Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06081101

Ketorolac Versus Corticosteroid Injections for Sacroiliac Joint Pain

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Michael G. DeGroote Pain Clinic

Hamilton, Ontario, Canada

Location contact

Rebecca Leone

CONTACT

905-521-2100 ext. 44621

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylprednisolone Injection

Drug

Medication will be injected into SI joint under ultrasound guidance

Ketorolac Injection

Drug

Medication will be injected into SI joint under ultrasound guidance

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Akil Siva, MD

CONTACT

[email protected]

905-521-2100 ext. 44621

Michael Lee, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

Ultrasound Guided Sacroiliac Joint Injections With Ketorolac Versus Corticosteroid: A Prospective Non-inferiority Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 12, 2023
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.