Chronic PainNCT05319691
Yoga for Chronic Low Back Pain in the Cleveland Clinic Employee Health Plan
A study testing Yoga in people with Chronic Pain and Back Pain, run by Robert Saper at 1 site in United States.
Trial summary
This study uses clinical trial and implementation science methodology to specifically assess the effectiveness of yoga into the management of chronic low back pain (cLBP) within the Cleveland Clinic Employee Health Plan. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chronic Pain, Back Pain
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2022to 15 Aug 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-64 years old
- Current non-specific LBP persisting ≥12 weeks with average pain intensity ≥4 for the previous week on an 11-point numerical rating scale
- Ability to speak and understand English
Who cannot join
- Any severe psychiatric or medical comorbidity in the Principal Investigator's judgment that would make study participation unsafe or not feasible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Yoga for Chronic Low Back Pain: A Type 1 Hybrid Implementation-Effectiveness Pragmatic Randomized Control Trial in the Cleveland Clinic Employee Health Plan
This study uses clinical trial and implementation science methodology to specifically assess the effectiveness of yoga into the management of chronic low back pain (cLBP) within the Cleveland Clinic Employee Health Plan. The study will use a type 1 hybrid effectiveness-implementation design, which tests a clinical intervention while collecting data on implementation. Studying and implementing evidence-based, non-pharmacologic interventions is an important strategy for improving pain management and reducing opioid use disorder.
Read the detailed description
The investigators will use a single (investigators) blinded two-arm randomized control trial (RCT) design. The trial will be 24 weeks long and divided into two distinct parts: an initial 12-week Treatment Phase followed by a 12-week Follow-up Phase. Participants will be randomized 1:1 into weekly virtual yoga classes (Yoga Now group) or a wait-list control (Yoga Later group) who will receive usual care. After the 24 week study period, participants in the Yoga Later Group will be offered the yoga intervention in a non-study format as well as a free yoga mat and access to online yoga for LBP videos.
The screening and enrollment process will all occur remotely and involves the following: 1) A telephone or Information Technology approved, The Health Insurance Portability and Accountability Act (HIPAA-secure), virtual meeting platform where participants provide consent for completion of eligibility screening through a standardized questionnaire; 2) if eligible, provision of information about the study presented by study personnel with use of an Institutional Review Board approved information page for informed consent, answering all questions about the study, and assuring participant understanding through the "teach back" method.
Randomization occurs after administering the baseline survey. Investigators will use a computerized randomization procedure built into the study management system, RedCap, to randomize each enrolled participant using a 1:1 ratio to the Yoga Now group or Yoga Later group. Permuted variably-sized block randomization with block sizes of 6, 12 and 18 will be used.
The study interventions start within approximately one week of baseline data collection and randomization. Participants will be asked to complete questionnaire forms at baseline, weeks 6, 12 and 24. All participants throughout the entire 24-week study can continue to receive routine medical care including doctor visits and pain medication.
The hatha yoga intervention, a term for yoga that pairs poses and breathing techniques, is structured and reproducible. The full instructor manual and participant manual are available online. Originally, it was developed by an expert panel led by Rob Saper, MD and Master of Public Health (MPH) in 2007 and used in a pilot study of 30 participants with cLBP. It was further refined in 2011 in a dosing study of 95 participants and a larger non-inferiority trial of 320. It is designed specifically for the yoga-naïve individual for effectiveness and safety in cLBP. Each class is 75 minutes long and will be delivered virtually to a maximum class size of 12. Yoga instructors will complete an 8-hour training on the protocol directed by the Cleveland Clinic lead yoga instructor.
Class begins with a relaxation exercise, yoga breathing exercises, and a brief discussion of yoga philosophy. The class proceeds with warm-up yoga exercises and then yoga postures. Yoga breathing is emphasized throughout. The class ends with a relaxation exercise. The 12 weeks are divided into four 3-week segments. Each segment is given a theme (e.g., "Listening to the Wisdom of the Body"). Participants are frequently advised to go slowly and carefully. The degree of difficulty of postures learned increases with each segment. For each segment, the participants gradually learn a sequence of 12-15 poses. The protocol provides variations and uses various aids (e.g., chair, strap) to accommodate a range of physical abilities. Participants are strongly encouraged to practice at home for 30 minutes daily on days which they do not attend yoga class. To facilitate home practice, participants will be given a free yoga mat, participant manual, and provided access to online videos prepared by the study instructors.
Ten percent of online yoga classes will be virtually observed and assessed by a study team member for instructor fidelity to the protocol using a checklist. A 12-week follow-up phase consisting of larger optional classes for maintenance will follow.
- Conditions
- Chronic Pain, Back Pain
- Being tested
- Yoga
- Medical subject headings
- Chronic Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Also called Treatment Group, Yoga Now
The trial will be 24 weeks long and divided into two distinct parts: an initial 12-week Treatment Phase during which, yoga participants will receive a reproducible standardized weekly yoga intervention delivered virtually with additional resources for home practice, followed by a 12-week Follow-up Phase.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Now (Treatment Group) | Active comparator | An initial 12-week Treatment Phase of weekly virtual yoga classes (Yoga Now) followed by a 12-week Follow-up Phase. Receives: Behavioral: Yoga |
| Yoga Later (Wait List Control Group) | No intervention | A wait-list control group (Yoga Later) will receive usual care. After the 24 week study period, participants in Yoga Later will be offered the yoga intervention in a non-study format. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported average pain intensity for the previous week
11 point numerical rating scale ranging from 0=no pain to 10=worst possible pain
Measured: Baseline
Change of self-reported average pain intensity for the previous week
11 point numerical rating scale ranging from 0=no pain to 10=worst possible pain
Measured: Week 12
Self-reported back-related function
Modified Roland Morris Disability Questionnaire ranging from 0=no functional impairment to 23=worst impairment of function
Measured: Baseline
Change of self-reported back-related function
Modified Roland Morris Disability Questionnaire ranging from 0=no functional impairment to 23=worst impairment of function
Measured: Week 12
Secondary outcomes (7)
Change of self-reported average pain intensity for the previous week
11 point numerical rating scale ranging from 0=no pain to 10=worst possible pain
Measured: Week 24
Change of self-reported back-related function
Modified Roland Morris Disability Questionnaire ranging from 0=no functional impairment to 23=worst impairment of function
Measured: Week 24
Analgesic use
Self-reported pain medications usage; dosage reported in milligrams
Measured: Baseline
Analgesic use
Change of self-reported pain medications usage; dosage reported in milligrams
Measured: Week 12
Analgesic use
Change of self-reported pain medications usage; dosage reported in milligrams
Measured: Week 24
Global improvement
Overall improvement by self-report (6-point Likert scale, 1 = very worse to 6 = very improved).
Measured: Weeks 12 and 24
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Pain Interference - Short Form 4a
PROMIS Pain domain asks 4 questions. Each question is rated from 1 to 5. Values are summed to create a total raw score. Raw scores are minimum 4 to maximum 20 and translate to a T score with a minimum 41.6 to maximum 75.6. A higher score equates to a higher pain interference.
Measured: Weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start3 May 2022
- Primary completion30 May 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigators will use a single-blinded (investigator) two-arm randomized control trial (RCT) design. The trial will be 24 weeks long and divided into two distinct parts: an initial 12-week Treatment Phase followed by a 12-week Follow-up Phase. Participants will be randomized 1:1 into weekly virtual yoga classes (Yoga Now) or a wait-list control (Yoga Later) who will receive usual care. After the 24 week study period, participants in Yoga Later will be offered the yoga intervention in a non-study format.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Saper
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor-investigator, Robert Saper, The Cleveland Clinic
- Investigators
- Robert B Saper, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319691
- Sponsor's protocol ID
- 22-132
- Status last verified
- Apr 2024
- First submitted
- 4 Feb 2022
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
PubMed 22310560Saper RB, Sherman KJ, Delitto A, Herman PM, Stevans J, Paris R, Keosaian JE, Cerrada CJ, Lemaster CM, Faulkner C, Breuer M, Weinberg J. Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial. Trials. 2014 Feb 26;15:67. doi: 10.1186/1745-6215-15-67.
PubMed 24568299Saper RB, Sherman KJ, Cullum-Dugan D, Davis RB, Phillips RS, Culpepper L. Yoga for chronic low back pain in a predominantly minority population: a pilot randomized controlled trial. Altern Ther Health Med. 2009 Nov-Dec;15(6):18-27.
PubMed 19943573Saper RB, Boah AR, Keosaian J, Cerrada C, Weinberg J, Sherman KJ. Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial. Evid Based Complement Alternat Med. 2013;2013:658030. doi: 10.1155/2013/658030. Epub 2013 Jun 26.
PubMed 23878604Saper RB, Lemaster C, Delitto A, Sherman KJ, Herman PM, Sadikova E, Stevans J, Keosaian JE, Cerrada CJ, Femia AL, Roseen EJ, Gardiner P, Gergen Barnett K, Faulkner C, Weinberg J. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Ann Intern Med. 2017 Jul 18;167(2):85-94. doi: 10.7326/M16-2579. Epub 2017 Jun 20.
PubMed 28631003Tankha H, Gaskins D, Shallcross A, Rothberg M, Hu B, Guo N, Roseen EJ, Dombrowski S, Bar J, Warren R, Wilgus H, Tate P, Goldfarb J, Drago VG, Saper R. Effectiveness of Virtual Yoga for Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2442339. doi: 10.1001/jamanetworkopen.2024.42339.
PubMed 39485352
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga for Chronic Low Back Pain: A Type 1 Hybrid Implementation-Effectiveness Pragmatic Randomized Control Trial in the Cleveland Clinic Employee Health Plan
- ClinicalTrials.gov ID
- NCT05319691
- Acronym / sponsor ID
- 22-132
- Conditions
- Chronic Pain, Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Robert SaperUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- 3 May 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 8 Apr 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.
This study uses clinical trial and implementation science methodology to specifically assess the effectiveness of yoga into the management of chronic low back pain (cLBP) within the Cleveland Clinic Employee Health Plan. The study will use a type 1 hybrid effectiveness-implementation design, which tests a clinical intervention while collecting data on implementation. Studying and implementing evidence-based, non-pharmacologic interventions is an important strategy for improving pain management and reducing opioid use disorder.
Detailed description
The investigators will use a single (investigators) blinded two-arm randomized control trial (RCT) design. The trial will be 24 weeks long and divided into two distinct parts: an initial 12-week Treatment Phase followed by a 12-week Follow-up Phase. Participants will be randomized 1:1 into weekly virtual yoga classes (Yoga Now group) or a wait-list control (Yoga Later group) who will receive usual care. After the 24 week study period, participants in the Yoga Later Group will be offered the yoga intervention in a non-study format as well as a free yoga mat and access to online yoga for LBP videos.
The screening and enrollment process will all occur remotely and involves the following: 1) A telephone or Information Technology approved, The Health Insurance Portability and Accountability Act (HIPAA-secure), virtual meeting platform where participants provide consent for completion of eligibility screening through a standardized questionnaire; 2) if eligible, provision of information about the study presented by study personnel with use of an Institutional Review Board approved information page for informed consent, answering all questions about the study, and assuring participant understanding through the "teach back" method.
Randomization occurs after administering the baseline survey. Investigators will use a computerized randomization procedure built into the study management system, RedCap, to randomize each enrolled participant using a 1:1 ratio to the Yoga Now group or Yoga Later group. Permuted variably-sized block randomization with block sizes of 6, 12 and 18 will be used.
The study interventions start within approximately one week of baseline data collection and randomization. Participants will be asked to complete questionnaire forms at baseline, weeks 6, 12 and 24. All participants throughout the entire 24-week study can continue to receive routine medical care including doctor visits and pain medication.
The hatha yoga intervention, a term for yoga that pairs poses and breathing techniques, is structured and reproducible. The full instructor manual and participant manual are available online. Originally, it was developed by an expert panel led by Rob Saper, MD and Master of Public Health (MPH) in 2007 and used in a pilot study of 30 participants with cLBP. It was further refined in 2011 in a dosing study of 95 participants and a larger non-inferiority trial of 320. It is designed specifically for the yoga-naïve individual for effectiveness and safety in cLBP. Each class is 75 minutes long and will be delivered virtually to a maximum class size of 12. Yoga instructors will complete an 8-hour training on the protocol directed by the Cleveland Clinic lead yoga instructor.
Class begins with a relaxation exercise, yoga breathing exercises, and a brief discussion of yoga philosophy. The class proceeds with warm-up yoga exercises and then yoga postures. Yoga breathing is emphasized throughout. The class ends with a relaxation exercise. The 12 weeks are divided into four 3-week segments. Each segment is given a theme (e.g., "Listening to the Wisdom of the Body"). Participants are frequently advised to go slowly and carefully. The degree of difficulty of postures learned increases with each segment. For each segment, the participants gradually learn a sequence of 12-15 poses. The protocol provides variations and uses various aids (e.g., chair, strap) to accommodate a range of physical abilities. Participants are strongly encouraged to practice at home for 30 minutes daily on days which they do not attend yoga class. To facilitate home practice, participants will be given a free yoga mat, participant manual, and provided access to online videos prepared by the study instructors.
Ten percent of online yoga classes will be virtually observed and assessed by a study team member for instructor fidelity to the protocol using a checklist. A 12-week follow-up phase consisting of larger optional classes for maintenance will follow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Investigators will use a single-blinded (investigator) two-arm randomized control trial (RCT) design. The trial will be 24 weeks long and divided into two distinct parts: an initial 12-week Treatment Phase followed by a 12-week Follow-up Phase. Participants will be randomized 1:1 into weekly virtual yoga classes (Yoga Now) or a wait-list control (Yoga Later) who will receive usual care. After the 24 week study period, participants in Yoga Later will be offered the yoga intervention in a non-study format.
| Arm | Type | Receives |
|---|---|---|
| Yoga Now (Treatment Group) | Active comparator | Behavioral: YogaAn initial 12-week Treatment Phase of weekly virtual yoga classes (Yoga Now) followed by a 12-week Follow-up Phase. |
| Yoga Later (Wait List Control Group) | No intervention | –A wait-list control group (Yoga Later) will receive usual care. After the 24 week study period, participants in Yoga Later will be offered the yoga intervention in a non-study format. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-64 years old
- Current non-specific LBP persisting ≥12 weeks with average pain intensity ≥4 for the previous week on an 11-point numerical rating scale
- Ability to speak and understand English
Key exclusion criteria (1 listed)
- Any severe psychiatric or medical comorbidity in the Principal Investigator's judgment that would make study participation unsafe or not feasible.
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 |
|---|---|---|
| YogaAlso: Treatment Group, Yoga NowThe trial will be 24 weeks long and divided into two distinct parts: an initial 12-week Treatment Phase during which, yoga participants will receive a reproducible standardized weekly yoga intervention delivered virtually with additional resources for home practice, followed by a 12-week Follow-up Phase. | Behavioural | Yoga Now (Treatment Group) |
Primary outcome
Self-reported average pain intensity for the previous week
Time frame: Baseline
11 point numerical rating scale ranging from 0=no pain to 10=worst possible pain
Change of self-reported average pain intensity for the previous week
Time frame: Week 12
11 point numerical rating scale ranging from 0=no pain to 10=worst possible pain
Self-reported back-related function
Time frame: Baseline
Modified Roland Morris Disability Questionnaire ranging from 0=no functional impairment to 23=worst impairment of function
Change of self-reported back-related function
Time frame: Week 12
Modified Roland Morris Disability Questionnaire ranging from 0=no functional impairment to 23=worst impairment of function
7 secondary outcomes
Change of self-reported average pain intensity for the previous week
Time frame: Week 24
Change of self-reported back-related function
Time frame: Week 24
Analgesic use
Time frame: Baseline
Analgesic use
Time frame: Week 12
Analgesic use
Time frame: Week 24
Global improvement
Time frame: Weeks 12 and 24
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Pain Interference - Short Form 4a
Time frame: Weeks 12 and 24
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 29 Apr 2024.
- Background: PubMed 22310560Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
- Background: PubMed 24568299Saper RB, Sherman KJ, Delitto A, Herman PM, Stevans J, Paris R, Keosaian JE, Cerrada CJ, Lemaster CM, Faulkner C, Breuer M, Weinberg J. Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial. Trials. 2014 Feb 26;15:67. doi: 10.1186/1745-6215-15-67.
- Background: PubMed 19943573Saper RB, Sherman KJ, Cullum-Dugan D, Davis RB, Phillips RS, Culpepper L. Yoga for chronic low back pain in a predominantly minority population: a pilot randomized controlled trial. Altern Ther Health Med. 2009 Nov-Dec;15(6):18-27.
- Background: PubMed 23878604Saper RB, Boah AR, Keosaian J, Cerrada C, Weinberg J, Sherman KJ. Comparing Once- versus Twice-Weekly Yoga Classes for Chronic Low Back Pain in Predominantly Low Income Minorities: A Randomized Dosing Trial. Evid Based Complement Alternat Med. 2013;2013:658030. doi: 10.1155/2013/658030. Epub 2013 Jun 26.
- Background: PubMed 28631003Saper RB, Lemaster C, Delitto A, Sherman KJ, Herman PM, Sadikova E, Stevans J, Keosaian JE, Cerrada CJ, Femia AL, Roseen EJ, Gardiner P, Gergen Barnett K, Faulkner C, Weinberg J. Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial. Ann Intern Med. 2017 Jul 18;167(2):85-94. doi: 10.7326/M16-2579. Epub 2017 Jun 20.
- Derived from this study: PubMed 39485352Tankha H, Gaskins D, Shallcross A, Rothberg M, Hu B, Guo N, Roseen EJ, Dombrowski S, Bar J, Warren R, Wilgus H, Tate P, Goldfarb J, Drago VG, Saper R. Effectiveness of Virtual Yoga for Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2442339. doi: 10.1001/jamanetworkopen.2024.42339.
- 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.
Robert B Saper, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Chronic Pain and Back Pain, run by Robert Saper at 1 site 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 1 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 29 Apr 2024. 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 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?
Self-reported average pain intensity for the previous week (time frame: Baseline). The study lists 4 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 NCT05319691, which also lists 6 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 29 Apr 2024.