Back PainNCT05778396

Feasibility of Spinal Manual Therapy Interventions for a Future Clinical Study of Back Pain

A study testing Active spinal manual therapy protocol in people with Back Pain and Back Pain With Radiation, run by Balgrist University Hospital at 1 site in Switzerland.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Back Pain, Back Pain With Radiation, Back Pain, Low
What is being tested?: Active spinal manual therapy protocol
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 81 participants
Where: 1 siteSwitzerland
Study dates: 4 Apr 2023to 25 Apr 2023
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Aged 18 years or older
With or without experience of spinal manual therapy
With or without experience of current low back pain

Who cannot join

Serious spinal pathology (e.g. spinal fracture, cancer or infection)
History of lumbar spine surgery
Currently under care or in consultation with a specialist, chiropractor, physiotherapist, or osteopath for current back pain
Manual medicine health care provider (i.e., chiropractor, physiotherapist, osteopath, massage therapist, manual medicine trained physician)
Have a serious comorbidity preventing them from attending the research clinic and receiving the interventions
Pregnant or breastfeeding status
Involved in pending litigation related to back pain
Already participating in another research study related to back pain

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Balgrist University Hospital and CHIROMED Praxis im Seefeld
Zurich, 8008

Other trials in Switzerland

About this study

Official title: Feasibility of Blinding Spinal Manual Therapy Interventions for a Trial Assessing Management of Primary Care Patients With Back Pain: the SALuBRITY Blinding Feasibility Randomised Controlled Trial

This study aims to compare two different spinal manual therapy interventions of the back to determine if they are viable and acceptable for a future study investigating the treatment of patients with back pain. The two proposed spinal manual therapy interventions are widely used in the fields of chiropractic, physical therapy, osteopathy, and manual medicine to treat back pain and improve function. This is a randomized study, meaning that participants are randomly assigned (like tossing a coin) to one of two manual spinal therapy interventions.

Read the detailed description

Clinical trials of spinal manual therapy interventions for back pain and back-related leg pain face methodological challenges regarding the design of effective sham control ('control' hereafter) and blinding of the assigned interventions. Although the assessment of blinding is often neglected in the field of manual medicine, the implementation of high-quality trials of spinal manual therapy interventions warrants formal evaluation of blinding feasibility among participants and outcome assessors to advance randomized clinical trial methods and design.

The objectives of this blinding feasibility trial are:

To assess the feasibility of blinding participants, with or without experience of spinal manual therapy or current low back pain, randomly allocated to an active or control spinal manual therapy intervention protocol.
To assess the feasibility of blinding managing clinicians (non-treating clinicians or outcome assessors) within the randomised trial context.
To examine the impact of spinal manual therapy experience in the past 3 months (Yes vs No) and presence of low back pain during the past four weeks (average intensity ≤2 versus ≥3 out of 10) on the feasibility of participant and managing clinician blinding.
To explore factors contributing to participant and managing clinician perceptions about the assigned intervention (active versus control) using a qualitative thematic analysis.

Conditions: Back Pain, Back Pain With Radiation, Back Pain, Low
Being tested: Active spinal manual therapy protocol, Control spinal manual therapy protocol
Keywords: Methods, Manual therapy, Randomized trial, Back pain, Blinding assessment
Medical subject headings: Back Pain, Low Back Pain

What participants receive

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

Active spinal manual therapy protocolProcedure or surgery
The chiropractor will start by (1) placing one hand over L4-L5 or L5-S1 and then will apply a high-velocity, low-amplitude (HVLA) thrust with a therapeutic line of drive. Side-lying lumbar manipulation will be performed bilaterally, with the treating clinician choosing any suitable technique and with or without occurrence of the characteristic audible joint cavitation associated with spine manipulation. The chiropractor will then perform (2) prone lumbar mobilisation by placing the contact hand and applying downward pressure over L4-L5 or L5-S1 with the other hand guiding a manual flexion-distraction piece to apply therapeutic mobilization of the lumbar spine. The chiropractor will deliver (3) a prone thoracic manipulation by placing two hands over the transverse processes of T5-T6 or T6-T7 and applying a HVLA thrust in a posterior-to-anterior direction.
Control spinal manual therapy protocolProcedure or surgery
(1) Control side-lying lumbar manipulation will be operationalised as the application of a low-velocity broad push manoeuvre to the gluteal region following a non-therapeutic line of drive. The chiropractor will then perform (2) control prone lumbar mobilisation, consisting of a non-therapeutic manual manoeuvre involving minimal oscillations (0 to ±2°) of the flexion-distraction piece with light touch over the lumbar spine region, and (3) control prone thoracic mobilisation consisting of two-handed left and right scapula pushes with a nontherapeutic line of drive.

Study groups in NCT05778396
Study group	Role	What they receive
Active spinal manual therapy protocol	Active comparator	(1) Side-lying lumbar spine manipulation, (2) prone lumbar spine mobilization, and (3) prone thoracic spine manipulation. Receives: Procedure: Active spinal manual therapy protocol
Control spinal manual therapy protocol	Sham comparator	(1) Control side-lying lumbar spine manipulation, (2) control prone lumbar spine mobilization, and (3) control prone thoracic spine manipulation. Receives: Procedure: Control spinal manual therapy protocol

What is being measured

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

Participant blinding success, as measured by the validated Bang blinding index, immediately after intervention session 1.
The blinding assessment survey item will ask: "Which treatment do you believe you received?" with five response options provided: "Strongly believe I received the genuine treatment," "Somewhat believe I received the genuine treatment," "Somewhat believe I received the control treatment," "Strongly believe I received the control treatment," and "I do not know which treatment I received." Bang BI estimates (between -1 to +1, with 0 indicating satisfactory blinding) can be interpreted as the proportion of correct guesses beyond chance within an intervention arm. For the Bang BI, a score with an absolute value of ≤0.3 (i.e., -0.3 to 0.3) will be deemed compatible with satisfactory blinding, and blinding scenarios will be discussed.
Measured: Immediately after intervention session 1 (study day 1)
Participant blinding success, as measured by the validated Bang blinding index, immediately after intervention session 2.
The blinding assessment survey item will ask: "Which treatment do you believe you received?" with five response options provided: "Strongly believe I received the genuine treatment," "Somewhat believe I received the genuine treatment," "Somewhat believe I received the control treatment," "Strongly believe I received the control treatment," and "I do not know which treatment I received." Bang BI estimates (between -1 to +1, with 0 indicating satisfactory blinding) can be interpreted as the proportion of correct guesses beyond chance within an intervention arm. For the Bang BI, a score with an absolute value of ≤0.3 (i.e., -0.3 to 0.3) will be deemed compatible with satisfactory blinding, and blinding scenarios will be discussed.
Measured: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)

Secondary outcomes (6)

Participant blinding success, as measured by the validated James blinding index, immediately after intervention session 1.
The James BI, a modification of the kappa statistic that measures disagreement beyond chance, returns a value between 0 and 1, with 1 equal to all "don't know" responses (complete blinding), 0 equal to all correct responses (complete unblinding), and 0.5 where respondents' responses appear random (50% correct, 50% incorrect).
Measured: Immediately after intervention session 1 (study day 1)
Participant blinding success, as measured by the validated James blinding index, immediately after intervention session 2.
The James BI, a modification of the kappa statistic that measures disagreement beyond chance, returns a value between 0 and 1, with 1 equal to all "don't know" responses (complete blinding), 0 equal to all correct responses (complete unblinding), and 0.5 where respondents' responses appear random (50% correct, 50% incorrect).
Measured: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
Outcome assessor blinding success, as measured by the validated Bang index, immediately after intervention session 1.
Bang BI estimates (between -1 to +1, with 0 indicating satisfactory blinding) can be interpreted as the proportion of correct guesses beyond chance within an intervention arm.
Measured: Immediately after intervention session 1 (study day 1)
Outcome assessor blinding success, as measured by the validated Bang index, immediately after intervention session 2.
Bang BI estimates (between -1 to +1, with 0 indicating satisfactory blinding) can be interpreted as the proportion of correct guesses beyond chance within an intervention arm.
Measured: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
Outcome assessor blinding success, as measured by the validated James index, immediately after intervention session 1.
The James BI measures disagreement beyond chance and returns a value between 0 and 1, with 1 equal to all "don't know" responses (complete blinding), 0 equal to all correct responses (complete unblinding), and 0.5 where respondents' responses appear random (50% correct, 50% incorrect).
Measured: Immediately after intervention session 1 (study day 1)
Outcome assessor blinding success, as measured by the validated James index, immediately after intervention session 2.
The James BI measures disagreement beyond chance and returns a value between 0 and 1, with 1 equal to all "don't know" responses (complete blinding), 0 equal to all correct responses (complete unblinding), and 0.5 where respondents' responses appear random (50% correct, 50% incorrect).
Measured: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)

Timeline

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

4 Apr 202325 Apr 2023

First posted21 Mar 2023
Study start4 Apr 2023
Primary completion25 Apr 2023
Study completion25 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Two-parallel-group, single-centre, sham-controlled, methodological blinding feasibility randomised trial.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05778396
Sponsor's protocol ID: SALuBRITY Blinding
Status last verified: Jun 2023
First submitted: 27 Feb 2023
Last updated: 2 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The central contact person and principal investigator will make supporting information available upon reasonable request.

Publications

Munoz Laguna J, Kurmann A, Hofstetter L, Nyantakyi E, Braun J, Clack L, Bang H, Farshad M, Foster NE, Puhan MA, Hincapie CA; SALuBRITY Blinding Clinician Group. 'Which treatment do you believe you received?' A randomised blinding feasibility trial of spinal manual therapy. Chiropr Man Therap. 2025 Jan 14;33(1):4. doi: 10.1186/s12998-024-00561-0.
PubMed 39810207
Munoz Laguna J, Kurmann A, Hofstetter L, Nyantakyi E, Clack L, Bang H, Foster NE, Braun J, Puhan MA, Farshad M, Hincapie CA. Feasibility of blinding spinal manual therapy interventions among participants and outcome assessors: protocol for a blinding feasibility trial. Pilot Feasibility Stud. 2024 May 2;10(1):70. doi: 10.1186/s40814-024-01492-6.
PubMed 38698433

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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ESP Blocks for Posterior Spinal Fusion
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain

All Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility of Blinding Spinal Manual Therapy Interventions for a Trial Assessing Management of Primary Care Patients With Back Pain: the SALuBRITY Blinding Feasibility Randomised Controlled Trial
ClinicalTrials.gov ID: NCT05778396
Acronym / sponsor ID: SALuBRITY Blinding
Conditions: Back Pain, Back Pain With Radiation, Back Pain, Low
Keywords: Methods, Manual therapy, Randomized trial, Back pain, Blinding assessment
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Balgrist University HospitalUniversity, hospital or other
Collaborators: University of Zurich
Study start: 4 Apr 2023 (actual)
Primary completion: 25 Apr 2023 (actual)
Study completion: 25 Apr 2023 (actual)
First posted: 21 Mar 2023 (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.

Detailed description

The objectives of this blinding feasibility trial are:

To assess the feasibility of blinding participants, with or without experience of spinal manual therapy or current low back pain, randomly allocated to an active or control spinal manual therapy intervention protocol.
To assess the feasibility of blinding managing clinicians (non-treating clinicians or outcome assessors) within the randomised trial context.
To examine the impact of spinal manual therapy experience in the past 3 months (Yes vs No) and presence of low back pain during the past four weeks (average intensity ≤2 versus ≥3 out of 10) on the feasibility of participant and managing clinician blinding.
To explore factors contributing to participant and managing clinician perceptions about the assigned intervention (active versus control) using a qualitative thematic analysis.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Two-parallel-group, single-centre, sham-controlled, methodological blinding feasibility randomised trial.

Arm	Type	Receives
Active spinal manual therapy protocol	Active comparator	Procedure: Active spinal manual therapy protocol(1) Side-lying lumbar spine manipulation, (2) prone lumbar spine mobilization, and (3) prone thoracic spine manipulation.
Control spinal manual therapy protocol	Sham comparator	Procedure: Control spinal manual therapy protocol(1) Control side-lying lumbar spine manipulation, (2) control prone lumbar spine mobilization, and (3) control prone thoracic spine manipulation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Aged 18 years or older
With or without experience of spinal manual therapy
With or without experience of current low back pain

Key exclusion criteria (8 listed)

Serious spinal pathology (e.g. spinal fracture, cancer or infection)
History of lumbar spine surgery
Currently under care or in consultation with a specialist, chiropractor, physiotherapist, or osteopath for current back pain
Manual medicine health care provider (i.e., chiropractor, physiotherapist, osteopath, massage therapist, manual medicine trained physician)
Have a serious comorbidity preventing them from attending the research clinic and receiving the interventions

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
Active spinal manual therapy protocolThe chiropractor will start by (1) placing one hand over L4-L5 or L5-S1 and then will apply a high-velocity, low-amplitude (HVLA) thrust with a therapeutic line of drive. Side-lying lumbar manipulation will be performed bilaterally, with the treating clinician choosing any suitable technique and with or without occurrence of the characteristic audible joint cavitation associated with spine manipulation. The chiropractor will then perform (2) prone lumbar mobilisation by placing the contact hand and applying downward pressure over L4-L5 or L5-S1 with the other hand guiding a manual flexion-distraction piece to apply therapeutic mobilization of the lumbar spine. The chiropractor will deliver (3) a prone thoracic manipulation by placing two hands over the transverse processes of T5-T6 or T6-T7 and applying a HVLA thrust in a posterior-to-anterior direction.	Procedure or surgery	Active spinal manual therapy protocol
Control spinal manual therapy protocol(1) Control side-lying lumbar manipulation will be operationalised as the application of a low-velocity broad push manoeuvre to the gluteal region following a non-therapeutic line of drive. The chiropractor will then perform (2) control prone lumbar mobilisation, consisting of a non-therapeutic manual manoeuvre involving minimal oscillations (0 to ±2°) of the flexion-distraction piece with light touch over the lumbar spine region, and (3) control prone thoracic mobilisation consisting of two-handed left and right scapula pushes with a nontherapeutic line of drive.	Procedure or surgery	Control spinal manual therapy protocol

Primary outcome

Participant blinding success, as measured by the validated Bang blinding index, immediately after intervention session 1.
Time frame: Immediately after intervention session 1 (study day 1)
The blinding assessment survey item will ask: "Which treatment do you believe you received?" with five response options provided: "Strongly believe I received the genuine treatment," "Somewhat believe I received the genuine treatment," "Somewhat believe I received the control treatment," "Strongly believe I received the control treatment," and "I do not know which treatment I received." Bang BI estimates (between -1 to +1, with 0 indicating satisfactory blinding) can be interpreted as the proportion of correct guesses beyond chance within an intervention arm. For the Bang BI, a score with an absolute value of ≤0.3 (i.e., -0.3 to 0.3) will be deemed compatible with satisfactory blinding, and blinding scenarios will be discussed.
Participant blinding success, as measured by the validated Bang blinding index, immediately after intervention session 2.
Time frame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
The blinding assessment survey item will ask: "Which treatment do you believe you received?" with five response options provided: "Strongly believe I received the genuine treatment," "Somewhat believe I received the genuine treatment," "Somewhat believe I received the control treatment," "Strongly believe I received the control treatment," and "I do not know which treatment I received." Bang BI estimates (between -1 to +1, with 0 indicating satisfactory blinding) can be interpreted as the proportion of correct guesses beyond chance within an intervention arm. For the Bang BI, a score with an absolute value of ≤0.3 (i.e., -0.3 to 0.3) will be deemed compatible with satisfactory blinding, and blinding scenarios will be discussed.

6 secondary outcomes

Participant blinding success, as measured by the validated James blinding index, immediately after intervention session 1.
Time frame: Immediately after intervention session 1 (study day 1)
Participant blinding success, as measured by the validated James blinding index, immediately after intervention session 2.
Time frame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
Outcome assessor blinding success, as measured by the validated Bang index, immediately after intervention session 1.
Time frame: Immediately after intervention session 1 (study day 1)
Outcome assessor blinding success, as measured by the validated Bang index, immediately after intervention session 2.
Time frame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)
Outcome assessor blinding success, as measured by the validated James index, immediately after intervention session 1.
Time frame: Immediately after intervention session 1 (study day 1)
Outcome assessor blinding success, as measured by the validated James index, immediately after intervention session 2.
Time frame: Immediately after intervention session 2 (study day 2, between 48 hours and 2 weeks after study day 1)

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 2 Jun 2023.
Derived from this study: PubMed 39810207Munoz Laguna J, Kurmann A, Hofstetter L, Nyantakyi E, Braun J, Clack L, Bang H, Farshad M, Foster NE, Puhan MA, Hincapie CA; SALuBRITY Blinding Clinician Group. 'Which treatment do you believe you received?' A randomised blinding feasibility trial of spinal manual therapy. Chiropr Man Therap. 2025 Jan 14;33(1):4. doi: 10.1186/s12998-024-00561-0.
Derived from this study: PubMed 38698433Munoz Laguna J, Kurmann A, Hofstetter L, Nyantakyi E, Clack L, Bang H, Foster NE, Braun J, Puhan MA, Farshad M, Hincapie CA. Feasibility of blinding spinal manual therapy interventions among participants and outcome assessors: protocol for a blinding feasibility trial. Pilot Feasibility Stud. 2024 May 2;10(1):70. doi: 10.1186/s40814-024-01492-6.
Individual participant dataSharing planned: Yes. The central contact person and principal investigator will make supporting information available upon reasonable request.

Related trials for Back Pain

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain

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.

Cesar A Hincapié, DC PhD principal investigator

Balgrist University Hospital and University of Zurich

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

Questions about this trial

What is this clinical trial studying?

A study testing Active spinal manual therapy protocol in people with Back Pain and Back Pain With Radiation, run by Balgrist University Hospital at 1 site in Switzerland.

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 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: finished, as of the sponsor's last update on 2 Jun 2023. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?

Participant blinding success, as measured by the validated Bang blinding index, immediately after intervention session 1. (time frame: Immediately after intervention session 1 (study day 1)). 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 NCT05778396, which also lists 2 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 2 Jun 2023.