet standing: A meta-analysis. Sci Rep. 2023 May 16;13(1):7928. doi: 10.1038/s41598-023-34692-w.
PubMed 37193730Ruhe A, Fejer R, Walker B. Is there a relationship between pain intensity and postural sway in patients with non-specific low back pain? BMC Musculoskelet Disord. 2011 Jul 15;12:162. doi: 10.1186/1471-2474-12-162.
PubMed 21762484Ryum T, Stiles TC. Changes in pain catastrophizing, fear-avoidance beliefs, and pain self-efficacy mediate changes in pain intensity on disability in the treatment of chronic low back pain. Pain Rep. 2023 Sep 13;8(5):e1092. doi: 10.1097/PR9.0000000000001092. eCollection 2023 Sep.
PubMed 37719924Ogunlana MO, Odole AC, Adejumo A, Odunaiya N. Catastrophising, pain, and disability in patients with nonspecific low back pain. Hong Kong Physiother J. 2015 Dec;33(2):73-79. doi: 10.1016/j.hkpj.2015.03.001. Epub 2015 Apr 16.
PubMed 30930571Xu C, Fu Z, Wang J, Wu B, Wang XQ. Differences and Correlations of Anxiety, Sleep Quality, and Pressure-Pain Threshold between Patients with Chronic Low Back Pain and Asymptomatic People. Pain Res Manag. 2022 May 17;2022:8648584. doi: 10.1155/2022/8648584. eCollection 2022.
PubMed 35619991Nguyen C, Boutron I, Zegarra-Parodi R, Baron G, Alami S, Sanchez K, Daste C, Boisson M, Fabre L, Krief P, Krief G, Lefevre-Colau MM, Rannou F. Effect of Osteopathic Manipulative Treatment vs Sham Treatment on Activity Limitations in Patients With Nonspecific Subacute and Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2021 May 1;181(5):620-630. doi: 10.1001/jamainternmed.2021.0005.
PubMed 33720272Murillo C, Falla D, Rushton A, Sanderson A, Heneghan NR. Shear wave elastography investigation of multifidus stiffness in individuals with low back pain. J Electromyogr Kinesiol. 2019 Aug;47:19-24. doi: 10.1016/j.jelekin.2019.05.004. Epub 2019 May 3.
PubMed 31077992Menz HB, Dufour AB, Riskowski JL, Hillstrom HJ, Hannan MT. Foot posture, foot function and low back pain: the Framingham Foot Study. Rheumatology (Oxford). 2013 Dec;52(12):2275-82. doi: 10.1093/rheumatology/ket298. Epub 2013 Sep 17.
PubMed 24049103McClinton S, Weber CF, Heiderscheit B. Low back pain and disability in individuals with plantar heel pain. Foot (Edinb). 2018 Mar;34:18-22. doi: 10.1016/j.foot.2017.09.003. Epub 2017 Sep 28.
PubMed 29202429Loffler M, Schneider P, Schuh-Hofer S, Kamping S, Usai K, Treede RD, Nees F, Flor H. Stress-induced hyperalgesia instead of analgesia in patients with chronic musculoskeletal pain. Neurobiol Pain. 2022 Dec 6;13:100110. doi: 10.1016/j.ynpai.2022.100110. eCollection 2023 Jan-Jul.
PubMed 36561877Licciardone JC, Gatchel RJ, Aryal S. Recovery From Chronic Low Back Pain After Osteopathic Manipulative Treatment: A Randomized Controlled Trial. J Am Osteopath Assoc. 2016 Mar;116(3):144-55. doi: 10.7556/jaoa.2016.031.
PubMed 26927908Anukoolkarn K, Vongsirinavarat M, Bovonsunthonchai S, Vachalathiti R. Plantar Pressure Distribution Pattern during Mid-Stance Phase of the Gait in Patients with Chronic Non-Specific Low Back Pain. J Med Assoc Thai. 2015 Sep;98(9):896-901.
PubMed 26591401Alsaadi SM, McAuley JH, Hush JM, Maher CG. Prevalence of sleep disturbance in patients with low back pain. Eur Spine J. 2011 May;20(5):737-43. doi: 10.1007/s00586-010-1661-x. Epub 2010 Dec 29.
PubMed 21190045
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulation Treatment Effect on the Leg and Foot Myofascial System in Adults With Chronic Low Back Pain - Pilot Study
- ClinicalTrials.gov ID
- NCT07193212
- Acronym / sponsor ID
- 2024-206
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- chronic low back pain, myofascial systems, omt
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Edward Via Virginia College of Osteopathic MedicineUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Sep 2025 (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 pilot study will examine whether osteopathic manipulative treatment (OMT) can improve both physical and psychological aspects of chronic low back pain by focusing on the interconnected myofascial system of the back, legs, and feet. Twenty adults with chronic low back pain will receive four OMT sessions over 5-7 weeks. Before and after treatment, the investigators will measure muscle stiffness with ultrasound, plantar pressure during walking with a pressure plate, and patient-reported outcomes on pain, disability, sleep quality, stress, anxiety, depression, pain catastrophizing, and pain self-efficacy using surveys. By linking these objective and subjective measures, the study aims to provide early evidence of how OMT may influence musculoskeletal function, daily activity, and overall well-being, helping to guide future larger studies on treatment strategies for low back pain
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OMT Treatment Group | Experimental | Other: Osteopathic Manipulative Treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male and female subjects 18-65 years old
- presence of chronic low back > 3 months duration or pain present > 50% of the time within the previous 12 months
Key exclusion criteria (13 listed)
- prior surgery of the thoracic, lumbar or sacral spine, pelvis
- diagnosis lumbar radiculopathy or pinched nerve in the neck
- diagnosis of foot condition that alters gait
- diagnosis of connective tissue or muscle disorders
- diagnosis of cancer
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 |
|---|---|---|
| Osteopathic Manipulative TreatmentOsteopathic Manipulative Treatment (OMT) is a hands-on approach where a trained physician uses techniques such as gentle pressure, stretching, and guided movements to improve mobility, reduce pain, and support the body's natural healing. It focuses on the interconnectedness of muscles, joints, and fascia to restore balance and function. | Other | OMT Treatment Group |
Primary outcome
Stiffness of Low Back and Lower Extremity Muscles Assessed by Ultrasound Shear Wave Elastography
Time frame: From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.
Stiffness in the muscles of the low back and lower extremity will be quantitatively assessed using ultrasound shear wave elastography (SWE). SWE provides a non-invasive, reliable measure of tissue stiffness by calculating the shear wave speed (in meters/second) and corresponding elasticity modulus (in kilopascals). Regions of interest will be placed within target muscles and tissues (e.g., lumbar multifidus, thoracolumbar aponeurosis, hamstrings, gastrocnemius) and standardized acquisition protocols will be used to ensure reproducibility. This method allows for objective measurement of muscle stiffness rather than relying on subjective evaluation, thereby enhancing the validity of the outcome measure.
Body sway normalized path length, area, and velocity.
Time frame: From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.
A triaxial accelerometer will be used to measure postural control. The sensor will be secured over the lower trunk and measurements will occur under six conditions: feet together eyes open, feet together eyes closed, single-leg stance on the right and left with eyes opened and eyes closed. An average of 3 trials per condition will be used for each stance with 1 minute rest between trials. Double leg stance trials will be performed for 30 seconds while single leg stance trials will be performed for 15 seconds. Normalized path length (NPL) of acceleration in the anteroposterior (AP) and mediolateral (ML) directions, and sway excursion area, and velocity will be determined.
4 secondary outcomes
Low back pain intensity and frequency.
Time frame: From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.
Functional disability.
Time frame: From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.
Plantar Pressure Changes Assessed by EMED Pedobarographic Platform
Time frame: From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.
Pain self-efficacy score
Time frame: From baseline measures on Day 1 until one week after the last OMT treatment, up to 7 weeks.
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 14 May 2026.
- Background: PubMed 29382241Berenshteyn Y, Gibson K, Hackett GC, Trem AB, Wilhelm M. Is standing balance altered in individuals with chronic low back pain? A systematic review. Disabil Rehabil. 2019 Jun;41(13):1514-1523. doi: 10.1080/09638288.2018.1433240. Epub 2018 Jan 30.
- Background: PubMed 34823100Wang H, Zheng J, Fan Z, Luo Z, Wu Y, Cheng X, Yang J, Zhang S, Yu Q, Lo WLA, Wang C. Impaired static postural control correlates to the contraction ability of trunk muscle in young adults with chronic non-specific low back pain: A cross-sectional study. Gait Posture. 2022 Feb;92:44-50. doi: 10.1016/j.gaitpost.2021.11.021. Epub 2021 Nov 19.
- Background: PubMed 37193730Park J, Nguyen VQ, Ho RLM, Coombes SA. The effect of chronic low back pain on postural control during quiet standing: A meta-analysis. Sci Rep. 2023 May 16;13(1):7928. doi: 10.1038/s41598-023-34692-w.
- Background: PubMed 21762484Ruhe A, Fejer R, Walker B. Is there a relationship between pain intensity and postural sway in patients with non-specific low back pain? BMC Musculoskelet Disord. 2011 Jul 15;12:162. doi: 10.1186/1471-2474-12-162.
- Background: PubMed 37719924Ryum T, Stiles TC. Changes in pain catastrophizing, fear-avoidance beliefs, and pain self-efficacy mediate changes in pain intensity on disability in the treatment of chronic low back pain. Pain Rep. 2023 Sep 13;8(5):e1092. doi: 10.1097/PR9.0000000000001092. eCollection 2023 Sep.
- Background: PubMed 30930571Ogunlana MO, Odole AC, Adejumo A, Odunaiya N. Catastrophising, pain, and disability in patients with nonspecific low back pain. Hong Kong Physiother J. 2015 Dec;33(2):73-79. doi: 10.1016/j.hkpj.2015.03.001. Epub 2015 Apr 16.
- Background: PubMed 35619991Xu C, Fu Z, Wang J, Wu B, Wang XQ. Differences and Correlations of Anxiety, Sleep Quality, and Pressure-Pain Threshold between Patients with Chronic Low Back Pain and Asymptomatic People. Pain Res Manag. 2022 May 17;2022:8648584. doi: 10.1155/2022/8648584. eCollection 2022.
- Background: PubMed 33720272Nguyen C, Boutron I, Zegarra-Parodi R, Baron G, Alami S, Sanchez K, Daste C, Boisson M, Fabre L, Krief P, Krief G, Lefevre-Colau MM, Rannou F. Effect of Osteopathic Manipulative Treatment vs Sham Treatment on Activity Limitations in Patients With Nonspecific Subacute and Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2021 May 1;181(5):620-630. doi: 10.1001/jamainternmed.2021.0005.
- Background: PubMed 31077992Murillo C, Falla D, Rushton A, Sanderson A, Heneghan NR. Shear wave elastography investigation of multifidus stiffness in individuals with low back pain. J Electromyogr Kinesiol. 2019 Aug;47:19-24. doi: 10.1016/j.jelekin.2019.05.004. Epub 2019 May 3.
- Background: PubMed 24049103Menz HB, Dufour AB, Riskowski JL, Hillstrom HJ, Hannan MT. Foot posture, foot function and low back pain: the Framingham Foot Study. Rheumatology (Oxford). 2013 Dec;52(12):2275-82. doi: 10.1093/rheumatology/ket298. Epub 2013 Sep 17.
- Background: PubMed 29202429McClinton S, Weber CF, Heiderscheit B. Low back pain and disability in individuals with plantar heel pain. Foot (Edinb). 2018 Mar;34:18-22. doi: 10.1016/j.foot.2017.09.003. Epub 2017 Sep 28.
- Background: PubMed 36561877Loffler M, Schneider P, Schuh-Hofer S, Kamping S, Usai K, Treede RD, Nees F, Flor H. Stress-induced hyperalgesia instead of analgesia in patients with chronic musculoskeletal pain. Neurobiol Pain. 2022 Dec 6;13:100110. doi: 10.1016/j.ynpai.2022.100110. eCollection 2023 Jan-Jul.
- 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.
Daniel Cawley, DC, MS, MSHS principal investigator
VCOM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment in people with Chronic Low Back Pain (CLBP), run by Edward Via Virginia College of Osteopathic Medicine 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 2 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 14 May 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 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?
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 Daniel Cawley, DC, MS, MSHS (334-442-4105, dcawley@vcom.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stiffness of Low Back and Lower Extremity Muscles Assessed by Ultrasound Shear Wave Elastography (time frame: From baseline measures on Day 1 until the last OMT treatment, up to 6 weeks.). The study lists 2 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 NCT07193212, which also lists 15 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 14 May 2026.