Post-mastectomy Pain SyndromePhase 2NCT04267315
Trigger Point Injections for Post-Mastectomy Pain Syndrome
A Phase 2 study testing Trigger point injection, Subcutaneous saline injection and Comprehensive Rehabilitation program in people with Post-mastectomy Pain Syndrome and Myofascial Pain Syndrome, run by Instituto do Cancer do Estado de São Paulo at 2 sites in Brazil.
Trial summary
Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain that persists for more than three months after a surgical breast procedure. It has 11-70% incidence in patients that underwent a breast surgery. It consists of mixed pain, frequently associated with myofascial pain, an specific type of muscular pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post-mastectomy Pain Syndrome, Myofascial Pain Syndrome, Trigger Point Pain, Myofascial
- What is being tested?
- Trigger point injection, Subcutaneous saline injection and Comprehensive Rehabilitation program
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesBrazil
- Study dates
- 3 Jan 2020to 15 Feb 2024
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Breast cancer patients.
- PMPS diagnosis, as per Wisotzky et col.
- Pain > 3 months over breast, chest wall or shoulder ipsilateral to surgery.
- Pain Visual analog Scale (VAS) ≥4.
- At least one active trigger point in the following muscles: pectoralis major, superior trapezius, serratus anterior, levator scapularis, latissimus dorsi, infraspinatus
Who cannot join
- Current radiation therapy or time since completion < 3months.
- Allergy to lidocaine or other local anesthetics
- Active infection over injection sites
- Unavailability to be at the hospital during study intervention.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital de Câncer de Barretos
Barretos, São Paulo
Instituto do Câncer do Estado de São Paulo
São Paulo
About this study
Official title: Trigger Point Injections for Post-Mastectomy Pain Syndrome: A Double-Blind Randomized Controlled Trial With Intention-to-Treat Analysis
Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain that persists for more than three months after a surgical breast procedure. It has 11-70% incidence in patients that underwent a breast surgery. It consists of mixed pain, frequently associated with myofascial pain, an specific type of muscular pain. Trigger point injections (TPI) are classically used for the treatment of myofascial pain in other painful conditions. However, there are no controlled trials assessing the efficacy of TPI in the treatment of PMPS. The intervention objective is to assess the efficacy of TPI in patients with PMPS, when associated with a comprehensive rehabilitation program and pain management.
Read the detailed description
INTRODUCTION: Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain that persists for more than three months after a surgical breast procedure. It has 11-70% incidence in patients that underwent a breast surgery. It consists of mixed pain, frequently associated with myofascial pain. Trigger point injections (TPI) are classically used for the treatment of myofascial pain in other etiologies. However, there are no controlled trials assessing the efficacy of TPI in the treatment of PMPS
OBJECTIVE: Assess the efficacy of TPI in patients with PMPS, when associated with a comprehensive rehabilitation program and pain management.
METHODS: Double-blind randomized controlled trial with intention-to-treat analysis. Both groups will undergo standard of care delivered by Physiatrist blinded to group allocation. Active group will undergo TPI with 1% lidocaine in each identified trigger-point, weekly, for three consecutive weeks. Control group will undergo subcutaneous saline injection superficial to the same trigger points, with the same frequency and number of sessions. Primary outcome is the mean difference between groups for pain levels, as assessed by Visual Numeric Scale (VNS), from baseline to 3 months after the procedure.
STATISTICAL ANALYSIS: Difference between groups at baseline, one and three months after injection, using Analysis of Covariance (ANCOVA) for the following outcomes: VNS; Presence of active trigger points, Pressure pain threshold (PPT); Short-Form McGill Pain Questionnaire (SF-MPQ); Neuropathic Pain Symptom Inventory (NPSI); Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH); Range of motion (ROM) of affected shoulder, for abduction and external rotation; adverse events; use of pain medication.
Total sample size is 120. Alpha=5%, power=80%.
- Conditions
- Post-mastectomy Pain Syndrome, Myofascial Pain Syndrome, Trigger Point Pain, Myofascial, Breast Cancer
- Being tested
- Trigger point injection, Subcutaneous saline injection, Comprehensive Rehabilitation program
- Medical subject headings
- Myofascial Pain Syndromes, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigger point injectionProcedure or surgery
1mL injections of 1% lidocaine in the muscles identified active trigger points at the day of intervention (pectoralis major, serratus anterior, levator scapulae, latissimus dorsi, infraspinatus).
Subcutaneous saline injectionProcedure or surgery
0.2mL subcutaneous saline injections superficial to the muscles identified with active trigger points at the day of intervention (pectoralis major, serratus anterior, levator scapulae, latissimus dorsi, infraspinatus).
Comprehensive Rehabilitation programOther
Patients in both groups will undergo standard of care rehabilitation delivered by a Physiatrist, which may include Physical Therapy, Occupational Therapy, Exercise Physiologist, Rehabilitation Nurse, Psychologist, as per Physiatrist's prescription. Both the comprehensive rehabilitation program and pain medications will continue to be managed by participant's Physiatrist, who will be blinded to patient's allocation. The researchers will be responsible for TPI and for data collection.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | 3 weekly sessions of TPI. Participants will undergo 1mL injections of 1% lidocaine in the muscles identified with either active or latent trigger points at the initial assessment. The same muscles will be injected at all procedures. Receives: Procedure: Trigger point injection; Other: Comprehensive Rehabilitation program |
| Placebo | Sham comparator | 3 weekly sessions of subcutaneous saline injections. Participants will undergo 0.2mL subcutaneous saline injections superficial to the trigger points identified at initial assessment. The same superficial sites will be injected in all procedures. Receives: Procedure: Subcutaneous saline injection; Other: Comprehensive Rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Numeric Scale (VNS) for pain in 3 months
Mean difference of Pain between groups from baseline to 3 months(T3m), assessed by the Visual Numeric Scale (VNS, 0-10), in which higher scores represent higher pain intensity.
Measured: 3 months
Trigger-points
Number of active trigger-points in the assessed muscles (latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior). Mean difference between groups.
Measured: 1 month
Trigger-points
Number of active trigger-points in the assessed muscles (latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior). Mean difference between groups.
Measured: 3 months
Pressure Pain Threshold (PPT)
Pressure Pain Threshold (PPT) at bilateral latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior. Difference from baseline
Measured: 1 month
Pressure Pain Threshold
Pressure Pain Threshold (PPT) at bilateral latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior. Difference from baseline
Measured: 3 months
Secondary outcomes (17)
Visual Numeric Scale (VNS) for pain in 1 month
Mean difference of Pain between groups from baseline,assessed by the Visual Numeric Scale (VNS, 0-10), in which higher scores represent higher pain intensity.
Measured: 1 month
Short-Form McGill Pain Questionnaire (SF-MPQ) - total score, sensorial and affective scale
Short-Form McGill Pain Questionnaire - total score, sensorial and affective scale. Mean difference between groups from baseline. Higher values represent higher pain intensity
Measured: 1 month
Short-Form McGill Pain Questionnaire (SF-MPQ) - total score, sensorial and affective scale
Short-Form McGill Pain Questionnaire - total score, sensorial and affective scale. Mean difference between groups from baseline. Higher values represent higher pain intensity
Measured: 3 months
Neuropathic Pain Symptom Inventory (NPSI)
Neuropathic Pain Symptom Inventory . Mean difference between groups from baseline. Higher values represent more symptoms of neuropathic pain.
Measured: 1 month.
Neuropathic Pain Symptom Inventory (NPSI)
Neuropathic Pain Symptom Inventory . Mean difference between groups from baseline. Higher values represent more symptoms of neuropathic pain.
Measured: 3 months
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH). Mean difference between groups from baseline. Higher values represent lower functionality.
Measured: 1 month
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH). Mean difference between groups from baseline. Higher values represent lower functionality.
Measured: 3 months
Shoulder range of motion (ROM)
Range of motion (ROM) of affected shoulder, for abduction and external rotation. Mean difference between groups from baseline.
Measured: 1 month
Shoulder range of motion (ROM)
Range of motion (ROM) of affected shoulder, for abduction and external rotation. Mean difference between groups from baseline.
Measured: 3 months
Percentage of patients with at least 30% improvement of pain as per VNS scores (VNS30%)
Percentage of patients with at least 30% improvement of pain as per VAS scores (VAS30%). Mean difference between groups.
Measured: 1 month
Percentage of patients with at least 30% improvement of pain as per VNS scores (VNS30%)
Percentage of patients with at least 30% improvement of pain as per VAS scores (VAS30%). Mean difference between groups.
Measured: 3 months
Percentage of patients with at least 50% improvement of pain as per VNS scores (VNS50%)
Percentage of patients with at least 50% improvement of pain as per VAS scores (VAS30%). Mean difference between groups.
Measured: 1 month
Percentage of patients with at least 50% improvement of pain as per VNS scores (VNS50%)
Percentage of patients with at least 50% improvement of pain as per VAS scores (VAS30%). Mean difference between groups.
Measured: 3 months
Adverse events
Number of participants with adverse events. Mean difference between groups.
Measured: 1 month
Adverse events
Number of participants with adverse events. Mean difference between groups.
Measured: 3 months
Pain medication
Use of pain medication. Classified as "Increased", "Decreased", "Stable" or "Non-applicable" . Mean difference between groups.
Measured: 1 months
Pain medication
Use of pain medication. Classified as "Increased", "Decreased", "Stable" or "Non-applicable" . Mean difference between groups.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start3 Jan 2020
- Primary completion30 Nov 2023 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-mastectomy Pain SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind randomized controlled trial comparing the efficacy of TPI + standard of care (ACTIVE) versus sham TPI + standard of care(PLACEBO), with an intention-to-treat analysis
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Câncer de Barretos
- Responsible party
- Sponsor
- Investigators
- Christina May Moran de Brito, MD, PhD, Study director, Instituto do Câncer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267315
- Sponsor's protocol ID
- 1474/19
- Status last verified
- Oct 2023
- First submitted
- 29 Jan 2020
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wisotzky E, Hanrahan N, Lione TP, Maltser S. Deconstructing Postmastectomy Syndrome: Implications for Physiatric Management. Phys Med Rehabil Clin N Am. 2017 Feb;28(1):153-169. doi: 10.1016/j.pmr.2016.09.003.
PubMed 27912994
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trigger Point Injections for Post-Mastectomy Pain Syndrome: A Double-Blind Randomized Controlled Trial With Intention-to-Treat Analysis
- ClinicalTrials.gov ID
- NCT04267315
- Acronym / sponsor ID
- 1474/19
- Conditions
- Post-mastectomy Pain Syndrome, Myofascial Pain Syndrome, Trigger Point Pain, Myofascial, Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Collaborators
- Hospital de Câncer de Barretos
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 12 Feb 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.
Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain that persists for more than three months after a surgical breast procedure. It has 11-70% incidence in patients that underwent a breast surgery. It consists of mixed pain, frequently associated with myofascial pain, an specific type of muscular pain. Trigger point injections (TPI) are classically used for the treatment of myofascial pain in other painful conditions. However, there are no controlled trials assessing the efficacy of TPI in the treatment of PMPS. The intervention objective is to assess the efficacy of TPI in patients with PMPS, when associated with a comprehensive rehabilitation program and pain management.
Detailed description
INTRODUCTION: Post-Mastectomy Pain Syndrome (PMPS) is a chronic pain that persists for more than three months after a surgical breast procedure. It has 11-70% incidence in patients that underwent a breast surgery. It consists of mixed pain, frequently associated with myofascial pain. Trigger point injections (TPI) are classically used for the treatment of myofascial pain in other etiologies. However, there are no controlled trials assessing the efficacy of TPI in the treatment of PMPS
OBJECTIVE: Assess the efficacy of TPI in patients with PMPS, when associated with a comprehensive rehabilitation program and pain management.
METHODS: Double-blind randomized controlled trial with intention-to-treat analysis. Both groups will undergo standard of care delivered by Physiatrist blinded to group allocation. Active group will undergo TPI with 1% lidocaine in each identified trigger-point, weekly, for three consecutive weeks. Control group will undergo subcutaneous saline injection superficial to the same trigger points, with the same frequency and number of sessions. Primary outcome is the mean difference between groups for pain levels, as assessed by Visual Numeric Scale (VNS), from baseline to 3 months after the procedure.
STATISTICAL ANALYSIS: Difference between groups at baseline, one and three months after injection, using Analysis of Covariance (ANCOVA) for the following outcomes: VNS; Presence of active trigger points, Pressure pain threshold (PPT); Short-Form McGill Pain Questionnaire (SF-MPQ); Neuropathic Pain Symptom Inventory (NPSI); Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH); Range of motion (ROM) of affected shoulder, for abduction and external rotation; adverse events; use of pain medication.
Total sample size is 120. Alpha=5%, power=80%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomized controlled trial comparing the efficacy of TPI + standard of care (ACTIVE) versus sham TPI + standard of care(PLACEBO), with an intention-to-treat analysis
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Procedure: Trigger point injection, Other: Comprehensive Rehabilitation program3 weekly sessions of TPI. Participants will undergo 1mL injections of 1% lidocaine in the muscles identified with either active or latent trigger points at the initial assessment. The same muscles will be injected at all procedures. |
| Placebo | Sham comparator | Procedure: Subcutaneous saline injection, Other: Comprehensive Rehabilitation program3 weekly sessions of subcutaneous saline injections. Participants will undergo 0.2mL subcutaneous saline injections superficial to the trigger points identified at initial assessment. The same superficial sites will be injected in all procedures. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Breast cancer patients.
- PMPS diagnosis, as per Wisotzky et col.
- Pain Visual analog Scale (VAS) ≥4.
- At least one active trigger point in the following muscles: pectoralis major, superior trapezius, serratus anterior, levator scapularis, latissimus dorsi, infraspinatus
Key exclusion criteria (4 listed)
- Current radiation therapy or time since completion < 3months.
- Allergy to lidocaine or other local anesthetics
- Active infection over injection sites
- Unavailability to be at the hospital during study intervention.
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 |
|---|---|---|
| Trigger point injection1mL injections of 1% lidocaine in the muscles identified active trigger points at the day of intervention (pectoralis major, serratus anterior, levator scapulae, latissimus dorsi, infraspinatus). | Procedure or surgery | Active |
| Subcutaneous saline injection0.2mL subcutaneous saline injections superficial to the muscles identified with active trigger points at the day of intervention (pectoralis major, serratus anterior, levator scapulae, latissimus dorsi, infraspinatus). | Procedure or surgery | Placebo |
| Comprehensive Rehabilitation programPatients in both groups will undergo standard of care rehabilitation delivered by a Physiatrist, which may include Physical Therapy, Occupational Therapy, Exercise Physiologist, Rehabilitation Nurse, Psychologist, as per Physiatrist's prescription. Both the comprehensive rehabilitation program and pain medications will continue to be managed by participant's Physiatrist, who will be blinded to patient's allocation. The researchers will be responsible for TPI and for data collection. | Other | Active, Placebo |
Primary outcome
Visual Numeric Scale (VNS) for pain in 3 months
Time frame: 3 months
Mean difference of Pain between groups from baseline to 3 months(T3m), assessed by the Visual Numeric Scale (VNS, 0-10), in which higher scores represent higher pain intensity.
Trigger-points
Time frame: 1 month
Number of active trigger-points in the assessed muscles (latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior). Mean difference between groups.
Trigger-points
Time frame: 3 months
Number of active trigger-points in the assessed muscles (latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior). Mean difference between groups.
Pressure Pain Threshold (PPT)
Time frame: 1 month
Pressure Pain Threshold (PPT) at bilateral latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior. Difference from baseline
Pressure Pain Threshold
Time frame: 3 months
Pressure Pain Threshold (PPT) at bilateral latissimus dorsi, levator scapulae, trapezius superior, infraspinatus, pectoralis major, serratus anterior. Difference from baseline
17 secondary outcomes
Visual Numeric Scale (VNS) for pain in 1 month
Time frame: 1 month
Short-Form McGill Pain Questionnaire (SF-MPQ) - total score, sensorial and affective scale
Time frame: 1 month
Short-Form McGill Pain Questionnaire (SF-MPQ) - total score, sensorial and affective scale
Time frame: 3 months
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: 1 month.
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: 3 months
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Time frame: 1 month
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Time frame: 3 months
Shoulder range of motion (ROM)
Time frame: 1 month
Shoulder range of motion (ROM)
Time frame: 3 months
Percentage of patients with at least 30% improvement of pain as per VNS scores (VNS30%)
Time frame: 1 month
Percentage of patients with at least 30% improvement of pain as per VNS scores (VNS30%)
Time frame: 3 months
Percentage of patients with at least 50% improvement of pain as per VNS scores (VNS50%)
Time frame: 1 month
Percentage of patients with at least 50% improvement of pain as per VNS scores (VNS50%)
Time frame: 3 months
Adverse events
Time frame: 1 month
Adverse events
Time frame: 3 months
Pain medication
Time frame: 1 months
Pain medication
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Background: PubMed 27912994Wisotzky E, Hanrahan N, Lione TP, Maltser S. Deconstructing Postmastectomy Syndrome: Implications for Physiatric Management. Phys Med Rehabil Clin N Am. 2017 Feb;28(1):153-169. doi: 10.1016/j.pmr.2016.09.003.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina May Moran de Brito, MD, PhD study director
Instituto do Câncer do Estado de São Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trigger point injection, Subcutaneous saline injection and Comprehensive Rehabilitation program in people with Post-mastectomy Pain Syndrome and Myofascial Pain Syndrome, run by Instituto do Cancer do Estado de São Paulo at 2 sites in Brazil.
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 4 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 16 Oct 2023. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Visual Numeric Scale (VNS) for pain in 3 months (time frame: 3 months). The study lists 5 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 NCT04267315, which also lists 1 linked publication.
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 16 Oct 2023.