Sacro-iliac Joint PainEarly Phase 1NCT06081101
Ketorolac Versus Corticosteroid Injections for Sacroiliac Joint Pain
A Early Phase 1 study testing Methylprednisolone Injection and Ketorolac Injection in people with Sacro-iliac Joint Pain, run by McMaster University at 1 site in Canada.
Trial summary
This study will contribute to the current literature that have compared joint injections with steroid versus ketorolac providing evidence for the use of ketorolac for SI joint pain. Currently steroid is the clinical standard for joint injections, however with repetitive use, steroid injections can damage the joint. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sacro-iliac Joint Pain
- What is being tested?
- Methylprednisolone Injection and Ketorolac Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2025to Jul 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SI joint pain for at least 3 months
- Age greater than 18
- Must have at least 3 special tests positive for SI joint pain on physical exam
Who cannot join
- Previous back surgery
- Radicular leg pain
- Discogenic pain
- Myofascial pain syndrome
- Depression
- Systemic infection or localized infection at anticipated needle entry sites
Show all 13Show fewer
- Cognitive impairment preventing informed consent or accurate collection of data
- Patient allergic to medication used
- NSAID contraindications including:
- Gastrointestinal bleeds
- Renal failure
- Symptomatic congestive heart failure
- Cirrhosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Lee, MD contact
Canada1 site, 1 recruiting
- Recruiting
Michael G. DeGroote Pain Clinic
Hamilton, Ontario
Rebecca Leone, 905-521-2100 ext. 44621
About this study
Official title: Ultrasound Guided Sacroiliac Joint Injections With Ketorolac Versus Corticosteroid: A Prospective Non-inferiority Study
This study will contribute to the current literature that have compared joint injections with steroid versus ketorolac providing evidence for the use of ketorolac for SI joint pain. Currently steroid is the clinical standard for joint injections, however with repetitive use, steroid injections can damage the joint. Ketorolac is an alternative anti-inflammatory medication that does not cause the same joint damage and at a cheaper cost than steroid. The investigators hypothesize that ultrasound guided SI joint injections utilizing ketorolac provide the same pain relief as corticosteroid SI joint injections measured at 2, 6 and 12 weeks post injection. This would allow more frequent injections to control pain at a decreased cost to the healthcare system.
Read the detailed description
The majority of people will suffer from low back pain at some point in their life with 15-25% of axial low back pain originating at the sacroiliac (SI) joint. This pain is thought to be due to inflammation of the SI joint capsule, ligaments or bone. Following conservative management strategies such as mobility work, core strengthening and physiotherapy, as well as pharmacologic management, an SI joint injection would be the next treatment modality. Corticosteroid injections are currently the standard of care for joint injections. The corticosteroid minimizes pain by interrupting the bodies inflammatory cascade primarily by inhibiting the phospholipase A2 enzyme. However, with repetitive use, steroids can cause cartilaginous damage of the joint. With chondrocyte dysfunction being a key part of early osteoarthritis, these injections may expedite the arthritic joint changes. Due to this damage, physicians try to spread out joint injections as far as possible to reduce this risk even if the patient begins to experience more severe joint pain.
One possible alternative to steroids is the use of ketorolac, an non-steroidal anti-inflammatory drug (NSAID). Ketorolac joint injections have been shown to have similar pain reducing effects to steroids when used for shoulder, knee, hip and carpometacarpal joint pain. They have also been used widely in the National Football League to treat musculoskeletal injuries and in the post-operative phase to reduce opioid usage to manage pain. NSAIDS provide analgesia by inhibiting the cyclooxygenase (COX) family of enzymes that are involved with formation of prostaglandins. These prostaglandins are inflammatory mediators that promote inflammation and activates nociceptive neurotransmitters. Although there are known side effects of NSAIDs including increasing propensity for GI bleeds, kidney and liver disease, joint injections may have less systemic side effects compared to their oral counterparts. Another benefit of Ketorolac is the fact it is significantly cheaper than steroids. With less chondrotoxic effects, perhaps Ketorolac injections could be administered more frequently, not allowing the patient to have increasing pain levels, at less cost to the health care system even with more frequent administration.
- Conditions
- Sacro-iliac Joint Pain
- Being tested
- Methylprednisolone Injection, Ketorolac Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone InjectionDrug
Medication will be injected into SI joint under ultrasound guidance
Ketorolac InjectionDrug
Medication will be injected into SI joint under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid | Active comparator | Patients will receive ultrasound guided corticosteroid injection to see pain relief after injection Receives: Drug: Methylprednisolone Injection |
| Ketorolac | Active comparator | Patients will receive ultrasound guided ketorolac injection to see pain relief after injection Receives: Drug: Ketorolac Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sacroiliac (SI) joint pain
SI joint pain at 2, 6 and 12 week marks post SI joint injection measured on visual analogue scale. Higher numbers equate to worse pain and worse outcomes.
Measured: 3 months following SI joint injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Mar 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Sacro-iliac Joint PainStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081101
- Sponsor's protocol ID
- McMaster_University_KVC
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: All participant data will be kept on an encrypted device. Patient identifiers will not be used as patient will be matched with a randomized patient ID
Publications
Park KD, Kim TK, Bae BW, Ahn J, Lee WY, Park Y. Ultrasound guided intra-articular ketorolac versus corticosteroid injection in osteoarthritis of the hip: a retrospective comparative study. Skeletal Radiol. 2015 Sep;44(9):1333-40. doi: 10.1007/s00256-015-2174-9. Epub 2015 Jun 3.
PubMed 26031217Aranke M, McCrudy G, Rooney K, Patel K, Lee CA, Hasoon J, Kaye AD. Minimally Invasive and Conservative Interventions for the Treatment of Sacroiliac Joint Pain: A Review of Recent Literature. Orthop Rev (Pavia). 2022 May 31;14(4):34098. doi: 10.52965/001c.34098. eCollection 2022.
PubMed 35769646Koh SH, Lee SC, Lee WY, Kim J, Park Y. Ultrasound-guided intra-articular injection of hyaluronic acid and ketorolac for osteoarthritis of the carpometacarpal joint of the thumb: A retrospective comparative study. Medicine (Baltimore). 2019 May;98(19):e15506. doi: 10.1097/MD.0000000000015506.
PubMed 31083191Shapiro PS, Rohde RS, Froimson MI, Lash RH, Postak P, Greenwald AS. The effect of local corticosteroid or ketorolac exposure on histologic and biomechanical properties of rabbit tendon and cartilage. Hand (N Y). 2007 Dec;2(4):165-72. doi: 10.1007/s11552-007-9042-6. Epub 2007 May 5.
PubMed 18780047Beitzel K, McCarthy MB, Cote MP, Apostolakos J, Russell RP, Bradley J, ElAttrache NS, Romeo AA, Arciero RA, Mazzocca AD. The effect of ketorolac tromethamine, methylprednisolone, and platelet-rich plasma on human chondrocyte and tenocyte viability. Arthroscopy. 2013 Jul;29(7):1164-74. doi: 10.1016/j.arthro.2013.04.006.
PubMed 23809450Cooke C, Osborne J, Jackson N, Keating P, Flynn J, Markel D, Chen C, Lemos S. Acetaminophen, bupivacaine, Duramorph, and Toradol: A comparison of chondrocyte viability and gene expression changes in osteoarthritic human chondrocytes. Knee. 2020 Dec;27(6):1746-1752. doi: 10.1016/j.knee.2020.10.019. Epub 2020 Nov 13.
PubMed 33197813Xu J, Qu Y, Li H, Jiang T, Zheng C, Wang B, Shen P. Effect of ketorolac in intra-articular injection analgesia for postoperative pain in patients undergoing shoulder arthroscopy: a pilot-controlled clinical study. J Pain Res. 2019 Jan 17;12:417-422. doi: 10.2147/JPR.S178413. eCollection 2019.
PubMed 30705607Taheri P, Dehghan F, Mousavi S, Solouki R. Comparison of Subacromial Ketorolac Injection versus Corticosteroid Injection in the Treatment of Shoulder Impingement Syndrome. J Res Pharm Pract. 2017 Oct-Dec;6(4):223-227. doi: 10.4103/jrpp.JRPP_17_57.
PubMed 29417082Matava M, Brater DC, Gritter N, Heyer R, Rollins D, Schlegel T, Toto R, Yates A. Recommendations of the national football league physician society task force on the use of toradol((R)) ketorolac in the national football league. Sports Health. 2012 Sep;4(5):377-83. doi: 10.1177/1941738112457154.
PubMed 23016110Barkho JO, Li YK, Duku E, Thoma A. Ketorolac May Increase Hematoma Risk in Reduction Mammaplasty: A Case-control Study. Plast Reconstr Surg Glob Open. 2018 Mar 19;6(3):e1699. doi: 10.1097/GOX.0000000000001699. eCollection 2018 Mar.
PubMed 29707458Jurgensmeier K, Jurgensmeier D, Kunz DE, Fuerst PG, Warth LC, Daines SB. Intra-articular Injections of the Hip and Knee With Triamcinolone vs Ketorolac: A Randomized Controlled Trial. J Arthroplasty. 2021 Feb;36(2):416-422. doi: 10.1016/j.arth.2020.08.036. Epub 2020 Aug 22.
PubMed 32950343Piuzzi NS, Ng M, Kantor A, Ng K, Kha S, Mont MA, Muschler GF. What Is the Price and Claimed Efficacy of Platelet-Rich Plasma Injections for the Treatment of Knee Osteoarthritis in the United States? J Knee Surg. 2019 Sep;32(9):879-885. doi: 10.1055/s-0038-1669953. Epub 2018 Sep 6.
PubMed 30189436Bellamy JL, Goff BJ, Sayeed SA. Economic Impact of Ketorolac vs Corticosteroid Intra-Articular Knee Injections for Osteoarthritis: A Randomized, Double-Blind, Prospective Study. J Arthroplasty. 2016 Sep;31(9 Suppl):293-7. doi: 10.1016/j.arth.2016.05.015. Epub 2016 May 18.
PubMed 27402605D'Arcy Y, Mantyh P, Yaksh T, Donevan S, Hall J, Sadrarhami M, Viktrup L. Treating osteoarthritis pain: mechanisms of action of acetaminophen, nonsteroidal anti-inflammatory drugs, opioids, and nerve growth factor antibodies. Postgrad Med. 2021 Nov;133(8):879-894. doi: 10.1080/00325481.2021.1949199. Epub 2021 Jul 12.
PubMed 34252357Chiarotto A, Maxwell LJ, Ostelo RW, Boers M, Tugwell P, Terwee CB. Measurement Properties of Visual Analogue Scale, Numeric Rating Scale, and Pain Severity Subscale of the Brief Pain Inventory in Patients With Low Back Pain: A Systematic Review. J Pain. 2019 Mar;20(3):245-263. doi: 10.1016/j.jpain.2018.07.009. Epub 2018 Aug 10.
PubMed 30099210
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Sacroiliac Joint Injections With Ketorolac Versus Corticosteroid: A Prospective Non-inferiority Study
- ClinicalTrials.gov ID
- NCT06081101
- Acronym / sponsor ID
- McMaster_University_KVC
- Conditions
- Sacro-iliac Joint Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will contribute to the current literature that have compared joint injections with steroid versus ketorolac providing evidence for the use of ketorolac for SI joint pain. Currently steroid is the clinical standard for joint injections, however with repetitive use, steroid injections can damage the joint. Ketorolac is an alternative anti-inflammatory medication that does not cause the same joint damage and at a cheaper cost than steroid. The investigators hypothesize that ultrasound guided SI joint injections utilizing ketorolac provide the same pain relief as corticosteroid SI joint injections measured at 2, 6 and 12 weeks post injection. This would allow more frequent injections to control pain at a decreased cost to the healthcare system.
Detailed description
The majority of people will suffer from low back pain at some point in their life with 15-25% of axial low back pain originating at the sacroiliac (SI) joint. This pain is thought to be due to inflammation of the SI joint capsule, ligaments or bone. Following conservative management strategies such as mobility work, core strengthening and physiotherapy, as well as pharmacologic management, an SI joint injection would be the next treatment modality. Corticosteroid injections are currently the standard of care for joint injections. The corticosteroid minimizes pain by interrupting the bodies inflammatory cascade primarily by inhibiting the phospholipase A2 enzyme. However, with repetitive use, steroids can cause cartilaginous damage of the joint. With chondrocyte dysfunction being a key part of early osteoarthritis, these injections may expedite the arthritic joint changes. Due to this damage, physicians try to spread out joint injections as far as possible to reduce this risk even if the patient begins to experience more severe joint pain.
One possible alternative to steroids is the use of ketorolac, an non-steroidal anti-inflammatory drug (NSAID). Ketorolac joint injections have been shown to have similar pain reducing effects to steroids when used for shoulder, knee, hip and carpometacarpal joint pain. They have also been used widely in the National Football League to treat musculoskeletal injuries and in the post-operative phase to reduce opioid usage to manage pain. NSAIDS provide analgesia by inhibiting the cyclooxygenase (COX) family of enzymes that are involved with formation of prostaglandins. These prostaglandins are inflammatory mediators that promote inflammation and activates nociceptive neurotransmitters. Although there are known side effects of NSAIDs including increasing propensity for GI bleeds, kidney and liver disease, joint injections may have less systemic side effects compared to their oral counterparts. Another benefit of Ketorolac is the fact it is significantly cheaper than steroids. With less chondrotoxic effects, perhaps Ketorolac injections could be administered more frequently, not allowing the patient to have increasing pain levels, at less cost to the health care system even with more frequent administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid | Active comparator | Drug: Methylprednisolone InjectionPatients will receive ultrasound guided corticosteroid injection to see pain relief after injection |
| Ketorolac | Active comparator | Drug: Ketorolac InjectionPatients will receive ultrasound guided ketorolac injection to see pain relief after injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- SI joint pain for at least 3 months
- Age greater than 18
- Must have at least 3 special tests positive for SI joint pain on physical exam
Key exclusion criteria (13 listed)
- Previous back surgery
- Radicular leg pain
- Discogenic pain
- Myofascial pain syndrome
- Depression
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 |
|---|---|---|
| Methylprednisolone InjectionMedication will be injected into SI joint under ultrasound guidance | Drug | Corticosteroid |
| Ketorolac InjectionMedication will be injected into SI joint under ultrasound guidance | Drug | Ketorolac |
Primary outcome
Sacroiliac (SI) joint pain
Time frame: 3 months following SI joint injection
SI joint pain at 2, 6 and 12 week marks post SI joint injection measured on visual analogue scale. Higher numbers equate to worse pain and worse outcomes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 26031217Park KD, Kim TK, Bae BW, Ahn J, Lee WY, Park Y. Ultrasound guided intra-articular ketorolac versus corticosteroid injection in osteoarthritis of the hip: a retrospective comparative study. Skeletal Radiol. 2015 Sep;44(9):1333-40. doi: 10.1007/s00256-015-2174-9. Epub 2015 Jun 3.
- Background: PubMed 35769646Aranke M, McCrudy G, Rooney K, Patel K, Lee CA, Hasoon J, Kaye AD. Minimally Invasive and Conservative Interventions for the Treatment of Sacroiliac Joint Pain: A Review of Recent Literature. Orthop Rev (Pavia). 2022 May 31;14(4):34098. doi: 10.52965/001c.34098. eCollection 2022.
- Background: PubMed 31083191Koh SH, Lee SC, Lee WY, Kim J, Park Y. Ultrasound-guided intra-articular injection of hyaluronic acid and ketorolac for osteoarthritis of the carpometacarpal joint of the thumb: A retrospective comparative study. Medicine (Baltimore). 2019 May;98(19):e15506. doi: 10.1097/MD.0000000000015506.
- Background: PubMed 18780047Shapiro PS, Rohde RS, Froimson MI, Lash RH, Postak P, Greenwald AS. The effect of local corticosteroid or ketorolac exposure on histologic and biomechanical properties of rabbit tendon and cartilage. Hand (N Y). 2007 Dec;2(4):165-72. doi: 10.1007/s11552-007-9042-6. Epub 2007 May 5.
- Background: PubMed 23809450Beitzel K, McCarthy MB, Cote MP, Apostolakos J, Russell RP, Bradley J, ElAttrache NS, Romeo AA, Arciero RA, Mazzocca AD. The effect of ketorolac tromethamine, methylprednisolone, and platelet-rich plasma on human chondrocyte and tenocyte viability. Arthroscopy. 2013 Jul;29(7):1164-74. doi: 10.1016/j.arthro.2013.04.006.
- Background: PubMed 33197813Cooke C, Osborne J, Jackson N, Keating P, Flynn J, Markel D, Chen C, Lemos S. Acetaminophen, bupivacaine, Duramorph, and Toradol: A comparison of chondrocyte viability and gene expression changes in osteoarthritic human chondrocytes. Knee. 2020 Dec;27(6):1746-1752. doi: 10.1016/j.knee.2020.10.019. Epub 2020 Nov 13.
- Background: PubMed 30705607Xu J, Qu Y, Li H, Jiang T, Zheng C, Wang B, Shen P. Effect of ketorolac in intra-articular injection analgesia for postoperative pain in patients undergoing shoulder arthroscopy: a pilot-controlled clinical study. J Pain Res. 2019 Jan 17;12:417-422. doi: 10.2147/JPR.S178413. eCollection 2019.
- Background: PubMed 29417082Taheri P, Dehghan F, Mousavi S, Solouki R. Comparison of Subacromial Ketorolac Injection versus Corticosteroid Injection in the Treatment of Shoulder Impingement Syndrome. J Res Pharm Pract. 2017 Oct-Dec;6(4):223-227. doi: 10.4103/jrpp.JRPP_17_57.
- Background: PubMed 23016110Matava M, Brater DC, Gritter N, Heyer R, Rollins D, Schlegel T, Toto R, Yates A. Recommendations of the national football league physician society task force on the use of toradol((R)) ketorolac in the national football league. Sports Health. 2012 Sep;4(5):377-83. doi: 10.1177/1941738112457154.
- Background: PubMed 29707458Barkho JO, Li YK, Duku E, Thoma A. Ketorolac May Increase Hematoma Risk in Reduction Mammaplasty: A Case-control Study. Plast Reconstr Surg Glob Open. 2018 Mar 19;6(3):e1699. doi: 10.1097/GOX.0000000000001699. eCollection 2018 Mar.
- Background: PubMed 32950343Jurgensmeier K, Jurgensmeier D, Kunz DE, Fuerst PG, Warth LC, Daines SB. Intra-articular Injections of the Hip and Knee With Triamcinolone vs Ketorolac: A Randomized Controlled Trial. J Arthroplasty. 2021 Feb;36(2):416-422. doi: 10.1016/j.arth.2020.08.036. Epub 2020 Aug 22.
- Background: PubMed 30189436Piuzzi NS, Ng M, Kantor A, Ng K, Kha S, Mont MA, Muschler GF. What Is the Price and Claimed Efficacy of Platelet-Rich Plasma Injections for the Treatment of Knee Osteoarthritis in the United States? J Knee Surg. 2019 Sep;32(9):879-885. doi: 10.1055/s-0038-1669953. Epub 2018 Sep 6.
- Individual participant dataSharing planned: No. All participant data will be kept on an encrypted device. Patient identifiers will not be used as patient will be matched with a randomized patient ID
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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.
Michael Lee, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Methylprednisolone Injection and Ketorolac Injection in people with Sacro-iliac Joint Pain, run by McMaster University at 1 site in Canada.
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 13 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. 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 Canada. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akil Siva, MD (905-521-2100 ext. 44621, akilsiva001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sacroiliac (SI) joint pain (time frame: 3 months following SI joint injection). 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 NCT06081101, which also lists 15 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 9 Oct 2026.