Conventional or Bipolar SIJ RFA

Sponsor

University of Utah (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05409443

Collaborator

Stratus Medical, INC (Other)

116

Enrollment

Arms

46.5

Anticipated Duration (Months)

Study Details

Study Description

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 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 and the 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: The 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:

Compare the proportion of participants who report ≥50% relief of pain by Numeric Pain Rating Scale (NPRS) after N-SIJRFA versus C-SIJRFA.

Condition or Disease	Intervention/Treatment	Phase
Sacroiliac Joint Complex Low Back Pain	Procedure: Sacroiliac Joint Radiofrequency Ablation	Phase 4

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 given time (1). The etiology of low back pain may be multifactorial but commonly is often attributed to nociception arising sacroiliac joint complex (SIJC) in as many as 15-30% of patients (2). The SIJC is a diathrodial, synovial joint that receives both anterior innervation from the lumbosacral plexus as well as posterior sensory innervation via the posterior sacral network (PSN) (3). The PSN is comprised by the lateral branches S1-S3 posterior rami, with variable contributions from S4 lateral branch and the L5 dorsal ramus (3-6). These have been targeted for neurotomy most commonly with image-guided percutaneous radiofrequency ablation (RFA) (7), but also with percutaneous cryoneurolysis (8), chemical neurolysis (9), endoscopic-guided RFA (10), and MRI high frequency ultrasound treatment (MRI-HIFU) (11).

Prior systematic review has suggested that 32-89% of patients may achieve at least 50% pain relief for six months, while 11-44% of patients achieved 100% pain relief for the same period (12). Although elements of patient selection likely effect this estimate (13), studies have used a variety of different RFA techniques to target the PSN which also may impact success rates. Few studies have directly compared these techniques, but cadaveric work has suggested that targeting the PSN with bipolar strip lesions results in substantially higher rates of neural capture compared to periforaminal RFA performed with conventional monopolar electrodes (6). Further, the rate of complete neural capture with a periforaminal conventional monopolar RFA may be as low as 12.5%, which is perhaps one reason why some clinical studies have shown increased probability of success in groups treated with technologies known to create larger lesions (13,14). Similar effectiveness has been observed for periforaminal techniques with both conventional monopolar compared to larger cooled monopolar lesions (15), as well as between large continuous-lesion multi-electrode lesioning compared to periforaminal conventional monopolar technique (16). However, no study has directly compared a bipolar strip lesion using a "palisade" technique (N-SIJRFA) to a conventional monopolar periforaminal method, the latter of which is used commonly in many practice settings.

The primary purpose of the current study is to evaluate the effectiveness of RFA of the PSN using a bipolar "palisade" technique to create a continuous strip lesion compared to conventional monopolar periforaminal technique in the treatment of patients with sacroiliac joint complex pain. Given the findings of recent cadaveric studies, the results of the proposed work may substantially impact the current treatment paradigm for PSN neurotomy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Participants will be blinded to the group to which they are randomized. Given inherent approach differences between techniques, the physician performing the procedure cannot be blinded. However, staff responsible for outcome collection will remain blinded.

Primary Purpose:

Treatment

Official Title:

Conventional or Bipolar Radiofrequency Ablation for the Treatment of Sacroiliac Joint Pain? The COBRA-SIJ Study, a Double-blinded, Randomized, Comparative Trial.

Anticipated Study Start Date :

Aug 15, 2022

Anticipated Primary Completion Date :

Aug 30, 2025

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA) Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2, and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm (3,6). The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of 1mL 2% lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation the tines are retracted for all electrodes prior to removal.	Procedure: Sacroiliac Joint Radiofrequency Ablation Sacroiliac Joint Radiofrequency Ablation are performed using fluoroscopic guidance for accuracy of needle placement. Participant will be positioned by the physician and procedure staff on a fluoroscopic table. Blood pressure and pulse oximetry monitors will be placed. A pre-procedure time-out will be performed, as is protocol for all spinal injection procedures. No sedation or post-procedural corticosteroid will be used during these procedures, only local anesthetic (lidocaine). The skin and superficial tissues will be anesthetized at each site with 1-2 mL of 1% lidocaine. Prior to the ablation up to 2 mL of 2% lidocaine may be used at each site to ensure adequate pain control during the ablation. Once in position, a radiofrequency ablation lesion will be made using a 30 second ramp-up time to a maximum temperature of 80 °C, followed by an additional 90 seconds at maximum temperature.
Active Comparator: Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA) To target the L5 dorsal ramus, an electrode will be placed in parallel between the junction of the sacral ala and S1 superior articular process. A periforaminal electrode position will be used to target the lateral branches from S1 to S3, as suggested by Roberts et al. and previously performed by Cohen et al. (6,18). An 22-G cannula with a 5-mm exposed tip was directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18). The appropriate locations are confirmed in both AP and lateral views. Following injection of 1mL 2% lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.	Procedure: Sacroiliac Joint Radiofrequency Ablation Sacroiliac Joint Radiofrequency Ablation are performed using fluoroscopic guidance for accuracy of needle placement. Participant will be positioned by the physician and procedure staff on a fluoroscopic table. Blood pressure and pulse oximetry monitors will be placed. A pre-procedure time-out will be performed, as is protocol for all spinal injection procedures. No sedation or post-procedural corticosteroid will be used during these procedures, only local anesthetic (lidocaine). The skin and superficial tissues will be anesthetized at each site with 1-2 mL of 1% lidocaine. Prior to the ablation up to 2 mL of 2% lidocaine may be used at each site to ensure adequate pain control during the ablation. Once in position, a radiofrequency ablation lesion will be made using a 30 second ramp-up time to a maximum temperature of 80 °C, followed by an additional 90 seconds at maximum temperature.

Arm

Intervention/Treatment

Active Comparator: Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)

Electrodes are positioned along the lateral sacral crest lateral to the inflection points of the S1, S2, and S3 lateral foraminal walls along first to third transverse sacral tubercles maintaining a craniocaudal line with an interelectrode distance of no more than 15mm (3,6). The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of 1mL 2% lidocaine, lesions are performed at 85 degrees Celsius for 180 seconds at each site for bipolar sites and 80 degrees Celsius for 90 seconds for the monopolar site. Following ablation the tines are retracted for all electrodes prior to removal.

Procedure: Sacroiliac Joint Radiofrequency Ablation

Sacroiliac Joint Radiofrequency Ablation are performed using fluoroscopic guidance for accuracy of needle placement. Participant will be positioned by the physician and procedure staff on a fluoroscopic table. Blood pressure and pulse oximetry monitors will be placed. A pre-procedure time-out will be performed, as is protocol for all spinal injection procedures. No sedation or post-procedural corticosteroid will be used during these procedures, only local anesthetic (lidocaine). The skin and superficial tissues will be anesthetized at each site with 1-2 mL of 1% lidocaine. Prior to the ablation up to 2 mL of 2% lidocaine may be used at each site to ensure adequate pain control during the ablation. Once in position, a radiofrequency ablation lesion will be made using a 30 second ramp-up time to a maximum temperature of 80 °C, followed by an additional 90 seconds at maximum temperature.

Active Comparator: Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)

To target the L5 dorsal ramus, an electrode will be placed in parallel between the junction of the sacral ala and S1 superior articular process. A periforaminal electrode position will be used to target the lateral branches from S1 to S3, as suggested by Roberts et al. and previously performed by Cohen et al. (6,18). An 22-G cannula with a 5-mm exposed tip was directed to a location approximately 3-5mm lateral to the PSFA of S1, S2, and S3. The "analog clock" positions for the probes at S1 and S2 levels will be 1:00, 3:00, and 5:30 on the right, and 6:30, 9:00, and 11:00 on the left. For the S3 level the positions at 1:30 and 4:30 on the right, and 7:30 and 10:30 on the left will be used (6,18). The appropriate locations are confirmed in both AP and lateral views. Following injection of 1mL 2% lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.

Procedure: Sacroiliac Joint Radiofrequency Ablation

Outcome Measures

Primary Outcome Measures

Reduction Percent in NPRS Pain Score [3 month]
The proportion of participants with ≥50% reduction in NPRS pain score at the 3-month follow-up assessment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Utah
Stratus Medical, INC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Aaron Conger, Principle Investigator; Assistant Professor, University of Utah

ClinicalTrials.gov Identifier:

NCT05409443

Other Study ID Numbers:

SIJ RFA

First Posted:

Jun 8, 2022

Last Update Posted:

Jul 29, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Aaron Conger, Principle Investigator; Assistant Professor, University of Utah

Sacroiliac Joint

Additional relevant MeSH terms:

Low Back Pain

Study Results

No Results Posted as of Jul 29, 2022