Status:
RECRUITING
Conventional vs Bipolar SIJ RFA for Treatment of Sacroiliac Joint Pain
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Stratus Medical, INC
Conditions:
Sacroiliac Joint Complex
Low Back Pain
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
Specific Aims The sacroiliac joint complex (SIJC) is a diathrodial, synovial joint and posterior ligamentous network that receives both anterior innervation from the lumbosacral plexus as well as post...
Detailed Description
Low back pain affects the majority of individuals at some time in their lives. The estimated point prevalence of low back pain in 2015 was 7.3%, indicating that 540 million may be affected at any give...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT05409443
Start Date
August 15 2022
End Date
June 30 2027
Last Update
May 14 2024
Active Locations (3)
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1
University of Utah Farmington Health Center
Farmington, Utah, United States, 84025
2
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States, 84108
3
University of Utah South Jordan Health Center
South Jordan, Utah, United States, 84009