Comparing two methods for treating sacroiliac joint pain
Conventional or Bipolar Radiofrequency Ablation for the Treatment of Sacroiliac Joint Pain? The COBRA-SIJ Study, a Double-blinded, Randomized, Comparative Trial.
This study is testing two different radiofrequency techniques to see which one works better for relieving sacroiliac joint pain in adults who have had low back pain for at least three months.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Locations | 3 sites (Farmington, Utah and 2 other locations) |
| Trial ID | NCT05409443 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two different radiofrequency ablation techniques for treating pain originating from the sacroiliac joint complex. Participants will be adults aged 18-90 who have experienced low back pain for at least three months and have not found relief from conservative treatments. The study will evaluate pain relief outcomes using image-guided percutaneous radiofrequency ablation targeting the posterior sacral network. By analyzing the success rates of conventional versus bipolar techniques, the trial seeks to identify the most effective approach for alleviating pain and improving quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-90 with chronic low back pain who have not responded to conservative treatments.
Not a fit: Patients with a history of sacroiliac joint fusion or prior radiofrequency ablation procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective treatment option for chronic sacroiliac joint pain.
How similar studies have performed: Previous studies have shown variable success rates with different radiofrequency ablation techniques, indicating that this comparative approach is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult participants aged 18-90 years old with at least 3 months of low back pain who have not responded to at least 3 months of conservative treatment. * 7-day average NPRS for low back pain of at least 4/10 at baseline * Pain relieved by at least 50% by either a fluoroscopically-guided intraarticular sacroiliac joint injection including a local anesthetic and a fluoroscopically-guided PSN block or dual fluoroscopically-guided PSN blocks. * Participants capable of understanding and providing consent in English and capable of complying with the outcome instruments used. A pain diary with appropriate diagnostic categories of relief (100% relief, 80-99% relief, etc.), will be provided. Duration of pain relief will not be used as it has been shown to only marginally improve diagnostic confidence (17). Exclusion Criteria: * History of SIJ fusion. * Prior SIJ RFA procedure * Symptomatic hip osteoarthritis * Active lumbar radicular pain * Evidence of hardware loosening (in participants with history lumbar or lumbosacral fusion). * Presence of pacemaker or neurostimulator. * Chronic widespread pain or somatoform disorder (e.g., fibromyalgia). * More than 50 mg morphine-equivalent per day opioid use. * Active bacterial infection or treatment of infection with antibiotics within the past 4 weeks. * Medical conditions causing significant functional disability (e.g., stroke, COPD). * Addictive behavior, severe clinical depression, or psychotic features. * History of anaphylactic reaction to any medication used. * Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation). * Those involved in active litigation relevant to their pain. * The participant is incarcerated.
Where this trial is running
Farmington, Utah and 2 other locations
- University of Utah Farmington Health Center — Farmington, Utah, United States (Recruiting)
- University of Utah Orthopaedic Center — Salt Lake City, Utah, United States (Recruiting)
- University of Utah South Jordan Health Center — South Jordan, Utah, United States (Recruiting)
Study contacts
- Study coordinator: PMR Research Group
- Email: PMR.Research@hsc.utah.edu
- Phone: 801-587-5488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.