Conventional vs Bipolar SIJ RFA for Treatment of Sacroiliac Joint Pain

NCT05409443 | Recruiting Phase 4

• 1 other identifier: IRB 150067
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 3

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, 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. 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. 2.Compare the proportion of participants who report ≥15-point ODI (Oswestry Disability Index) reduction after N-SIJRFA versus C-SIJRFA.
3. 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. 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. 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. 6.Determine the effect of PSN ablation on reducing pain related sleep disturbance as measured by the Pain and Sleep Questionnaire (PSQ-3).
7. 7.Compare procedural time requirements between those treated with N-SIJRFA versus C-SIJRFA.
8. 8.Report adverse effects.
9. 9.Report rates of subsequent interventional healthcare utilization including repeat N-SIJRFA versus C-SIJRFA, SIJ injection, and SIJ fusion.

Conditions

Sacroiliac Joint Complex; Low Back Pain

Keywords

Sacroiliac Joint

Outcome Measures

Primary Outcomes (1)

• Change in Percent in NPRS Pain Score

  The proportion of participants with ≥50% change in NPRS pain score at the 3-month follow-up assessment.

  3 month

Secondary Outcomes (19)

• Percent of Relief

  6 month

• Percent of Relief

  12 month

• Percent of Relief

  18 month

• Percent of Relief

  24 month

• ODI Reduction

  3 month

Study Arms (2)

Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)

ACTIVE COMPARATOR

N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.

Procedure: Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)

Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)

ACTIVE COMPARATOR

C-SIJRFA - using conventional monopolar periforaminal technique

Procedure: Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)

Interventions

Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA) PROCEDURE

* 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. * The appropriate locations are confirmed in both AP and lateral views and the tines are deployed. Following injection of 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.

Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)

Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA) PROCEDURE

* To target the L4 medial branch and L5 dorsal ramus, an electrode will be placed in parallel between the junction of the L5 transverse process and superior articular process and the sacral ala and S1 superior articular process. * A periforaminal electrode position will be used to target the lateral branches from S1 to S3. An 22-G cannula with a 5-mm exposed tip will be 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 lidocaine, monopolar RFA is performed for 90 seconds at 80 degrees Celsius at each location.

Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• Stratus Medical, INC: collaborator

Study Sites (3)

University of Utah Farmington Health Center

Farmington, Utah, 84025, United States

RECRUITING

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

RECRUITING

University of Utah South Jordan Health Center

South Jordan, Utah, 84009, United States

RECRUITING

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MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

PMR Research Group

CONTACT

801-587-5488; PMR.Research@hsc.utah.edu

Aaron Conger, DO

CONTACT

801-587-5488; aaron.conger@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator; Assistant Professor

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

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 8, 2022
• Study Start: August 15, 2022
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)