Ketorolac Versus Corticosteroid Injections for Sacroiliac Joint Pain

NCT06081101 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: McMaster_University_KVC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sacro-iliac Joint Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months following SI joint injection

Study Arms (2)

Corticosteroid

ACTIVE COMPARATOR

Patients will receive ultrasound guided corticosteroid injection to see pain relief after injection

Drug: Methylprednisolone Injection

Ketorolac

ACTIVE COMPARATOR

Patients will receive ultrasound guided ketorolac injection to see pain relief after injection

Drug: Ketorolac Injection

Interventions

Methylprednisolone Injection DRUG

Medication will be injected into SI joint under ultrasound guidance

Corticosteroid

Ketorolac Injection DRUG

Medication will be injected into SI joint under ultrasound guidance

Ketorolac

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous back surgery
• Radicular leg pain
• Discogenic pain
• Myofascial pain syndrome
• Depression
• Systemic infection or localized infection at anticipated needle entry sites
• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Michael G. DeGroote Pain Clinic

Hamilton, Ontario, Canada

Location

Related Publications (15)

• 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.

  PMID: 26031217 BACKGROUND

• Aranke 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.

  PMID: 35769646 BACKGROUND

• Koh 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.

  PMID: 31083191 BACKGROUND

• Shapiro 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.

  PMID: 18780047 BACKGROUND

• Beitzel 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.

  PMID: 23809450 BACKGROUND

• Cooke 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.

  PMID: 33197813 BACKGROUND

• Xu 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.

  PMID: 30705607 BACKGROUND

• Taheri 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.

  PMID: 29417082 BACKGROUND

• Matava 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.

  PMID: 23016110 BACKGROUND

• Barkho 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.

  PMID: 29707458 BACKGROUND

• Jurgensmeier 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.

  PMID: 32950343 BACKGROUND

• Piuzzi 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.

  PMID: 30189436 BACKGROUND

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• Chiarotto 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.

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MeSH Terms

Interventions

Methylprednisolone; Ketorolac

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Akil Siva, MD

CONTACT

905-521-2100; akilsiva001@gmail.com

Michael Lee, MD

CONTACT

michael.lee3@medportal.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 12, 2023
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)