Clinical Trial Finder

Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 99 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Aged >18, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, capable of attending all planned follow up visits.
  • - Unilateral low back/buttocks pain of at least 2 weeks.
  • - Patient reported 7 day average of numeric pain rating score (NPRS) low back/buttocks pain of at least 5/10 at baseline evaluation.
  • - Clinical diagnosis of sacroiliac joint pain as diagnosed by a board certified Physiatrist including history of low back/buttocks pain and at least 2 positive physical exam findings (including positive fortin finger sign, pain with palpation of posterior superior iliac spine, positive FABER's test, positive Gaenslan's test, positive sacral distraction, positive thigh thrust, positive lateral compression, positive sacral thrust) - Patient consents to sacroiliac joint corticosteroid injection in a shared decision-making process with the treating physician.
  • - 80% or more relief of index pain within first 5-15 minutes after injection.

Exclusion Criteria:

  • - Clinical suspicion of alternative process is greater than clinical suspicion of sacroiliac joint pain.
  • - Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).
  • - Those involved in active litigation relevant to their pain.
  • - Those unable to read English and complete the assessment instruments.
  • - Those unable to attend follow up appointments.
  • - The patient is incarcerated.
  • - History of prior sacroiliac joint fusion.
  • - Progressive lower extremity neurologic deficit (from active radiculopathy, unhealed radiculopathy, or neuromuscular disease) - Sacroiliac joint steroid injection within the prior 12 months.
  • - 2 Positive lumbar medial branch blocks within the past 12 months.
  • - Radiofrequency ablation of the lumbar spine within the past 12 months.
  • - Lumbar facet steroid injections within the past 12 months.
  • - Prior epidural steroid injection within the prior 3 months in any location within the spine.
  • - Possible pregnancy or other reason that precludes the use of fluoroscopy.
  • - Allergy to steroid, contrast media, or local anesthetics.
  • - BMI>40.
  • - Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus).
  • - Active infection or treatment of infection with antibiotics within the past 7 days.
  • - Medical conditions causing significant functional disability (e.g., stroke, decompensated ---COPD, decompensated heart failure) - Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).
  • - Addictive behavior, severe clinical depression, or psychotic features.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06268704
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of New Mexico
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Reza Ehsanian, MD, PhD
Principal Investigator Affiliation University of New Mexico Department of Anesthesiology and Critical Care
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Sacroiliac Joint Dysfunction, Sacro-Iliac Spondylosis
Additional Details

Patients who are screened for inclusion will be randomized into one of two groups; dexamethasone or methylprednisolone. Patients will report their pain immediately after the procedure to confirm the diagnosis of sacroiliac joint pain, then be followed for three months to compare the efficacy and safety of the two medications.

Arms & Interventions

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.

Interventions

Drug: - Dexamethasone

This is a non-particulate steroid commonly used to treat SI joint pain.

Drug: - Methylprednisolone

This is a particulate steroid commonly used to treat SI joint pain.

Drug: - 2% Lidocaine HCl Injection

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of New Mexico Hospital, Albuquerque, New Mexico

Status

Recruiting

Address

University of New Mexico Hospital

Albuquerque, New Mexico, 87131

Site Contact

Mark W Shilling, BS

[email protected]

505-925-7599

Powered By