Low Back PainNCT03237104
Back in the Game: An Immediate Functional Progression Program in Athletes With a Spondylolysis.
An observational study of Low Back Pain and Spondylosis, run by Nationwide Children's Hospital at 5 sites in United States.
Trial summary
Half of all adolescents report experiencing low back pain (LBP), and adolescents who are active in sport report an even higher rate. The most common identifiable cause of LBP in the adolescent athlete is a stress fracture in the low back, known as a spondylolysis. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Low Back Pain, Spondylosis
- What is being tested?
- Immediate PT
- How many people
- 12 participants
- Where
- 5 sitesUnited States
- Study dates
- 31 Jul 2017to 8 Jan 2021
- 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 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The population of interest is young athletes with a recent spondylolysis injury.
Who may be able to join
- Age 10-19 years old
- Diagnosed with a spondylolysis through magnetic resonance imaging (MRI) with active signs of healing. Signs of active healing are defined as edema noted on MRI.
- Participates in organized sport
Who cannot join
- Previous rest from activity >4 weeks without improved symptoms
- Red flags present (bowel/bladder problems, saddle anesthesia, progressive neurological deficits, recent fever or infection, unexplained weight loss, unable to change symptoms with mechanical testing)
- Numbness and tingling in any lumbar dermatome
- Other injury or condition that would alter the plan of care for spondylolysis (i.e. pregnancy, anterior cruciate ligament (ACL) tear, concussion)
- History of lumbar surgery
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Nationwide Children's Hospital Sports and Ortho PT Ortho Center
Columbus, Ohio, 43205
Nationwide Children's Hospital Sports and Ortho PT East Broad
Columbus, Ohio, 43213
Nationwide Children's Hospital Sports and Ortho PT Dublin
Dublin, Ohio, 43017
Nationwide Children's Hospital Sports and Ortho PT New Albany
New Albany, Ohio, 43054
Nationwide Children's Hospital Sports and Ortho PT Westerville
Westerville, Ohio, 43082
About this study
Official title: Back in the Game: A Pilot Study Assessing an Immediate Functional Progression Program in Athletes With a Spondylolysis.
Half of all adolescents report experiencing low back pain (LBP), and adolescents who are active in sport report an even higher rate. The most common identifiable cause of LBP in the adolescent athlete is a stress fracture in the low back, known as a spondylolysis. Spondylolysis injuries have been found in up 47% of young athletes with LBP. The current recommendations of care for a spondylolysis consist of rest for at least 3 months, bracing, and physical therapy. These recommendations result in athletes being out of sport for as long as 46 months, and are based on low level evidence and expert opinion. In addition to the long period out of sport, 42% have poor long-term outcomes, and 1 in 6 athletes are no longer able to play at their former level specifically due to their back injury. These long periods out of sport and poor long-term clinical outcomes suggest current care recommendations are suboptimal.
The overall objective of the proposed research is to test the feasibility of using an early functional progression program to reduce athletes' time out of sport and improve clinical outcomes. Specifically, to pilot altering the rest period in athletes with a spondylolysis and begin rehabilitation immediately. These young athletes will return to sport as they are able, after demonstrating predetermined pain free functional ability. Twelve young athletes with a confirmed active spondylolysis will be recruited to undergo the early function progression intervention. The specific aims of this study are to assess the feasibility of implementing the immediate functional progression protocol, refine the protocol if necessary, and estimate potential effectiveness of this intervention. The athletes' outcomes will be compared to historical controls. The investigators hypothesize that the immediate functional progression program can be successfully implemented and with only minor changes will be suitable for use in larger trials. It is estimated the immediate functional progression program has the potential to return athletes to sport more than a month sooner than current practice. Once able to demonstrate the feasibility of the early functional progression program, the investigators plan to progress this work into larger trials to fully assess effectiveness, safety and long-term outcomes.
Read the detailed description
Athletes who meet the inclusion criteria and consent to participate in the pilot study will be referred directly to physical therapy (PT) care for 2 times per week. Athletes will follow-up with their co-investigating physician every 4 weeks until discharge. The immediate functional progression program will be performed by physical therapists trained in the treatment protocol. Athletes will perform phase I of the program and progress to phase II as able without an increase in pain and without compensations noted in function. The athlete will be assessed at each session to determine if they meet the criteria to begin the next step of functional progression program. Once the athlete has met the criteria of phase II, they will progress into the final phase of the functional progression program for return to sport activity. As these athletes progress through the third phase, and are able to meet the return to sport criteria, they will be released to return to sport. Athletes will not be released to return to sport prior to their first physician follow-up visit at 4 weeks.
Phase I Immediate Functional Progression Program Core strengthening in neutral spine Treat directional preference if identified Hip strengthening Peri-scapular strengthening Flexibility exercises Manual Therapy as needed Modalities for pain (use sparingly)
Phase II Immediate Functional Progression Program Core strengthening in functional range Hip and peri-scapular strengthening Flexibility exercises Manual Therapy (use sparingly) Phase III Immediate Functional Progression Program- Return to Sport Return to sport activity with focus on functional return to all aspect of sport.
Signs of not responding as anticipated during the immediate functional progression program: Inability to meet long-term goals of care in PT including inability to return to sport due to low back pain within three months, an increase in pain or no significant decrease in pain (<2/10) at physician visits until patient reports <2/10 pain with activity.
Sample Size A sample size of 12 will be recruited for this pilot trial. As there is a nonlinear relationship between confidence interval (CI) width and sample size, further increases in participants beyond 12 have a diminishing benefit on precision for preliminary studies.
Data Analysis Descriptive statistics of the patient demographics and outcome variables will be reported. Inferential calculations will not be performed as this is a pilot to demonstrate the feasibility of implementing the proposed immediate functional progression program.
Aim 1: Discussion of the success of implementing the immediate functional progression program will occur during and after care of each patient. The PI will monitor patient documentation to assess adherence to the research protocol in care. Adverse events will be monitored, the immediate functional progression program will be considered acceptably tolerated by patients if <3 adverse events are observed.
Aim 2: (Potential Problems and Alternative strategies) Minor problems identified in the pilot study will serve to refine to the protocol for the full randomized clinical trial. Larger potential problems include non-adherence to the experimental treatment protocol. The risk of this potential problem will be reduced by training of all staff involved in the research process. If a problem is found in the experiment protocol that inhibits patients from satisfactorily progressing in their care, the co-investigators will meet and decide on a course of action to fix this issue. An alteration in the experimental protocol that results in improved care would be considered a positive outcome, as the goal of this pilot study is to demonstrate viability and feasibility for a larger clinical trial.
Aim 3: Clinical outcomes including pain, function, time to return to sport and recurrence of symptoms will be compared against historical controls to assess for potential efficacy. Historical controls for quality of life are not available in this population. Time to return to sport will be the primary outcome of interest. A decrease in return to sport time of > 30 days compared to the historical control time of 3.8 months without a notable worsening of other outcomes will indicate future research is warranted.
- Conditions
- Low Back Pain, Spondylosis
- Being tested
- Immediate PT
- Keywords
- Adolescent, Athlete
- Medical subject headings
- Low Back Pain, Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate PTOther
Athletes will perform phase I (neutral spine) of the program and progress to phase II (functional motion) as able without an increase in pain and without compensations noted in function. The athlete will be assessed at each session to determine if they meet the criteria to begin the next step of functional progression program. Once the athlete has met the criteria of phase II, they will progress into the final phase of the functional progression program for return to sport activity. As these athletes progress through the third phase, and are able to meet the return to sport criteria, they will be released to return to sport. Athletes will not be released to return to sport prior to their first physician follow-up visit at 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| acute spondylolysis | Athletes who meet the inclusion criteria and consent to participate in the pilot study will be referred directly to PT care for 2 times per week until cleared to return to sport. Receives: Other: Immediate PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to return to sport (days)
The number of days from diagnosis of spondylolysis to the point the patient passes all criteria of the PT program and is cleared to return to sport by the physician
Measured: 1-6 months
Secondary outcomes (5)
Change in Micheli Functional Scale (MFS)
Function
Measured: Baseline, 1 month, 3 months, 6 months, 1 year
Change in Numeric Pain Rating Scale
Pain
Measured: Baseline, 1 month, 3 months, 6 months, 1 year
Recurrence of low back symptoms
Patients will be asked if there low back pain (must have impaired ability to play sport or activities of daily living)
Measured: Baseline, 1 month, 3 months, 6 months, 1 year
adverse reaction
An adverse reaction will be defined as 1) lumbar symptoms increasing enough to cause an unplanned visit to a physician or 2) the patient being placed on hold from therapy during the episode of care
Measured: 1-6 months
Change in MRI
Patients will have a repeat MRI performed at 3 months. A radiologist will assess for change in the spondylolytic lesion, edema and anterolisthesis.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start31 Jul 2017
- Primary completion31 Oct 2020
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitchell Selhorst, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237104
- Sponsor's protocol ID
- IRB17-00258
- Status last verified
- Jan 2021
- First submitted
- 31 Jul 2017
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Anderson K, Sarwark JF, Conway JJ, Logue ES, Schafer MF. Quantitative assessment with SPECT imaging of stress injuries of the pars interarticularis and response to bracing. J Pediatr Orthop. 2000 Jan-Feb;20(1):28-33.
PubMed 10641684Klein G, Mehlman CT, McCarty M. Nonoperative treatment of spondylolysis and grade I spondylolisthesis in children and young adults: a meta-analysis of observational studies. J Pediatr Orthop. 2009 Mar;29(2):146-56. doi: 10.1097/BPO.0b013e3181977fc5.
PubMed 19352240Selhorst M, Fischer A, Graft K, Ravindran R, Peters E, Rodenberg R, Welder E, MacDonald J. Timing of Physical Therapy Referral in Adolescent Athletes With Acute Spondylolysis: A Retrospective Chart Review. Clin J Sport Med. 2017 May;27(3):296-301. doi: 10.1097/JSM.0000000000000334.
PubMed 27347866Selhorst M, Fischer A, Graft K, Ravindran R, Peters E, Rodenberg R, MacDonald J. Long-Term Clinical Outcomes and Factors That Predict Poor Prognosis in Athletes After a Diagnosis of Acute Spondylolysis: A Retrospective Review With Telephone Follow-up. J Orthop Sports Phys Ther. 2016 Dec;46(12):1029-1036. doi: 10.2519/jospt.2016.7028. Epub 2016 Nov 8.
PubMed 27825292
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Back in the Game: A Pilot Study Assessing an Immediate Functional Progression Program in Athletes With a Spondylolysis.
- ClinicalTrials.gov ID
- NCT03237104
- Acronym / sponsor ID
- IRB17-00258
- Conditions
- Low Back Pain, Spondylosis
- Keywords
- Adolescent, Athlete
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 2 Aug 2017 (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.
Half of all adolescents report experiencing low back pain (LBP), and adolescents who are active in sport report an even higher rate. The most common identifiable cause of LBP in the adolescent athlete is a stress fracture in the low back, known as a spondylolysis. Spondylolysis injuries have been found in up 47% of young athletes with LBP. The current recommendations of care for a spondylolysis consist of rest for at least 3 months, bracing, and physical therapy. These recommendations result in athletes being out of sport for as long as 46 months, and are based on low level evidence and expert opinion. In addition to the long period out of sport, 42% have poor long-term outcomes, and 1 in 6 athletes are no longer able to play at their former level specifically due to their back injury. These long periods out of sport and poor long-term clinical outcomes suggest current care recommendations are suboptimal.
The overall objective of the proposed research is to test the feasibility of using an early functional progression program to reduce athletes' time out of sport and improve clinical outcomes. Specifically, to pilot altering the rest period in athletes with a spondylolysis and begin rehabilitation immediately. These young athletes will return to sport as they are able, after demonstrating predetermined pain free functional ability. Twelve young athletes with a confirmed active spondylolysis will be recruited to undergo the early function progression intervention. The specific aims of this study are to assess the feasibility of implementing the immediate functional progression protocol, refine the protocol if necessary, and estimate potential effectiveness of this intervention. The athletes' outcomes will be compared to historical controls. The investigators hypothesize that the immediate functional progression program can be successfully implemented and with only minor changes will be suitable for use in larger trials. It is estimated the immediate functional progression program has the potential to return athletes to sport more than a month sooner than current practice. Once able to demonstrate the feasibility of the early functional progression program, the investigators plan to progress this work into larger trials to fully assess effectiveness, safety and long-term outcomes.
Detailed description
Athletes who meet the inclusion criteria and consent to participate in the pilot study will be referred directly to physical therapy (PT) care for 2 times per week. Athletes will follow-up with their co-investigating physician every 4 weeks until discharge. The immediate functional progression program will be performed by physical therapists trained in the treatment protocol. Athletes will perform phase I of the program and progress to phase II as able without an increase in pain and without compensations noted in function. The athlete will be assessed at each session to determine if they meet the criteria to begin the next step of functional progression program. Once the athlete has met the criteria of phase II, they will progress into the final phase of the functional progression program for return to sport activity. As these athletes progress through the third phase, and are able to meet the return to sport criteria, they will be released to return to sport. Athletes will not be released to return to sport prior to their first physician follow-up visit at 4 weeks.
Phase I Immediate Functional Progression Program Core strengthening in neutral spine Treat directional preference if identified Hip strengthening Peri-scapular strengthening Flexibility exercises Manual Therapy as needed Modalities for pain (use sparingly)
Phase II Immediate Functional Progression Program Core strengthening in functional range Hip and peri-scapular strengthening Flexibility exercises Manual Therapy (use sparingly) Phase III Immediate Functional Progression Program- Return to Sport Return to sport activity with focus on functional return to all aspect of sport.
Signs of not responding as anticipated during the immediate functional progression program: Inability to meet long-term goals of care in PT including inability to return to sport due to low back pain within three months, an increase in pain or no significant decrease in pain (<2/10) at physician visits until patient reports <2/10 pain with activity.
Sample Size A sample size of 12 will be recruited for this pilot trial. As there is a nonlinear relationship between confidence interval (CI) width and sample size, further increases in participants beyond 12 have a diminishing benefit on precision for preliminary studies.
Data Analysis Descriptive statistics of the patient demographics and outcome variables will be reported. Inferential calculations will not be performed as this is a pilot to demonstrate the feasibility of implementing the proposed immediate functional progression program.
Aim 1: Discussion of the success of implementing the immediate functional progression program will occur during and after care of each patient. The PI will monitor patient documentation to assess adherence to the research protocol in care. Adverse events will be monitored, the immediate functional progression program will be considered acceptably tolerated by patients if <3 adverse events are observed.
Aim 2: (Potential Problems and Alternative strategies) Minor problems identified in the pilot study will serve to refine to the protocol for the full randomized clinical trial. Larger potential problems include non-adherence to the experimental treatment protocol. The risk of this potential problem will be reduced by training of all staff involved in the research process. If a problem is found in the experiment protocol that inhibits patients from satisfactorily progressing in their care, the co-investigators will meet and decide on a course of action to fix this issue. An alteration in the experimental protocol that results in improved care would be considered a positive outcome, as the goal of this pilot study is to demonstrate viability and feasibility for a larger clinical trial.
Aim 3: Clinical outcomes including pain, function, time to return to sport and recurrence of symptoms will be compared against historical controls to assess for potential efficacy. Historical controls for quality of life are not available in this population. Time to return to sport will be the primary outcome of interest. A decrease in return to sport time of > 30 days compared to the historical control time of 3.8 months without a notable worsening of other outcomes will indicate future research is warranted.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute spondylolysis | – | Other: Immediate PTAthletes who meet the inclusion criteria and consent to participate in the pilot study will be referred directly to PT care for 2 times per week until cleared to return to sport. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The population of interest is young athletes with a recent spondylolysis injury.
Key inclusion criteria (3 listed)
- Age 10-19 years old
- Diagnosed with a spondylolysis through magnetic resonance imaging (MRI) with active signs of healing. Signs of active healing are defined as edema noted on MRI.
- Participates in organized sport
Key exclusion criteria (5 listed)
- Previous rest from activity >4 weeks without improved symptoms
- Red flags present (bowel/bladder problems, saddle anesthesia, progressive neurological deficits, recent fever or infection, unexplained weight loss, unable to change symptoms with mechanical testing)
- Numbness and tingling in any lumbar dermatome
- Other injury or condition that would alter the plan of care for spondylolysis (i.e. pregnancy, anterior cruciate ligament (ACL) tear, concussion)
- History of lumbar surgery
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 |
|---|---|---|
| Immediate PTAthletes will perform phase I (neutral spine) of the program and progress to phase II (functional motion) as able without an increase in pain and without compensations noted in function. The athlete will be assessed at each session to determine if they meet the criteria to begin the next step of functional progression program. Once the athlete has met the criteria of phase II, they will progress into the final phase of the functional progression program for return to sport activity. As these athletes progress through the third phase, and are able to meet the return to sport criteria, they will be released to return to sport. Athletes will not be released to return to sport prior to their first physician follow-up visit at 4 weeks. | Other | acute spondylolysis |
Primary outcome
Time to return to sport (days)
Time frame: 1-6 months
The number of days from diagnosis of spondylolysis to the point the patient passes all criteria of the PT program and is cleared to return to sport by the physician
5 secondary outcomes
Change in Micheli Functional Scale (MFS)
Time frame: Baseline, 1 month, 3 months, 6 months, 1 year
Change in Numeric Pain Rating Scale
Time frame: Baseline, 1 month, 3 months, 6 months, 1 year
Recurrence of low back symptoms
Time frame: Baseline, 1 month, 3 months, 6 months, 1 year
adverse reaction
Time frame: 1-6 months
Change in MRI
Time frame: Baseline, 3 months
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 11 Jan 2021.
- Background: PubMed 10641684Anderson K, Sarwark JF, Conway JJ, Logue ES, Schafer MF. Quantitative assessment with SPECT imaging of stress injuries of the pars interarticularis and response to bracing. J Pediatr Orthop. 2000 Jan-Feb;20(1):28-33.
- Background: PubMed 19352240Klein G, Mehlman CT, McCarty M. Nonoperative treatment of spondylolysis and grade I spondylolisthesis in children and young adults: a meta-analysis of observational studies. J Pediatr Orthop. 2009 Mar;29(2):146-56. doi: 10.1097/BPO.0b013e3181977fc5.
- Results publication: PubMed 27347866Selhorst M, Fischer A, Graft K, Ravindran R, Peters E, Rodenberg R, Welder E, MacDonald J. Timing of Physical Therapy Referral in Adolescent Athletes With Acute Spondylolysis: A Retrospective Chart Review. Clin J Sport Med. 2017 May;27(3):296-301. doi: 10.1097/JSM.0000000000000334.
- Results publication: PubMed 27825292Selhorst M, Fischer A, Graft K, Ravindran R, Peters E, Rodenberg R, MacDonald J. Long-Term Clinical Outcomes and Factors That Predict Poor Prognosis in Athletes After a Diagnosis of Acute Spondylolysis: A Retrospective Review With Telephone Follow-up. J Orthop Sports Phys Ther. 2016 Dec;46(12):1029-1036. doi: 10.2519/jospt.2016.7028. Epub 2016 Nov 8.
- Individual participant dataSharing planned: Undecided
Related trials for Low Back Pain
Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Not yet recruiting
Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain
Low Back Pain, Core Muscles
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Spondylosis, run by Nationwide Children's Hospital at 5 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 3 inclusion and 5 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 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Time to return to sport (days) (time frame: 1-6 months). 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 NCT03237104, which also lists 4 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 11 Jan 2021.