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Ketorolac Versus Corticosteroid Injections for Sacroiliac Joint Pain

Primary Purpose

Sacro-iliac Joint Pain

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Methylprednisolone Injection
Ketorolac Injection
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sacro-iliac Joint Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Michael G. DeGroote Pain Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Corticosteroid

Ketorolac

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 2, 2023
Last Updated
October 10, 2023
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT06081101
Brief Title
Ketorolac Versus Corticosteroid Injections for Sacroiliac Joint Pain
Official Title
Ultrasound Guided Sacroiliac Joint Injections With Ketorolac Versus Corticosteroid: A Prospective Non-inferiority Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacro-iliac Joint Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Corticosteroid
Arm Type
Active Comparator
Arm Description
Patients will receive ultrasound guided corticosteroid injection to see pain relief after injection
Arm Title
Ketorolac
Arm Type
Active Comparator
Arm Description
Patients will receive ultrasound guided ketorolac injection to see pain relief after injection
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone Injection
Intervention Description
Medication will be injected into SI joint under ultrasound guidance
Intervention Type
Drug
Intervention Name(s)
Ketorolac Injection
Intervention Description
Medication will be injected into SI joint under ultrasound guidance
Primary Outcome Measure Information:
Title
Sacroiliac (SI) joint pain
Description
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.
Time Frame
3 months following SI joint injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Akil Siva, MD
Phone
905-521-2100
Ext
44621
Email
akilsiva001@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Lee, MD
Email
michael.lee3@medportal.ca
Facility Information:
Facility Name
Michael G. DeGroote Pain Clinic
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Leone
Phone
905-521-2100
Ext
44621

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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
Citations:
PubMed Identifier
26031217
Citation
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Ketorolac Versus Corticosteroid Injections for Sacroiliac Joint Pain

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