NCT05409443

Conventional vs Bipolar SIJ RFA for Treatment of Sacroiliac Joint Pain

Recruiting now Phase 4 Last updated 14 May 2024

What this trial tests

Phase 4 trial testing Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA) in Sacroiliac Joint Complex in 116 participants. Currently enrolling.

Timeline

15 August 2022

Primary endpoint
30 August 2026

30 June 2027

Quick facts

Lead sponsor	University of Utah
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	116
Start date	15 August 2022
Primary completion	30 August 2026
Estimated completion	30 June 2027
Sites	3 locations across United States

Drugs / interventions tested

• Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
• Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)

Conditions studied

• Sacroiliac Joint Complex — all drugs for Sacroiliac Joint Complex →
• Low Back Pain — all drugs for Low Back Pain →

Sponsor

University of Utah

Who can join

Adults 18 to 90, any sex, with Sacroiliac Joint Complex or Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 posterior sensory innervation via the posterior sacral network (PSN). The PSN is comprised by the lateral branches S1-S3 posterior rami, with variable contributions from S4 lateral branch, L4 medial branch, and L5 dorsal ramus. Pain signals originating from the SIJC can be interrupted with image-guided percutaneous radiofrequency ablation (RFA) of the PSN, thereby reducing pain and disability in carefully selected patients.

A prior systematic review estimated that 32-89% of patients achieve at least 50% pain relief for six months after some type of PSN ablation. Many experts suspect that heterogenous RFA techniques and technology are responsible for the variable success rates seen across published studies. Cadaveric work suggests that targeting the PSN with a large bipolar strip lesions would result in \>95% PSN neural capture compared to a smaller lesion produced by a conventional, monopolar, periforaminal RFA technique which may capture as low as 2.5% of the PSN. Nimbus is a commonly used multi-tined RFA probe whose large bipolar lesion size make it an ideal option for complete PSN neural ablation. Both the Nimbus (N-SIJRFA) and conventional (C-SIJRFA) techniques and technologies are commonly used; however, there are no prospective RCT's comparing them, and the clinical significance remains unknown.

Problem: There are no randomized controlled trials comparing novel technologies like N-SIJRFA to C-SIJRFA.

Purpose: To compare pain and disability outcomes in patients with confirmed SIJC pain after randomization to either N-SIJRFA or C-SIJRFA.

Central Hypothesis: N-SIJRFA will be more effective in improving pain and function compared to patients treated with C-SIJRFA at 3, 6, 12, 18, and 24 months.

Specific Aims:

1. Compare the proportion of participants who report ≥50% relief of pain by Numeric Pain Rating Scale (NPRS) after N-SIJRFA versus C-SIJRFA.
2. Compare the proportion of participants who report ≥15-point ODI (Oswestry Disability Index) reduction after N-SIJRFA versus C-SIJRFA.
3. Compare the proportion of participants with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) defined by ≥0.03, after N-SIJRFA versus C-SIJRFA.
4. Compare the proportions of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale after N-SIJRFA versus C-SIJRFA.
5. Evaluate the differences in success rates for pain improvement, functional improvement and satisfaction in those experiencing ≥ 50%, ≥ 80%, and 100% pain relief after either prognostic PSN blocks or intra-articular (IA) sacroiliac joint (SIJ) injections.
6. Determine the effect of PSN ablation on reducing pain related sleep disturbance as measured by the Pain and Sleep Questionnaire (PSQ-3).
7. Compare procedural time requirements between those treated with N-SIJRFA versus C-SIJRFA.
8. Report adverse effects.
9. Report rates of subsequent interventional healthcare utilization including repeat N-SIJRFA versus C-SIJRFA, SIJ injection, and SIJ fusion.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.