Recruiting
Early Phase 1

Ketorolac vs. Steroid

Sponsor:

McMaster University

Code:

NCT06081101

Conditions

Sacro-iliac Joint Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Methylprednisolone Injection

Ketorolac Injection

Study Details

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

Study ID

NCT06081101

Start date

Mar 1, 2025

Status verified date

Oct, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Corticosteroid

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

active comparator: Ketorolac

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

Interventions

Methylprednisolone Injection

Medication will be injected into SI joint under ultrasound guidance

Ketorolac Injection

Medication will be injected into SI joint under ultrasound guidance

Primary outcome measure

  • Sacroiliac (SI) joint pain [ Time Frame: 3 months following SI joint injection ]

Central Contacts and Locations

Central contacts

Akil Siva, MD

905-521-2100akilsiva001@gmail.com

Michael Lee, MD

michael.lee3@medportal.ca

Locations

Michael G. DeGroote Pain Clinic

Recruiting

Hamilton, Ontario, Canada

Contacts

Rebecca Leone

905-521-2100

More Information

Sponsor

McMaster University

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by McMaster University on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.