Ketorolac Versus Corticosteroid Injections for Sacroiliac Joint Pain

November 18, 2024 updated by: McMaster University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Michael G. DeGroote Pain Clinic
        • Contact:
          • Rebecca Leone
          • Phone Number: 44621 905-521-2100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Corticosteroid
Patients will receive ultrasound guided corticosteroid injection to see pain relief after injection
Drug: Methylprednisolone Injection
Medication will be injected into SI joint under ultrasound guidance
Active Comparator: Ketorolac
Patients will receive ultrasound guided ketorolac injection to see pain relief after injection
Drug: Ketorolac Injection
Medication will be injected into SI joint under ultrasound guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months following SI joint injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • McMaster_University_KVC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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