Chronic MigraineNCT04976985
Osteopathic Manipulative Treatment and Migraine Headaches
A study testing Osteopathic Manipulative Therapy (OMT) in people with Chronic Migraine and Migraine Disorders, run by St. Luke's Hospital, Pennsylvania at 1 site in United States.
Trial summary
In this study the investigators hypothesize, that Osteopathic Manipulative Therapy (OMT) will reduce migraine disability and severity scores when compared to standard of care including prophylactic pharmacological agents with treatment over 12 week time frame. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Migraine, Migraine Disorders, Headache Disorders
- What is being tested?
- Osteopathic Manipulative Therapy (OMT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2018to 30 Mar 2022
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-50
- Gender: Male and Female
- ICD 10 code of migraine with or without aura (G43.0, G43.1, G43.70, G43.71)
- No change in prophylactic medication for both control and intervention group
- No physical therapy for headaches, neck pain or for trapezius muscle during 12 weeks for both control and intervention group
Who cannot join
- Previous Surgery to neck or cranium, history of previous stroke
- More than two daily prophylactic pharmacologic agents used for the indication of Migraine headache
- Active cancer
- Receiving BOTOX® for migraines or treatment within the last 4 months
- If patient has contraindications for OMT for the intervention group such as clinical signs of fractures in cervical spine, ligament instability, or severe vertebral artery stenosis
- If patient is poor candidate for OMT in intervention group such as the patient is unable to follow commands.
- Seizure disorder or recent head trauma
- Pregnant or become pregnant during the treatment period
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's University Health Network
Bethlehem, Pennsylvania, 17901
About this study
Official title: The Efficacy of Osteopathic Manipulative Treatment on Decreasing the Severity of Migraine Headaches
In this study the investigators hypothesize, that Osteopathic Manipulative Therapy (OMT) will reduce migraine disability and severity scores when compared to standard of care including prophylactic pharmacological agents with treatment over 12 week time frame. The investigators aim to decrease severity and disability of migraine by utilizing Osteopathic Manipulative Therapy. This would ultimately reduce the utilization of office or emergency department visits, decrease the large economic burden the United States faces for migraine patients as well as improve quality of life for the 3 million chronic migraine patients.
Read the detailed description
According to the American Headache Society, Migraine headaches affect one billion people worldwide. In the United States, one in five women and one in sixteen men suffer from migraine headaches. Migraine is the sixth most disabling illness in the world. More than four million people have chronic daily migraines with at least 15 migraines per month. More than 90% of sufferers are unable to work or function normally during their migraine attacks. Unlike many other chronic diseases, migraine affects otherwise healthy, young and middle aged people. Headache accounts for the fourth or fifth most common reason for emergency department visits and the economic burden of migraine reaches $78 billion dollars per year.
Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, non-invasive form of manual medicine. Headache has been shown to be associated with impairment of autonomic nervous system including autonomic nuclei responsible for pain perception. It has also been shown through research that persons with a migraine episode are known to release high levels of the pro-inflammatory agents, prostaglandins, dopamine and serotonin. The effect of OMT on headache can be two fold: First, by increasing parasympathetic tone, and second, by inhibiting pro-inflammatory substances. Therefore, OMT could theoretically counter balance both the release of pro-inflammatory markers as well as the autonomic nervous system leading to improved clinical outcomes. These outcomes include: decreasing patients' severity and frequency of their migraine headache, which, ultimately could improve subjects' productivity to society and decrease the economic burden of migraine sufferers.
Historically, OMT was believed to worsen migraine headaches, this study is being conducted to learn about how Osteopathic Manipulative Therapy can help migraine patients. Subjects receiving OMT could benefit from improved quality of life by reducing subject's severity and frequency of their migraine headache, which could improve their productivity to society and decrease the economic burden of migraine headaches. This could provide information to make Osteopathic Manipulative Therapy an acknowledged alternative therapy to improve quality of life for 3 million chronic migraine sufferers.
- Being tested
- Osteopathic Manipulative Therapy (OMT), Standard of care
- Keywords
- OMT, Osteopathic Manipulative Therapy, Migraine, Headache
- Medical subject headings
- Migraine Disorders, Headache Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative Therapy (OMT)Procedure or surgery
Also called OMT
Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, noninvasive form of manual medicine. Osteopathic physicians receive special training in the musculoskeletal system to detect somatic dysfunction. Osteopathic physicians then move a patient's muscles and joints using techniques that include stretching, gentle pressure and resistance to improve muscle tonicity, treat structural abnormalities, relieve joint restriction, and decrease activation of the pain proprioception pathway.
OMT Standardized Protocol A:
- Occipital- Alanto release
- Muscle energy and soft tissue to mid trapezius muscle
- Muscle energy to cervical spine in all three planes of flexion/extension, rotation and side bending
- Screening for tender points of C2-C6 at transverse and spinous processes and treatment with counterstain if tender point identified
- Soft tissue to cervical paraspinal muscles
- Myo-fascial release of frontal forehead
- CV4 cranial technique
Standard of careOther
Receiving standard of care for migraine headaches with pharmacological medications, with no more than two prophylactic medications during the study period. Participants may also take abortive migraine medications.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group receiving Osteopathic Manipulative Therapy (OMT) | Experimental | 70 patients with chronic migraine who consent to OMT will receive four standardized osteopathic manipulative treatment protocol over the course of twelve weeks at week 0,2,6,10. MIDAS and HIT-6 Questionnaires will be obtained at time of consent prior to first treatment and again at the conclusion of treatment period of twelve weeks. Receives: Procedure: Osteopathic Manipulative Therapy (OMT) |
| Control Group with Standard of Care | Other | 70 patients with the diagnosis of migraine headache who are receiving the standard of care medications will complete a MIDAS and HIT-6 questionnaire at week 0 and week 12. A new prophylactic medication may be started at time of initial questionnaires and the patient can be on up to two prophylactic medications, with no changes during the 12 week period. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the Migraine Disability Test (MIDAS) score in the OMT interventional group compared to control group.
Reduction in the Migraine Disability Test (MIDAS) score and level of disability per the MIDAS score scoring system:
MIDAS Grade I (Little to no disability): 0-5 MIDAS Grade II(Mild Disability): 6-10 MIDAS Grade III (Moderate Disability): 11-20 MIDAS Grade IV (Severe Disability): 21+
minimum score: 0 maximum score: 21+ (no maximum)
Measured: 12 weeks
Reduction in the Headache Impact Test (HIT-6) score in OMT intervention group compared to control group.
Reduction in the Headache Impact Test (HIT-6) score per the scoring system:
Little or no impact: 49 or Less Some impact: 50-55 Substantial Impact: 56-59 Severe Impact: 60-78
minimum score: 36 Maximum score: 78
Measured: 12 weeks
Secondary outcomes (2)
Headache Days
Reduction in the number of headache days over 12 weeks
Measured: 12 weeks
Pain scale
Reduction in the pain scale (1-10) for migraine headaches
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start2 Oct 2018
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Mar 2022 (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 Chronic MigraineStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Interventional group: 70 patients with chronic migraine who consent to OMT will receive four standardized osteopathic manipulative treatments over the course of twelve weeks. MIDAS and HIT-6 Questionnaires will be obtained at time of consent prior to first treatment and again at the conclusion of treatment period of twelve weeks. Control Group: 70 patients with the diagnosis of migraine headache will complete a MIDAS and HIT-6 questionnaire at week 0 and week 12 on standard of care for migraine treatment. A new prophylactic medication may be started at time of initial questionnaires and the patient can be on up to two prophylactic medications, with no changes during the 12 week period.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abby Rhoads, DO, Principal investigator, St. Luke's Hospital and Health Network, Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976985
- Sponsor's protocol ID
- 2018-106
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burch R, Rizzoli P, Loder E. The Prevalence and Impact of Migraine and Severe Headache in the United States: Figures and Trends From Government Health Studies. Headache. 2018 Apr;58(4):496-505. doi: 10.1111/head.13281. Epub 2018 Mar 12.
PubMed 29527677Carnes D, Mars TS, Mullinger B, Froud R, Underwood M. Adverse events and manual therapy: a systematic review. Man Ther. 2010 Aug;15(4):355-63. doi: 10.1016/j.math.2009.12.006. Epub 2010 Jan 22.
PubMed 20097115Cerritelli F, Lacorte E, Ruffini N, Vanacore N. Osteopathy for primary headache patients: a systematic review. J Pain Res. 2017 Mar 14;10:601-611. doi: 10.2147/JPR.S130501. eCollection 2017.
PubMed 28352200Voigt K, Liebnitzky J, Burmeister U, Sihvonen-Riemenschneider H, Beck M, Voigt R, Bergmann A. Efficacy of osteopathic manipulative treatment of female patients with migraine: results of a randomized controlled trial. J Altern Complement Med. 2011 Mar;17(3):225-30. doi: 10.1089/acm.2009.0673. Epub 2011 Mar 8.
PubMed 21385086McReynolds TM, Sheridan BJ. Intramuscular ketorolac versus osteopathic manipulative treatment in the management of acute neck pain in the emergency department: a randomized clinical trial. J Am Osteopath Assoc. 2005 Feb;105(2):57-68.
PubMed 15784928Zein-Hammoud M, Standley PR. Modeled Osteopathic Manipulative Treatments: A Review of Their in Vitro Effects on Fibroblast Tissue Preparations. J Am Osteopath Assoc. 2015 Aug;115(8):490-502. doi: 10.7556/jaoa.2015.103.
PubMed 26214822Francesco Cerritelli, et al. Is osteopathic manipulative treatment effective in migraine?. International Journal of Osteopathic Medicine. March 2013Volume 16, Issue 1, Pages e1-e2.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Osteopathic Manipulative Treatment on Decreasing the Severity of Migraine Headaches
- ClinicalTrials.gov ID
- NCT04976985
- Acronym / sponsor ID
- 2018-106
- Keywords
- OMT, Osteopathic Manipulative Therapy, Migraine, Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- St. Luke's Hospital, PennsylvaniaUniversity, hospital or other
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 26 Jul 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.
In this study the investigators hypothesize, that Osteopathic Manipulative Therapy (OMT) will reduce migraine disability and severity scores when compared to standard of care including prophylactic pharmacological agents with treatment over 12 week time frame. The investigators aim to decrease severity and disability of migraine by utilizing Osteopathic Manipulative Therapy. This would ultimately reduce the utilization of office or emergency department visits, decrease the large economic burden the United States faces for migraine patients as well as improve quality of life for the 3 million chronic migraine patients.
Detailed description
According to the American Headache Society, Migraine headaches affect one billion people worldwide. In the United States, one in five women and one in sixteen men suffer from migraine headaches. Migraine is the sixth most disabling illness in the world. More than four million people have chronic daily migraines with at least 15 migraines per month. More than 90% of sufferers are unable to work or function normally during their migraine attacks. Unlike many other chronic diseases, migraine affects otherwise healthy, young and middle aged people. Headache accounts for the fourth or fifth most common reason for emergency department visits and the economic burden of migraine reaches $78 billion dollars per year.
Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, non-invasive form of manual medicine. Headache has been shown to be associated with impairment of autonomic nervous system including autonomic nuclei responsible for pain perception. It has also been shown through research that persons with a migraine episode are known to release high levels of the pro-inflammatory agents, prostaglandins, dopamine and serotonin. The effect of OMT on headache can be two fold: First, by increasing parasympathetic tone, and second, by inhibiting pro-inflammatory substances. Therefore, OMT could theoretically counter balance both the release of pro-inflammatory markers as well as the autonomic nervous system leading to improved clinical outcomes. These outcomes include: decreasing patients' severity and frequency of their migraine headache, which, ultimately could improve subjects' productivity to society and decrease the economic burden of migraine sufferers.
Historically, OMT was believed to worsen migraine headaches, this study is being conducted to learn about how Osteopathic Manipulative Therapy can help migraine patients. Subjects receiving OMT could benefit from improved quality of life by reducing subject's severity and frequency of their migraine headache, which could improve their productivity to society and decrease the economic burden of migraine headaches. This could provide information to make Osteopathic Manipulative Therapy an acknowledged alternative therapy to improve quality of life for 3 million chronic migraine sufferers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional group: 70 patients with chronic migraine who consent to OMT will receive four standardized osteopathic manipulative treatments over the course of twelve weeks. MIDAS and HIT-6 Questionnaires will be obtained at time of consent prior to first treatment and again at the conclusion of treatment period of twelve weeks. Control Group: 70 patients with the diagnosis of migraine headache will complete a MIDAS and HIT-6 questionnaire at week 0 and week 12 on standard of care for migraine treatment. A new prophylactic medication may be started at time of initial questionnaires and the patient can be on up to two prophylactic medications, with no changes during the 12 week period.
| Arm | Type | Receives |
|---|---|---|
| Interventional Group receiving Osteopathic Manipulative Therapy (OMT) | Experimental | Procedure: Osteopathic Manipulative Therapy (OMT)70 patients with chronic migraine who consent to OMT will receive four standardized osteopathic manipulative treatment protocol over the course of twelve weeks at week 0,2,6,10. MIDAS and HIT-6 Questionnaires will be obtained at time of consent prior to first treatment and again at the conclusion of treatment period of twelve weeks. |
| Control Group with Standard of Care | Other | Other: Standard of care70 patients with the diagnosis of migraine headache who are receiving the standard of care medications will complete a MIDAS and HIT-6 questionnaire at week 0 and week 12. A new prophylactic medication may be started at time of initial questionnaires and the patient can be on up to two prophylactic medications, with no changes during the 12 week period. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 18-50
- Gender: Male and Female
- ICD 10 code of migraine with or without aura (G43.0, G43.1, G43.70, G43.71)
- No change in prophylactic medication for both control and intervention group
- No physical therapy for headaches, neck pain or for trapezius muscle during 12 weeks for both control and intervention group
Key exclusion criteria (8 listed)
- Previous Surgery to neck or cranium, history of previous stroke
- More than two daily prophylactic pharmacologic agents used for the indication of Migraine headache
- Active cancer
- Receiving BOTOX® for migraines or treatment within the last 4 months
- If patient has contraindications for OMT for the intervention group such as clinical signs of fractures in cervical spine, ligament instability, or severe vertebral artery stenosis
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 Therapy (OMT)Also: OMTOsteopathic Manipulative Therapy (OMT) is a non-pharmacological, noninvasive form of manual medicine. Osteopathic physicians receive special training in the musculoskeletal system to detect somatic dysfunction. Osteopathic physicians then move a patient's muscles and joints using techniques that include stretching, gentle pressure and resistance to improve muscle tonicity, treat structural abnormalities, relieve joint restriction, and decrease activation of the pain proprioception pathway. OMT Standardized Protocol A: 1. Occipital- Alanto release 2. Muscle energy and soft tissue to mid trapezius muscle 3. Muscle energy to cervical spine in all three planes of flexion/extension, rotation and side bending 4. Screening for tender points of C2-C6 at transverse and spinous processes and treatment with counterstain if tender point identified 5. Soft tissue to cervical paraspinal muscles 6. Myo-fascial release of frontal forehead 7. CV4 cranial technique | Procedure or surgery | Interventional Group receiving Osteopathic Manipulative Therapy (OMT) |
| Standard of careReceiving standard of care for migraine headaches with pharmacological medications, with no more than two prophylactic medications during the study period. Participants may also take abortive migraine medications. | Other | Control Group with Standard of Care |
Primary outcome
Reduction in the Migraine Disability Test (MIDAS) score in the OMT interventional group compared to control group.
Time frame: 12 weeks
Reduction in the Migraine Disability Test (MIDAS) score and level of disability per the MIDAS score scoring system: MIDAS Grade I (Little to no disability): 0-5 MIDAS Grade II(Mild Disability): 6-10 MIDAS Grade III (Moderate Disability): 11-20 MIDAS Grade IV (Severe Disability): 21+ minimum score: 0 maximum score: 21+ (no maximum)
Reduction in the Headache Impact Test (HIT-6) score in OMT intervention group compared to control group.
Time frame: 12 weeks
Reduction in the Headache Impact Test (HIT-6) score per the scoring system: Little or no impact: 49 or Less Some impact: 50-55 Substantial Impact: 56-59 Severe Impact: 60-78 minimum score: 36 Maximum score: 78
2 secondary outcomes
Headache Days
Time frame: 12 weeks
Pain scale
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Background: PubMed 29527677Burch R, Rizzoli P, Loder E. The Prevalence and Impact of Migraine and Severe Headache in the United States: Figures and Trends From Government Health Studies. Headache. 2018 Apr;58(4):496-505. doi: 10.1111/head.13281. Epub 2018 Mar 12.
- Background: PubMed 20097115Carnes D, Mars TS, Mullinger B, Froud R, Underwood M. Adverse events and manual therapy: a systematic review. Man Ther. 2010 Aug;15(4):355-63. doi: 10.1016/j.math.2009.12.006. Epub 2010 Jan 22.
- Background: PubMed 28352200Cerritelli F, Lacorte E, Ruffini N, Vanacore N. Osteopathy for primary headache patients: a systematic review. J Pain Res. 2017 Mar 14;10:601-611. doi: 10.2147/JPR.S130501. eCollection 2017.
- Background: PubMed 21385086Voigt K, Liebnitzky J, Burmeister U, Sihvonen-Riemenschneider H, Beck M, Voigt R, Bergmann A. Efficacy of osteopathic manipulative treatment of female patients with migraine: results of a randomized controlled trial. J Altern Complement Med. 2011 Mar;17(3):225-30. doi: 10.1089/acm.2009.0673. Epub 2011 Mar 8.
- Background: PubMed 15784928McReynolds TM, Sheridan BJ. Intramuscular ketorolac versus osteopathic manipulative treatment in the management of acute neck pain in the emergency department: a randomized clinical trial. J Am Osteopath Assoc. 2005 Feb;105(2):57-68.
- Background: PubMed 26214822Zein-Hammoud M, Standley PR. Modeled Osteopathic Manipulative Treatments: A Review of Their in Vitro Effects on Fibroblast Tissue Preparations. J Am Osteopath Assoc. 2015 Aug;115(8):490-502. doi: 10.7556/jaoa.2015.103.
- BackgroundFrancesco Cerritelli, et al. Is osteopathic manipulative treatment effective in migraine?. International Journal of Osteopathic Medicine. March 2013Volume 16, Issue 1, Pages e1-e2.
- AOA - What is Osteopathic MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chronic Migraine
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
RecruitingPhase 2
Study of EVO756 in Adults With Migraine
Migraine
Active, not recruiting
MMA Embolization for Refractory Chronic Migraine
Migraine Disorders
Active, not recruiting
Intra-Nasal Mechanical Stimulation (INMEST) as a Potential Preventative Treatment for Migraine
Migraine
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.
Abby Rhoads, DO principal investigator
St. Luke's Hospital and Health Network, Pennsylvania
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 Therapy (OMT) in people with Chronic Migraine and Migraine Disorders, run by St. Luke's Hospital, Pennsylvania 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 5 inclusion and 8 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 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the Migraine Disability Test (MIDAS) score in the OMT interventional group compared to control group. (time frame: 12 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 NCT04976985, 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 Aug 2021.