Acute Low-back PainNCT04494698

Impact of DuoTherm Compared to TENS on Pain and Disability With Acute and Chronic Low Back Pain

A study testing Duotherm VibraCool Back Device and TENS 8-channel unit in people with Acute Low-back Pain and Chronic Low-back Pain, run by MMJ Labs LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Evaluate pain and disability change in Low Back Pain with DuoTherm Compared to Active Control Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Acute Low-back Pain, Chronic Low-back Pain, Pain, Intractable
What is being tested?: Duotherm VibraCool Back Device and TENS 8-channel unit
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 2 sitesUnited States
Study dates: 23 Jun 2022to 24 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 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Pacemaker
Radicular pain likely reflecting a surgical or mechanical problem
BMI greater than 50 (device won't fit, initially thought to be BMI 30 but up to 50 included)
Sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease)
Diabetic neuropathy rendering a patient unable to determine if the device is too hot
New neurologic deficits

Show all 9Show fewer

Skin lesions over the low back area
Contraindication to any medication for pain management that would impact analgesic use record
Inability to apply DuoTherm or Active Control TENS Device

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Sport and Spine Rehab Clinic
Fairfax, Virginia, 22030
Sport and Spine Rehab Clinics
Landover, Maryland, 20785

Other trials in United States

About this study

Official title: Addressing Pain and Disability From Low Back Pain With an External Multimodal Neuromodulation Device

Evaluate pain and disability change in Low Back Pain with DuoTherm Compared to Active Control

Read the detailed description

160 patients with moderate to severe acute or exacerbations of chronic low back pain presenting for chiropractic and rehabilitation care will be randomized to one of two conditions: a pain relief belt device incorporating multiple speeds of vibration and optional heat, cold, and pressure delivered through a sculpted metal plate; or an 8 channel prescription TENS unit. Patients will be prompted by a Qualtrics text link to a secure data recording site collecting pain and medication use.

Conditions: Acute Low-back Pain, Chronic Low-back Pain, Pain, Intractable
Being tested: Duotherm VibraCool Back Device, TENS 8-channel unit
Keywords: chronic low back pain, spine pain, medical device, analgesia, vibration, Multifidus
Medical subject headings: Pain, Intractable, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Duotherm VibraCool Back DeviceDevice
Also called Vibracool plus heat or pressure, Buzzy
Active New multimodal pain device
TENS 8-channel unitDevice
LG Smart TENS unit

Study groups in NCT04494698
Study group	Role	What they receive
DuoTherm VibraCool Back Device	Experimental	A multimodal low back pain relief device incorporating 8 mechanical stimulation patterns of vibration and 5 intensity settings with optional heat, cold, or pressure delivered through a sculpted metal plate attached by a belt and controlled by buttons on the belt. Patients will be instructed to use the device daily for 30 minutes. Receives: Device: Duotherm VibraCool Back Device
Multimodal TENS Unit	Active comparator	LG SMART TENS stimulator is an 8-channel portable electrotherapy device featuring transcutaneous electrical nerve stimulation (TENS) therapeutic device, which is used for pain relief. The stimulator sends a gentle electrical current to underlying nerves and muscle groups via electrodes applied on the skin. The parameters of the device are controlled by buttons on a controller with an adjustable intensity level. Receives: Device: TENS 8-channel unit

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in current pain intensity from initial to final
Self-rated current pain on Numeric Rating Scale with 0 no pain and 10 maximum pain
Measured: Daily for 30 days, then weekly and monthly until 3 months (acute) or 6 months (chronic)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Response formats for all scales are a 5-point ordinal rating scale of "Not at all," "A little bit," "Somewhat," "Quite a bit," and "Very much," where lower scores are better and higher scores indicate worse pain. The outcomes being addressed are Change in Monthly Pain Interference (8 questions, yielding possible scores of 8 (low) to 40 (highest) normed on a T-Score where 50 is the average in the United States, 40.7 is "no disability", 55 is mild, 57.7 is moderate, and 65.7 is severe
Measured: Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic)

Secondary outcomes (2)

Resolution of disability using PROMIS Pain Interference
Achievement of average pain interference of a T-Score of 50 at last recorded PROMIS Pain Interference
Measured: Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (8a) measures in those with intractable pain as defined and compared with surgical multifidus intervention studies
Comparison between the experimental and active control interventions crosswalked with the Oswestry Disability outcomes in multifudus electrical stimulation studies.
Measured: Initial through 6 month measurements (or 13 week if chronic enrolled as acute)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jun 202224 Jun 2025

First posted31 Jul 2020
Study start23 Jun 2022
Primary completion9 Jul 2024
Study completion24 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Acute Low-back PainStudies 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: Randomised
Intervention model: Parallel groups
Model description: Randomized active control
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04494698
Sponsor's protocol ID: DuoTherm for Low Back Pain
Other IDs: 4R44DA049631
Status last verified: Jul 2025
First submitted: 28 Jul 2020
Last updated: 18 Jul 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Individual participant data that underlie the clinical results reported in any publications, after deidentification, will be available for a period of 36 months after publication to achieve approved aims of any researcher who provides a methodologically sound proposal. Proposals should be directed to info@mmjlabs.com. To gain acccess, data requestors will need to sign a data access agreement.

Publications

Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, Delitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. Phys Ther. 2015 Feb;95(2):e1-e18. doi: 10.2522/ptj.2015.95.2.e1.
PubMed 25639530
Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
PubMed 11690728
Stumbo SP, Yarborough BJ, McCarty D, Weisner C, Green CA. Patient-reported pathways to opioid use disorders and pain-related barriers to treatment engagement. J Subst Abuse Treat. 2017 Feb;73:47-54. doi: 10.1016/j.jsat.2016.11.003. Epub 2016 Nov 15.
PubMed 28017184
Darnall BD, Colloca L. Optimizing Placebo and Minimizing Nocebo to Reduce Pain, Catastrophizing, and Opioid Use: A Review of the Science and an Evidence-Informed Clinical Toolkit. Int Rev Neurobiol. 2018;139:129-157. doi: 10.1016/bs.irn.2018.07.022. Epub 2018 Aug 6.
PubMed 30146045
Furlan AD, Giraldo M, Baskwill A, Irvin E, Imamura M. Massage for low-back pain. Cochrane Database Syst Rev. 2015 Sep 1;2015(9):CD001929. doi: 10.1002/14651858.CD001929.pub3.
PubMed 26329399
Maddalozzo GF, Kuo B, Maddalozzo WA, Maddalozzo CD, Galver JW. Comparison of 2 Multimodal Interventions With and Without Whole Body Vibration Therapy Plus Traction on Pain and Disability in Patients With Nonspecific Chronic Low Back Pain. J Chiropr Med. 2016 Dec;15(4):243-251. doi: 10.1016/j.jcm.2016.07.001. Epub 2016 Aug 25.
PubMed 27857632
Cohen SP, Bhaskar A, Bhatia A, Buvanendran A, Deer T, Garg S, Hooten WM, Hurley RW, Kennedy DJ, McLean BC, Moon JY, Narouze S, Pangarkar S, Provenzano DA, Rauck R, Sitzman BT, Smuck M, van Zundert J, Vorenkamp K, Wallace MS, Zhao Z. Consensus practice guidelines on interventions for lumbar facet joint pain from a multispecialty, international working group. Reg Anesth Pain Med. 2020 Jun;45(6):424-467. doi: 10.1136/rapm-2019-101243. Epub 2020 Apr 3.
PubMed 32245841
Tang X, Schalet BD, Hung M, Brodke DS, Saltzman CL, Cella D. Linking Oswestry Disability Index to the PROMIS pain interference CAT with equipercentile methods. Spine J. 2021 Jul;21(7):1185-1192. doi: 10.1016/j.spinee.2021.02.012. Epub 2021 Feb 19.
PubMed 33610807
Gilligan C, Volschenk W, Russo M, Green M, Gilmore C, Mehta V, Deckers K, De Smedt K, Latif U, Sayed D, Georgius P, Gentile J, Mitchell B, Langhorst M, Huygen F, Baranidharan G, Patel V, Mironer E, Ross E, Carayannopoulos A, Hayek S, Gulve A, Van Buyten JP, Tohmeh A, Fischgrund J, Lad S, Ahadian F, Deer T, Klemme W, Rauck R, Rathmell J, Maislin G, Heemels JP, Eldabe S. Five-Year Longitudinal Follow-Up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction. Neuromodulation. 2024 Jul;27(5):930-943. doi: 10.1016/j.neurom.2024.01.006. Epub 2024 Mar 12.
PubMed 38483366
Baxter AL, Thrasher A, Etnoyer-Slaski JL, Cohen LL. Multimodal mechanical stimulation reduces acute and chronic low back pain: Pilot data from a HEAL phase 1 study. Front Pain Res (Lausanne). 2023 Apr 26;4:1114633. doi: 10.3389/fpain.2023.1114633. eCollection 2023.
PubMed 37179530
Baxter AL, Etnoyer-Slaski JL, Tucker O, Williams JAR, Swartout K, Cohen LL, Lawson ML. Novel multimodal mechanical stimulation is superior to TENS to treat and prevent chronic low back pain: a randomized controlled trial. Front Pain Res (Lausanne). 2025 Aug 18;6:1625420. doi: 10.3389/fpain.2025.1625420. eCollection 2025.
PubMed 40901560

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Low-back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Addressing Pain and Disability From Low Back Pain With an External Multimodal Neuromodulation Device
ClinicalTrials.gov ID: NCT04494698
Acronym / sponsor ID: DuoTherm for Low Back Pain
Conditions: Acute Low-back Pain, Chronic Low-back Pain, Pain, Intractable
Keywords: chronic low back pain, spine pain, medical device, analgesia, vibration, Multifidus
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: MMJ Labs LLCIndustry (pharma, biotech, devices)
Collaborators: Sport and Spine Rehab Clinical Research Foundation, National Institute on Drug Abuse (NIDA)
Study start: 23 Jun 2022 (actual)
Primary completion: 9 Jul 2024 (actual)
Study completion: 24 Jun 2025 (actual)
First posted: 31 Jul 2020 (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.

Evaluate pain and disability change in Low Back Pain with DuoTherm Compared to Active Control

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized active control

Arm	Type	Receives
DuoTherm VibraCool Back Device	Experimental	Device: Duotherm VibraCool Back DeviceA multimodal low back pain relief device incorporating 8 mechanical stimulation patterns of vibration and 5 intensity settings with optional heat, cold, or pressure delivered through a sculpted metal plate attached by a belt and controlled by buttons on the belt. Patients will be instructed to use the device daily for 30 minutes.
Multimodal TENS Unit	Active comparator	Device: TENS 8-channel unitLG SMART TENS stimulator is an 8-channel portable electrotherapy device featuring transcutaneous electrical nerve stimulation (TENS) therapeutic device, which is used for pain relief. The stimulator sends a gentle electrical current to underlying nerves and muscle groups via electrodes applied on the skin. The parameters of the device are controlled by buttons on a controller with an adjustable intensity level.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (9 listed)

Pacemaker
Radicular pain likely reflecting a surgical or mechanical problem
BMI greater than 50 (device won't fit, initially thought to be BMI 30 but up to 50 included)
Sensitivity to cold or vibration (e.g Raynaud's or Sickle Cell Disease)
Diabetic neuropathy rendering a patient unable to determine if the device is too hot

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
Duotherm VibraCool Back DeviceAlso: Vibracool plus heat or pressure, BuzzyActive New multimodal pain device	Device	DuoTherm VibraCool Back Device
TENS 8-channel unitLG Smart TENS unit	Device	Multimodal TENS Unit

Primary outcome

Change in current pain intensity from initial to final
Time frame: Daily for 30 days, then weekly and monthly until 3 months (acute) or 6 months (chronic)
Self-rated current pain on Numeric Rating Scale with 0 no pain and 10 maximum pain
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Time frame: Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic)
Response formats for all scales are a 5-point ordinal rating scale of "Not at all," "A little bit," "Somewhat," "Quite a bit," and "Very much," where lower scores are better and higher scores indicate worse pain. The outcomes being addressed are Change in Monthly Pain Interference (8 questions, yielding possible scores of 8 (low) to 40 (highest) normed on a T-Score where 50 is the average in the United States, 40.7 is "no disability", 55 is mild, 57.7 is moderate, and 65.7 is severe

2 secondary outcomes

Resolution of disability using PROMIS Pain Interference
Time frame: Baseline then weekly and monthly until 3 months (acute) or 6 months (chronic)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (8a) measures in those with intractable pain as defined and compared with surgical multifidus intervention studies
Time frame: Initial through 6 month measurements (or 13 week if chronic enrolled as acute)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
Background: PubMed 25639530Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, Delitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on research standards for chronic low back pain. Phys Ther. 2015 Feb;95(2):e1-e18. doi: 10.2522/ptj.2015.95.2.e1.
Background: PubMed 11690728Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
Background: PubMed 28017184Stumbo SP, Yarborough BJ, McCarty D, Weisner C, Green CA. Patient-reported pathways to opioid use disorders and pain-related barriers to treatment engagement. J Subst Abuse Treat. 2017 Feb;73:47-54. doi: 10.1016/j.jsat.2016.11.003. Epub 2016 Nov 15.
Background: PubMed 30146045Darnall BD, Colloca L. Optimizing Placebo and Minimizing Nocebo to Reduce Pain, Catastrophizing, and Opioid Use: A Review of the Science and an Evidence-Informed Clinical Toolkit. Int Rev Neurobiol. 2018;139:129-157. doi: 10.1016/bs.irn.2018.07.022. Epub 2018 Aug 6.
Background: PubMed 26329399Furlan AD, Giraldo M, Baskwill A, Irvin E, Imamura M. Massage for low-back pain. Cochrane Database Syst Rev. 2015 Sep 1;2015(9):CD001929. doi: 10.1002/14651858.CD001929.pub3.
Background: PubMed 27857632Maddalozzo GF, Kuo B, Maddalozzo WA, Maddalozzo CD, Galver JW. Comparison of 2 Multimodal Interventions With and Without Whole Body Vibration Therapy Plus Traction on Pain and Disability in Patients With Nonspecific Chronic Low Back Pain. J Chiropr Med. 2016 Dec;15(4):243-251. doi: 10.1016/j.jcm.2016.07.001. Epub 2016 Aug 25.
Background: PubMed 32245841Cohen SP, Bhaskar A, Bhatia A, Buvanendran A, Deer T, Garg S, Hooten WM, Hurley RW, Kennedy DJ, McLean BC, Moon JY, Narouze S, Pangarkar S, Provenzano DA, Rauck R, Sitzman BT, Smuck M, van Zundert J, Vorenkamp K, Wallace MS, Zhao Z. Consensus practice guidelines on interventions for lumbar facet joint pain from a multispecialty, international working group. Reg Anesth Pain Med. 2020 Jun;45(6):424-467. doi: 10.1136/rapm-2019-101243. Epub 2020 Apr 3.
Background: PubMed 33610807Tang X, Schalet BD, Hung M, Brodke DS, Saltzman CL, Cella D. Linking Oswestry Disability Index to the PROMIS pain interference CAT with equipercentile methods. Spine J. 2021 Jul;21(7):1185-1192. doi: 10.1016/j.spinee.2021.02.012. Epub 2021 Feb 19.
Background: PubMed 38483366Gilligan C, Volschenk W, Russo M, Green M, Gilmore C, Mehta V, Deckers K, De Smedt K, Latif U, Sayed D, Georgius P, Gentile J, Mitchell B, Langhorst M, Huygen F, Baranidharan G, Patel V, Mironer E, Ross E, Carayannopoulos A, Hayek S, Gulve A, Van Buyten JP, Tohmeh A, Fischgrund J, Lad S, Ahadian F, Deer T, Klemme W, Rauck R, Rathmell J, Maislin G, Heemels JP, Eldabe S. Five-Year Longitudinal Follow-Up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction. Neuromodulation. 2024 Jul;27(5):930-943. doi: 10.1016/j.neurom.2024.01.006. Epub 2024 Mar 12.
Background: PubMed 37179530Baxter AL, Thrasher A, Etnoyer-Slaski JL, Cohen LL. Multimodal mechanical stimulation reduces acute and chronic low back pain: Pilot data from a HEAL phase 1 study. Front Pain Res (Lausanne). 2023 Apr 26;4:1114633. doi: 10.3389/fpain.2023.1114633. eCollection 2023.
Derived from this study: PubMed 40901560Baxter AL, Etnoyer-Slaski JL, Tucker O, Williams JAR, Swartout K, Cohen LL, Lawson ML. Novel multimodal mechanical stimulation is superior to TENS to treat and prevent chronic low back pain: a randomized controlled trial. Front Pain Res (Lausanne). 2025 Aug 18;6:1625420. doi: 10.3389/fpain.2025.1625420. eCollection 2025.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the clinical results reported in any publications, after deidentification, will be available for a period of 36 months after publication to achieve approved aims of any researcher who provides a methodologically sound proposal. Proposals should be directed to info@mmjlabs.com. To gain acccess, data requestors will need to sign a data access agreement.

Related trials for Acute Low-back Pain

Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)
Not yet recruiting
Evaluation of a Program to Prevent Recurrences of Episodes of Acute Low Back Pain, Assisted by the Axomove Application
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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.

Amy Baxter, MD principal investigator

Pain Care Labs (a dba of MMJ Labs)

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Duotherm VibraCool Back Device and TENS 8-channel unit in people with Acute Low-back Pain and Chronic Low-back Pain, run by MMJ Labs LLC at 2 sites 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 0 inclusion and 9 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 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in current pain intensity from initial to final (time frame: Daily for 30 days, then weekly and monthly until 3 months (acute) or 6 months (chronic)). 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 NCT04494698, which also lists 11 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 18 Jul 2025.