Musculoskeletal ManipulationsNCT05209659
Applying Pain Adaptability to Manual Therapy Practice
An observational study of Musculoskeletal Manipulations and Low Back Pain, run by Youngstown State University at 3 sites in United States.
Trial summary
Mechanism research has identified pain adaptive and non-adaptive phenotypes by documenting the response to an ice immersion bath. Pain adaptive individuals exhibited a rapid response to cold and a rapid resolution of symptoms with continued exposure. Non-pain adaptive individuals had the opposite. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Manipulations, Low Back Pain
- What is being tested?
- Pragmatic Mobilization
- Type of treatment
- Injection or infusion
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Feb 2022to 31 Dec 2022
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Individuals whom fit inclusion/exclusion criteria will be recruited from outpatient orthopedic clinics via convenience sample as well as recruited from university and community sites across a geographically diverse segment of the United States.
Who may be able to join
- History of lumbar spine pain in the past 12 months
- Ability to reproduce low back discomfort with PA mobilization
Who cannot join
- Demonstration of any signs of upper motor neuron lesion including unexplained loss of function of bowel/bladder, unexplained gait changes, pathologic hyper-reflexia.
- Diagnosis which contradicts the application of prolonged cold including but not limited to severe vascular disease, open wounds/sores on involved extremity.
- Diagnosis which contradicts the application of joint mobilizations including but not limited to instability, inflammatory conditions, severe osteoporosis.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Tri County Physical Therapy Institute
Canfield, Ohio, 44406
David Griswold, PhD, 330-533-1080, DWGriswold@ysu.edu
David Griswold, PhD
- Recruiting
The Therapy Institute
Haslett, Michigan, 48840
Stephen Houghton, 517-339-4050, houghton.sm@gmail.com
- Recruiting
Old Bridge Spine and Wellness
Old Bridge, New Jersey, 08857
Michael Zolotnitsky, DPT, 732-757-5430, Michael.Zolotnisky@spineandwellness.com
About this study
Mechanism research has identified pain adaptive and non-adaptive phenotypes by documenting the response to an ice immersion bath. Pain adaptive individuals exhibited a rapid response to cold and a rapid resolution of symptoms with continued exposure. Non-pain adaptive individuals had the opposite. Pain-adaptive individuals have the endogenous (internal) capacity to self-modulate pain therefore may pursue active self management techniques, whereas non-pain adaptive phenotypes may be more prone to use of external mechanisms (e.g., analgesic medications) for pain relief. A pain adaptive individual is likely to benefit from all forms of conservative active or passive pain modulatory treatments and is expected to have a favorable prognosis. Although this finding is useful, ice bath immersion is an impractical assessment for clinical practice, leaving clinicians with the inability to identify pain adaptive individuals.
Emerging evidence indicates that an associative clinical response associated with an early within session (during the first visit) and between session (from the first to the second visit) during a posterior to anterior mobilization, identifies individuals who have a favorable prognosis with spinal pain. While neurophysiological basis for the analgesic effect of manual therapy has been proposed to date no one has investigated if the associative clinical response is purely another way of identifying pain adaptive or non-pain adaptive individuals. If a within-session or between-session response is associated with the pain adaptive mechanism found during an ice-bath immersion, clinicians could adopt the clinical evaluation technique and improve their ability to identify proper patients for management. The investigators will evaluate the relationship between the pain adaptive mechanistic response from ice-bath immersion and the associative clinical response that occurs during a PA mobilization of the spine.
Read the detailed description
This proof-of-concept study uses an observational design to assess correlation between the below stated factors. This study design has been recommended in analgesic management in investigating novel mechanistic relationships. A convenience sample will be recruited from outpatient orthopedic clinics and University sites across a geographically diverse segment of the United States. Individuals will be educated on the purpose and risks of the study via informed consent and will determine if they would like to participate. An a priori power analysis was performed at the .05 significance level with a projected correlation of (.60) and a sample size of 28 participants was recommended to achieve 80 percent power. Given the single session design with virtual/electronic follow up a low dropout rate related to compliance is anticipated. Given the noxious application and the ability to terminate session if requested, along with aforementioned, a total drop-out rate of 10% will be anticipated. A sample size of 32 will be utilized in an attempt to obtain 28 participants.
Data collection will be completed by investigators and/or clinicians whom have been trained directly by investigators on the research protocol or by the research team.
Following consent, the individuals will follow the protocol below:
- Baseline patient reported measurements will be obtained including McGill Pain Questionnaire, Fear Avoidance Belief Questionnaire, Modified Oswestry Low Back Pain Disability Questionnaire, Expectations of Treatment Scale, Hospital Anxiety and Depression Scale, Fatigue Severity Scale, Numeric Pain Rating Scale (NPRS) (current, best, and worst)
- Baseline Demographics which have shown prognostic value
- Age
- Gender
- Symptom Duration
- Joint(s) involved
- Presence of referred leg pain
- Baseline Objective measures will be obtained including:
- Active Range of Motion at lumbar spine and Coxofemoral joint
- Neuromuscular Screening (Reflexes, light touch sensation L3-S1, neural testing)
- Cardiopulmonary screening (Blood pressure, heart rate, pulse-oximetry, AAA)
- Joint mobility at lumbosacral spine via Posterior -> Anterior (PA) mobilizations performed central and unilateral; Assess for comparable sign, If present progress to below
- Pain modulation/adaptability assessment - Protocol outlined below:
- Application of non-thrust Central or Unilateral PA mobilization application as chosen by the clinician in a pragmatic manner to address patients comparable sign.
- Technique, grade, time, and location to be recorded
- Pain (NPRS) to be graded continuously throughout the technique and recorded Pain Adaptability/Modulation assessment: Throughout the experiment, the participants will sit comfortably in a chair with arms rested on the arm rests and legs testing on the floor. The room temperature will be controlled at 21-23 deg C. Participants will be assured that cold stimulation will not cause any physical damage to their body, and are allowed to withdraw from the experiments at any time. Cold pressor pain
- A bucket of ice and water, a temperature of 1.0C to 4.0C will be maintained by stirring regularly to prevent an increase of water temperature surrounding the hand.
- Participants will submerge their left hand to 5cm above the wrist with their palm facing down. They will be encouraged to keep their hand in the water for 5 minutes. If they find the pain becoming intolerable, they can withdraw their hand immediately.
- Pain intensity - During the cold stimulation, participants will be asked to rate the intensity of pain continuously using a 0 to 10 NPRS (0 = no pain at all; 10 = worst pain possible).
- McGill Pain Questionnaire (MPQ) - will be completed after cold stimulation. The MPQ is designed to provide qualitative and quantitative measures of pain that can be examined statistically. The MPQ consists of 4 major classes of word descriptors (sensory, affective, evaluative, and miscellaneous) for participants to specify subjective pain experience.
- Pressure pain threshold (PPT) - An electronic pressure algometer (Pain Test FPX 25) with a probe area of 1 cm squared will be used. Participants will indicate when the pressure stimulus becomes just painful. PPT's will be determined by averaging 3 assessments taken at 1-minute intervals. It will take 2 to 3 minutes to complete the PPT tests, which will lead to some participants undertaking a 6-minute cold stimulation test.
- Sensory assessment - All PPT assessments will be tested at 3 sites: bilateral extensor carpi radialis, at 3 cm distal to the lateral end of the cubic crease on the elbow, and on the right soleus at 8 cm proximal to medial malleolus.
- All PPT Assessments will be performed before, during (3 minutes after the initiation of cold stimulation), and 20 minutes post termination of Cold Stimulation.
- 2-week follow up via phone call, text message, email, or virtual meeting to assess NPRS and GROC.
- Conditions
- Musculoskeletal Manipulations, Low Back Pain
- Being tested
- Pragmatic Mobilization
- Keywords
- Pan Adaptability
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pragmatic MobilizationOther
Also called Mobilization, Mobilisation
The techniques will of consist of passive, low velocity, oscillatory movements within the physiological range of the joint, applied to the comparable spinal level of the patient (defined as the spinal level that reproduced the patient's familiar pain). The techniques will be modified based on clinician assessment and patient feedback and consist of Grade I through Grade IV movements. Common techniques used may include unilateral posterior-anterior movements, central posterior-anterior movements, and sidelying rotations (without thrust). Since the pragmatic approach is clinician-driven, no time limit will be placed on the application and the number of mobilizations used will depend on the patient feedback (the exact definition of a pragmatic treatment). Patients will be seen for 4 visits.
Other Name: Non-thrust manipulation (pragmatically applied)
| Study group | Role | What they receive |
|---|---|---|
| Low Back Pain | Pragmatic Mobilization The pragmatically applied non-thrust manipulation will be based on the original concepts outlined by Maitland and will of consist of passive, low velocity, oscillatory movements within the physiological range of the joint, applied to the comparable spinal level of the patient (defined as the spinal level that reproduced the patient's familiar pain). The techniques will be modified based on clinician assessment and patient feedback and consist of Grade I through Grade IV movements. Since the pragmatic approach is clinician-driven, no time limit will be placed on the application and the number of mobilizations used will depend on the patient feedback (the exact definition of a pragmatic treatment) Receives: Other: Pragmatic Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Numeric Pain Rating Scale is a self-reported pain scale which has demonstrated validity and reliability in dealing with multiple pain complaints including chronic spine pain. The scale ranges from 0 to 10 with 0 indicating no perceived pain and 10 indicating maximum perceived pain possible. Aminimally clinically importance difference (MCID) of 1 to 1.7 points or 30% improvement has been suggested.
Measured: collected at baseline and continuously during 5 minute cold pressor test: 2-week follow up via phone call, text message, email, or virtual meeting
Global Rating of Change
The Global Rating of Change scale is a self-reported scale ranging from -7 (a very great deal worse) to +7 (a very great deal better) with a score of 0 indicating no change from baseline. This scale has demonstrated reliability and validity in assessment of self-reported improvement in the physical therapy profession. Psychometric assessments of this tool have been somewhat limited as it is often utilized as the criterion measure in the assessment of other instruments. A MCID of 2-2.5 points has been suggested.
Measured: collected at 2-week follow up via phone call, text message, email, or virtual meeting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start15 Feb 2022
- Primary completion17 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal ManipulationsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Youngstown State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damian Keter, Youngstown State University
- Investigators
- Kenneth Learman, PhD, Study chair, Professor, Department of Graduate Studies in Health and Rehabilitation Sciences, Youngstown State University, Youngstown, OhioSeverine Van Slambrouck, PhD, Study director, IRB Director, Youngstown State University, Youngstown, OhioDamian L Keter, Principal investigator, Student, Youngstown State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209659
- Sponsor's protocol ID
- 290
- Status last verified
- Sep 2022
- First submitted
- 10 Jan 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Pain Adaptability to Manual Therapy Practice
- ClinicalTrials.gov ID
- NCT05209659
- Acronym / sponsor ID
- 290
- Conditions
- Musculoskeletal Manipulations, Low Back Pain
- Keywords
- Pan Adaptability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Youngstown State UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 17 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Jan 2022 (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.
Mechanism research has identified pain adaptive and non-adaptive phenotypes by documenting the response to an ice immersion bath. Pain adaptive individuals exhibited a rapid response to cold and a rapid resolution of symptoms with continued exposure. Non-pain adaptive individuals had the opposite. Pain-adaptive individuals have the endogenous (internal) capacity to self-modulate pain therefore may pursue active self management techniques, whereas non-pain adaptive phenotypes may be more prone to use of external mechanisms (e.g., analgesic medications) for pain relief. A pain adaptive individual is likely to benefit from all forms of conservative active or passive pain modulatory treatments and is expected to have a favorable prognosis. Although this finding is useful, ice bath immersion is an impractical assessment for clinical practice, leaving clinicians with the inability to identify pain adaptive individuals.
Emerging evidence indicates that an associative clinical response associated with an early within session (during the first visit) and between session (from the first to the second visit) during a posterior to anterior mobilization, identifies individuals who have a favorable prognosis with spinal pain. While neurophysiological basis for the analgesic effect of manual therapy has been proposed to date no one has investigated if the associative clinical response is purely another way of identifying pain adaptive or non-pain adaptive individuals. If a within-session or between-session response is associated with the pain adaptive mechanism found during an ice-bath immersion, clinicians could adopt the clinical evaluation technique and improve their ability to identify proper patients for management. The investigators will evaluate the relationship between the pain adaptive mechanistic response from ice-bath immersion and the associative clinical response that occurs during a PA mobilization of the spine.
Detailed description
This proof-of-concept study uses an observational design to assess correlation between the below stated factors. This study design has been recommended in analgesic management in investigating novel mechanistic relationships. A convenience sample will be recruited from outpatient orthopedic clinics and University sites across a geographically diverse segment of the United States. Individuals will be educated on the purpose and risks of the study via informed consent and will determine if they would like to participate. An a priori power analysis was performed at the .05 significance level with a projected correlation of (.60) and a sample size of 28 participants was recommended to achieve 80 percent power. Given the single session design with virtual/electronic follow up a low dropout rate related to compliance is anticipated. Given the noxious application and the ability to terminate session if requested, along with aforementioned, a total drop-out rate of 10% will be anticipated. A sample size of 32 will be utilized in an attempt to obtain 28 participants.
Data collection will be completed by investigators and/or clinicians whom have been trained directly by investigators on the research protocol or by the research team.
Following consent, the individuals will follow the protocol below:
- Baseline patient reported measurements will be obtained including McGill Pain Questionnaire, Fear Avoidance Belief Questionnaire, Modified Oswestry Low Back Pain Disability Questionnaire, Expectations of Treatment Scale, Hospital Anxiety and Depression Scale, Fatigue Severity Scale, Numeric Pain Rating Scale (NPRS) (current, best, and worst)
- Baseline Demographics which have shown prognostic value
- Age
- Gender
- Symptom Duration
- Joint(s) involved
- Presence of referred leg pain
- Baseline Objective measures will be obtained including:
- Active Range of Motion at lumbar spine and Coxofemoral joint
- Neuromuscular Screening (Reflexes, light touch sensation L3-S1, neural testing)
- Cardiopulmonary screening (Blood pressure, heart rate, pulse-oximetry, AAA)
- Joint mobility at lumbosacral spine via Posterior -> Anterior (PA) mobilizations performed central and unilateral; Assess for comparable sign, If present progress to below
- Pain modulation/adaptability assessment - Protocol outlined below:
- Application of non-thrust Central or Unilateral PA mobilization application as chosen by the clinician in a pragmatic manner to address patients comparable sign.
- Technique, grade, time, and location to be recorded
- Pain (NPRS) to be graded continuously throughout the technique and recorded Pain Adaptability/Modulation assessment: Throughout the experiment, the participants will sit comfortably in a chair with arms rested on the arm rests and legs testing on the floor. The room temperature will be controlled at 21-23 deg C. Participants will be assured that cold stimulation will not cause any physical damage to their body, and are allowed to withdraw from the experiments at any time. Cold pressor pain
- A bucket of ice and water, a temperature of 1.0C to 4.0C will be maintained by stirring regularly to prevent an increase of water temperature surrounding the hand.
- Participants will submerge their left hand to 5cm above the wrist with their palm facing down. They will be encouraged to keep their hand in the water for 5 minutes. If they find the pain becoming intolerable, they can withdraw their hand immediately.
- Pain intensity - During the cold stimulation, participants will be asked to rate the intensity of pain continuously using a 0 to 10 NPRS (0 = no pain at all; 10 = worst pain possible).
- McGill Pain Questionnaire (MPQ) - will be completed after cold stimulation. The MPQ is designed to provide qualitative and quantitative measures of pain that can be examined statistically. The MPQ consists of 4 major classes of word descriptors (sensory, affective, evaluative, and miscellaneous) for participants to specify subjective pain experience.
- Pressure pain threshold (PPT) - An electronic pressure algometer (Pain Test FPX 25) with a probe area of 1 cm squared will be used. Participants will indicate when the pressure stimulus becomes just painful. PPT's will be determined by averaging 3 assessments taken at 1-minute intervals. It will take 2 to 3 minutes to complete the PPT tests, which will lead to some participants undertaking a 6-minute cold stimulation test.
- Sensory assessment - All PPT assessments will be tested at 3 sites: bilateral extensor carpi radialis, at 3 cm distal to the lateral end of the cubic crease on the elbow, and on the right soleus at 8 cm proximal to medial malleolus.
- All PPT Assessments will be performed before, during (3 minutes after the initiation of cold stimulation), and 20 minutes post termination of Cold Stimulation.
- 2-week follow up via phone call, text message, email, or virtual meeting to assess NPRS and GROC.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Back Pain | – | Other: Pragmatic MobilizationPragmatic Mobilization The pragmatically applied non-thrust manipulation will be based on the original concepts outlined by Maitland and will of consist of passive, low velocity, oscillatory movements within the physiological range of the joint, applied to the comparable spinal level of the patient (defined as the spinal level that reproduced the patient's familiar pain). The techniques will be modified based on clinician assessment and patient feedback and consist of Grade I through Grade IV movements. Since the pragmatic approach is clinician-driven, no time limit will be placed on the application and the number of mobilizations used will depend on the patient feedback (the exact definition of a pragmatic treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals whom fit inclusion/exclusion criteria will be recruited from outpatient orthopedic clinics via convenience sample as well as recruited from university and community sites across a geographically diverse segment of the United States.
Key inclusion criteria (2 listed)
- History of lumbar spine pain in the past 12 months
- Ability to reproduce low back discomfort with PA mobilization
Key exclusion criteria (3 listed)
- Demonstration of any signs of upper motor neuron lesion including unexplained loss of function of bowel/bladder, unexplained gait changes, pathologic hyper-reflexia.
- Diagnosis which contradicts the application of prolonged cold including but not limited to severe vascular disease, open wounds/sores on involved extremity.
- Diagnosis which contradicts the application of joint mobilizations including but not limited to instability, inflammatory conditions, severe osteoporosis.
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 |
|---|---|---|
| Pragmatic MobilizationAlso: Mobilization, MobilisationThe techniques will of consist of passive, low velocity, oscillatory movements within the physiological range of the joint, applied to the comparable spinal level of the patient (defined as the spinal level that reproduced the patient's familiar pain). The techniques will be modified based on clinician assessment and patient feedback and consist of Grade I through Grade IV movements. Common techniques used may include unilateral posterior-anterior movements, central posterior-anterior movements, and sidelying rotations (without thrust). Since the pragmatic approach is clinician-driven, no time limit will be placed on the application and the number of mobilizations used will depend on the patient feedback (the exact definition of a pragmatic treatment). Patients will be seen for 4 visits. Other Name: Non-thrust manipulation (pragmatically applied) | Other | Low Back Pain |
Primary outcome
Numeric Pain Rating Scale
Time frame: collected at baseline and continuously during 5 minute cold pressor test: 2-week follow up via phone call, text message, email, or virtual meeting
Numeric Pain Rating Scale is a self-reported pain scale which has demonstrated validity and reliability in dealing with multiple pain complaints including chronic spine pain. The scale ranges from 0 to 10 with 0 indicating no perceived pain and 10 indicating maximum perceived pain possible. Aminimally clinically importance difference (MCID) of 1 to 1.7 points or 30% improvement has been suggested.
Global Rating of Change
Time frame: collected at 2-week follow up via phone call, text message, email, or virtual meeting
The Global Rating of Change scale is a self-reported scale ranging from -7 (a very great deal worse) to +7 (a very great deal better) with a score of 0 indicating no change from baseline. This scale has demonstrated reliability and validity in assessment of self-reported improvement in the physical therapy profession. Psychometric assessments of this tool have been somewhat limited as it is often utilized as the criterion measure in the assessment of other instruments. A MCID of 2-2.5 points has been suggested.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
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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.
Kenneth Learman, PhD study chair
Professor, Department of Graduate Studies in Health and Rehabilitation Sciences, Youngstown State University, Youngstown, Ohio
Severine Van Slambrouck, PhD study director
IRB Director, Youngstown State University, Youngstown, Ohio
Damian L Keter principal investigator
Student, Youngstown State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Manipulations and Low Back Pain, run by Youngstown State University at 3 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 2 inclusion and 3 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 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damian L Keter, DPT, PhD(c) (216-791-3800 ext. 61113, dlketer@student.ysu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: collected at baseline and continuously during 5 minute cold pressor test: 2-week follow up via phone call, text message, email, or virtual meeting). 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?
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 29 Sep 2022.