Steroid Injections for Sacroiliac Joint Dysfunction

Overseen By Mark W Shilling, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of New Mexico

Disqualifiers: Systemic inflammatory arthritis, Chronic widespread pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Immediate

230 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two steroid injections to determine which better relieves pain in the sacroiliac (SI) joint, connecting the spine to the pelvis. The study compares dexamethasone and methylprednisolone injections to identify which provides more effective pain relief. Individuals with ongoing lower back or buttock pain for at least two weeks and diagnosed with SI joint pain might be suitable candidates. Participants should have experienced significant pain relief shortly after a previous SI joint injection. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.

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 is the safety track record for these treatments?

Research shows that steroid injections for sacroiliac joint pain are generally safe. Studies have found no complications in patients receiving MRI-guided steroid injections. Specifically, dexamethasone is well-tolerated, with no major safety concerns reported.

Research also supports the safety of methylprednisolone. Commonly used for joint injections, it provides pain relief without significant side effects, though it can cause minor effects like temporary increases in blood sugar levels.

Both dexamethasone and methylprednisolone have been used safely for sacroiliac joint injections in most patients. This trial aims to compare these two to determine which one might be more effective at relieving pain. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for sacroiliac joint dysfunction, which often involve oral pain medications or physical therapy, this trial is exploring the effectiveness of steroid injections with two different formulations. Researchers are excited because these injections use dexamethasone and methylprednisolone, which are potent anti-inflammatory steroids that can be directly administered to the affected joint. This direct delivery method allows for potentially faster and more targeted relief compared to systemic treatments. Additionally, the trial compares non-particulate dexamethasone against particulate methylprednisolone, which could reveal differences in how these steroids act in the body, offering insights into optimizing injection therapies for better outcomes.

What evidence suggests that this trial's treatments could be effective for SI joint pain?

This trial will compare the effectiveness of dexamethasone and methylprednisolone for treating sacroiliac (SI) joint dysfunction. Research has shown that both dexamethasone, administered to participants in one trial arm, and methylprednisolone, given to participants in another arm, can effectively treat SI joint pain. Specifically, one study found that dexamethasone significantly reduced pain, with 85% of patients experiencing relief within four weeks after injection. Methylprednisolone also provides strong pain relief when injected into the SI joint, especially with guided techniques. Both treatments have proven effective in managing SI joint problems and reducing pain. This evidence suggests that both steroids are viable options for treating pain related to SI joint issues. ^{1 3 6 7 8}

Who Is on the Research Team?

Reza Ehsanian, MD, PhD

Principal Investigator

University of New Mexico Department of Anesthesiology and Critical Care

Are You a Good Fit for This Trial?

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

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.

I have had pain in my lower back or buttocks for at least 2 weeks.

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Methylprednisolone

Trial Overview

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

Published Research Related to This Trial

In a study evaluating the effects of various corticosteroids on human chondrocyte viability, betamethasone sodium phosphate and betamethasone acetate were found to significantly decrease chondrocyte viability after a single injection, indicating potential chondrotoxicity.

Triamcinolone acetonide also showed signs of chondrotoxicity, but only in one trial, while betamethasone consistently caused significant cell death over a 14-day period, suggesting it should be used with caution in joint injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The chondrotoxicity of single-dose corticosteroids. Dragoo, JL., Danial, CM., Braun, HJ., et al.[2021]

In a double-blind study involving 20 patients with seronegative spondylarthropathy, periarticular corticosteroid injection of methylprednisolone significantly reduced pain in the sacroiliac joint compared to a placebo after two months.

Patients receiving the methylprednisolone injection showed notable improvements in pain assessment scores, indicating that this treatment may be effective for managing clinical sacroiliitis in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periarticular corticosteroid treatment of the sacroiliac joint in patients with seronegative spondylarthropathy. Luukkainen, R., Nissilä, M., Asikainen, E., et al.[2022]

Intra-articular sacroiliac glucocorticoid injections significantly reduced pain and inflammation in 96 patients with ankylosing spondylitis, as evidenced by improvements in pain scores and inflammatory markers like ESR and CRP after treatment.

The treatment was found to be safe, with no serious adverse events reported, making it a viable option for managing active sacroiliitis in ankylosing spondylitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Intra-articular Sacroiliac Glucocorticoid Injections in Ankylosing Spondylitis. Nam, B., Kim, TH., Lee, SW., et al.[2023]

Methylprednisolone acetate (Depo-Medrol) injections via epidural or intrathecal routes can effectively relieve diskogenic back pain and radiculopathy when conservative treatments have failed, particularly if symptoms have lasted less than three months.

Corticosteroid injections are less effective for patients with chronic symptoms lasting over three months or those who have previously undergone surgery, suggesting a limited window for optimal use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of diskogenic pain using epidural and intrathecal steroids. Brown, FW.[2019]

In a study involving 31 patients with spondylarthropathy, MR-guided corticosteroid injections into inflamed sacroiliac joints were found to be effective and safe, with no complications reported.

A second injection was beneficial for patients who did not respond to the first treatment, with 9 out of 15 showing improvement lasting an average of 16.1 months, indicating that repeated injections can provide additional relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging guided corticosteroid injection of sacroiliac joints in patients with spondylarthropathy. Are multiple injections more beneficial? Günaydin, I., Pereira, PL., Fritz, J., et al.[2018]

In a study of 60 patients with spondyloarthropathy, intra-sacroiliac joint injections of methylprednisolone significantly reduced pain and improved function as measured by the Visual Analogue Scale (VAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) within 2 weeks and maintained these benefits for up to 8 weeks.

The use of ultrasound guidance for the injection not only enhanced the effectiveness of the treatment but also ensured safety by avoiding radiation exposure, making it a promising option for managing pain in spondyloarthropathy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of intra-sacroiliac joint methylprednisolone injection in the recovery of patients with spondyloarthropathy: a randomized controlled trial. Rajaei, E., Bavieh, K., Mowla, K., et al.[2022]

Corticosteroid injections into the sacroiliac joint can provide significant and rapid pain relief for patients with inflammatory conditions, such as seronegative spondylarthropathy, with about 80% of patients experiencing relief.

This treatment is also applicable for degenerative sacroiliac arthropathies, highlighting its versatility in managing different types of joint pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cortisone injection into the sacroiliac joint]. Bellaïche, L.[2017]

In a study involving 12 patients with persistent buttock pain due to sacroiliitis, MR-guided corticosteroid injections into the sacroiliac joints led to significant clinical improvement, with a mean pain-free period of 9.6 months.

The dolorimetry scale showed a reduction in pain from an average of 7.6 to 2.9 after three months, allowing some patients to discontinue or reduce their use of nonsteroidal anti-inflammatory drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Corticosteroid injections of the sacroiliac joint during magnetic resonance: preliminary results]. Pereira, PL., Günaydin, I., Duda, SH., et al.[2013]

In a study of 14 children with enthesitis-related arthritis, MR imaging guided injections of triamcinolone acetonide into the sacroiliac joints were found to be safe and effective, with a 79% success rate in reducing inflammation.

The procedure significantly decreased sacroiliac inflammation by 59%, with a median remission time of 13.7 months and no complications or erosions reported, suggesting it may help prevent disease progression.

NCBI (Pubmed)

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. Fritz, J., Tzaribachev, N., Thomas, C., et al.[2021]

CT-guided corticosteroid injections significantly improved inflammatory back pain and sacroiliitis in 83.3% of the 30 patients with spondyloarthropathies, with pain relief lasting an average of 8.9 months.

Dynamic magnetic resonance imaging (DMRI) effectively quantified inflammation in the sacroiliac joints, providing a useful tool for assessing treatment response over time.

NCBI (Pubmed)

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. Braun, J., Bollow, M., Seyrekbasan, F., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9090203/

Efficacy of Sacroiliac Joint Injection With Anesthetic and ...

Following the SIJ injection, pain relief was observed at each of the three visits - 85% (n=23) experienced pain relief at four weeks, 81% (n=22) ...

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painphysicianjournal.com

painphysicianjournal.com/current/pdf?article=NzcxNQ%3D%3D&journal=154

Therapeutic Sacroiliac Joint Injections Effectiveness Review

Overall, the qualitative and quantitative evidence combined shows Level III or fair evidence for therapeutic sacroiliac joint injections for ...

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Comparative Efficacy of Clinical Interventions for Sacroiliac ...

We aimed to identify the most effective clinical treatment method for sacroiliac joint (SIJ)-related pain based on the systematic review and ...

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Dexamethasone Effectively Reduces the Incidence of Post- ...

Results: At the time of data analysis, 35/63 patients completed the study protocol. There was a statistically significant reduction in the ...

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Minimally Invasive and Conservative Interventions for the ...

The effectiveness of SIJ injection treatment, especially in the long term, is decreased in patients with high-grade arthritis. Good outcomes ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06268704

Particulate Vs. Non-Particulate Steroid for Sacroiliac Joint ...

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

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withpower.com

withpower.com/trial/phase-4-sacroiliac-joint-dysfunction-2-2024-6019a

Steroid Injections for Sacroiliac Joint Dysfunction

Research indicates that MR-guided steroid injections into the sacroiliac joints are generally safe, with no complications reported in studies involving patients ...

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Diagnosis and Non-Surgical Treatment of Sacroiliac Joint Pain

For individuals who have SIJ pain who receive therapeutic corticosteroid injections, the evidence includes systematic reviews, randomized controlled trials ( ...