Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
University of New Mexico
Study ID
NCT06268704
Phase
PHASE4
Status
Recruiting
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Conditions

  • Sacro-Iliac Spondylosis
  • Sacroiliac Joint Dysfunction

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone — DRUG
    This is a non-particulate steroid commonly used to treat SI joint pain.
  • Methylprednisolone — DRUG
    This is a particulate steroid commonly used to treat SI joint pain.
  • 2% Lidocaine HCl Injection — DRUG
    Lidocaine is a local anesthetic used in SI joint injection procedures to numb the procedure site and helps to confirm SI joint dysfunction when injected with the steroid medication into the SI joint.

Study Details

This study will compare two different corticosteroids (dexamethasone and methylprednisolone) for use in sacroiliac joint injections to treat SI joint pain.

Key Dates

Start date
Mar 27, 2024
Status verified
Nov 2025
Primary completion
Jan 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Non-Particulate Steroid
    Patients in this arm will receive an injection of 1 milliliter of 2% lidocaine with 10 milligrams of dexamethasone to one or both sacroiliac joints. If participants initially achieve relief from the injection but then have a return of pain they may be offered a second injection with the same drug at the same dose.
  • Active Comparator: Particulate Steroid
    Patients in this arm will receive an injection of 1 milliliter of 2% lidocaine with 40 milligrams of methylprednisolone to one or both sacroiliac joints. If participants initially achieve relief from the injection but then have a return of pain they may be offered a second injection with the same drug at the same dose.

Primary Outcome Measure

Pain using Numeric Pain Rating Score [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of New Mexico HospitalAlbuquerqueNew Mexico87131
Mark W Shilling, BS
[email protected]
505-925-7599

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By research site
University of New Mexico Hospital· Albuquerque, NM

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