Steroid Injections for Sacroiliac Joint Dysfunction

Recruiting in Palo Alto (17 mi)

Overseen by Reza Ehsanian, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of New Mexico

Disqualifiers: Systemic inflammatory arthritis, Chronic widespread pain, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have had certain steroid injections or treatments in the past year, you may not be eligible to participate.

What evidence supports the effectiveness of the drug for sacroiliac joint dysfunction?

Research shows that corticosteroid injections, like methylprednisolone, into the sacroiliac joint can provide significant and lasting pain relief, especially in conditions like seronegative spondylarthropathy, with about 80% of patients experiencing rapid improvement.

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Are steroid injections for sacroiliac joint dysfunction safe?

Research indicates that MR-guided steroid injections into the sacroiliac joints are generally safe, with no complications reported in studies involving patients with conditions like spondylarthropathy. These injections do not involve radiation, making them safe for repeated use.

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How do steroid injections for sacroiliac joint dysfunction differ from other treatments?

Steroid injections like Dexamethasone and Methylprednisolone for sacroiliac joint dysfunction provide rapid and lasting pain relief, especially in inflammatory conditions, and can be guided by imaging techniques like MRI or CT for precision, which is not common in all treatments.

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Eligibility Criteria

This trial is for adults over 18 with unilateral low back or buttocks pain lasting at least two weeks, and a pain score of at least 5/10. They must have been diagnosed with sacroiliac joint pain by a specialist and shown significant improvement after an initial injection. Participants need to understand English, consent to treatment, and be able to attend follow-ups.

Inclusion Criteria

I am over 18, understand English, can follow study procedures, and can attend all follow-up visits.

My average pain in my lower back or buttocks is at least 5 out of 10.

I agree to receive a corticosteroid injection in my sacroiliac joint.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an injection of either dexamethasone or methylprednisolone to the sacroiliac joints

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Multiple visits (in-person)

Participant Groups

The study compares the effectiveness of two corticosteroids—dexamethasone and methylprednisolone—injected into the sacroiliac joint for relieving SI joint pain. It also involves an initial numbing agent (2% Lidocaine) during the procedure.

Group I: Non-Particulate Steroid Experimental Treatment 2 Interventions

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.

Group II: Particulate Steroid Active Control 2 Interventions

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.

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

🇺🇸 Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

🇨🇦 Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

🇯🇵 Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of New Mexico Hospital Albuquerque, NM

Who Is Running the Clinical Trial?

University of New Mexico Lead Sponsor

References

1. France pubmed.ncbi.nlm.nih.gov

[Corticosteroid injections of the sacroiliac joint during magnetic resonance: preliminary results]. [2013] The aim of this study was to evaluate the advantages of MRguided injections of corticosteroids into the sacroiliac joints (SIJ) in patients suffering from refractory sacroiliitis despite appropriate oral therapy.

2. United States pubmed.ncbi.nlm.nih.gov

Management of diskogenic pain using epidural and intrathecal steroids. [2019] The use of methylprednisolone acetate (Depo-Medrol) injected by the epidural or intrathecal route for the relief of diskogenic back pain with or without radiculopathy is an adjunct to conservative management useful when conservative measures fail and surgical treatment is under consideration. This is especially true when symptoms have been present for only a few months. Corticosteroids injected in the same manner seem to have little effect on patients with symptoms persisting for periods longer than 3 months or in patients treated previously by surgical methods.

3. Italy pubmed.ncbi.nlm.nih.gov

Periarticular corticosteroid treatment of the sacroiliac joint in patients with seronegative spondylarthropathy. [2022] To evaluate the efficacy of periarticular corticosteroid injection of the sacroiliac joint (SIJ) in patients with seronegative spondylarthropathy in a double blind, controlled study.

4. France pubmed.ncbi.nlm.nih.gov

[Cortisone injection into the sacroiliac joint]. [2017] Corticosteroid injection of the sacroiliac joint can be proposed in inflammatory, or less frequently, in degenerative sacroiliac arthropathies. Significant pain relief is not only rapid and lasting, but also frequent (about 80% in seronegative spondylarthropathy).

5. Poland pubmed.ncbi.nlm.nih.gov

The impact of intra-sacroiliac joint methylprednisolone injection in the recovery of patients with spondyloarthropathy: a randomized controlled trial. [2022] Spondyloarthropathies are a group of chronic inflammatory diseases with specific clinical symptoms in rheumatic diseases. These patients suffer from pain in the joints. Physicians have tried several ways to decrease the pain in these patients. This study aimed to evaluate the effect of intra-sacroiliac joint methylprednisolone injection under the guidance of ultrasonography in spondyloarthropathy patients.

6. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of MR imaging guided steroid injection of the sacroiliac joints for the treatment of children with refractory enthesitis-related arthritis. [2021] To test the hypothesis that MR imaging guided triamcinolone acetonide injection into the sacroiliac joints of children with enthesitis-related arthritis is feasible, accurate and safe; and effectively reduces sacroiliac inflammation and disease progression.

7. Germany pubmed.ncbi.nlm.nih.gov

The chondrotoxicity of single-dose corticosteroids. [2021] Corticosteroids are commonly injected into the joint space. However, studies have not examined the chondrotoxicity of one-time injection doses. The purpose of this study is to evaluate the effect of dexamethasone sodium phosphate (Decadron), methylprednisolone acetate (Depo-Medrol), betamethasone sodium phosphate and betamethasone acetate (Celestone Soluspan), and triamcinolone acetonide (Kenalog) on human chondrocyte viability in vitro.

8. Germany pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging guided corticosteroid injection of sacroiliac joints in patients with spondylarthropathy. Are multiple injections more beneficial? [2018] Efficacy of a second magnetic resonance (MR) imaging guided corticosteroid injection of inflamed sacroiliac joints (SIJ) in patients with spondylarthropathy. Thirty-one patients received 50 injections in an outpatient basis. Fifteen of 31 patients who relapsed or were non-responders received a second injection. All had MR guided injection of 40 mg triamcinolone acetonide into SIJ using an open 0.2 Tesla unit. Twenty of 31 patients after the first injection, and 9 of 15 patients after the second injection reported subjective improvement, which lasted for a mean of 8.7+/-10.9 and 16.1+/-15.8 months for each group. Subchondral bone marrow edema resolved in 15 of 20 patients who reported subjective improvement, after the first injection. No complications occurred. MR guided steroid injection of SIJ is effective and safe. Since there is no exposure to radiation it could be performed many times. Repeated injections seem to be beneficial for primary non-responders and patients who relapsed.

9. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Intra-articular Sacroiliac Glucocorticoid Injections in Ankylosing Spondylitis. [2023] To assess the efficacy and safety of intra-articular sacroiliac glucocorticoid injection in ankylosing spondylitis (AS).

10. Canada pubmed.ncbi.nlm.nih.gov

Computed tomography guided corticosteroid injection of the sacroiliac joint in patients with spondyloarthropathy with sacroiliitis: clinical outcome and followup by dynamic magnetic resonance imaging. [2022] To evaluate computed tomography (CT) guided corticosteroid injections of inflamed sacroiliac (SI) joints in patients with spondyloarthropathies (SpA), and to evaluate dynamic magnetic resonance imaging (DMRI) of the SI joints in serial examinations of these patients, who had different degrees of inflammatory back pain.