Conventional vs Bipolar SIJ RFA for Treatment of Sacroiliac Joint Pain
NCT ID: NCT05409443
Last Updated: 2024-05-14
Study Results
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Basic Information
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RECRUITING
PHASE4
116 participants
INTERVENTIONAL
2022-08-15
2027-06-30
Brief Summary
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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.
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Detailed Description
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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 affect 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion.
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.
* 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.
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
C-SIJRFA - using conventional monopolar periforaminal technique
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
* 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.
Interventions
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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.
* 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.
Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
* 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
90 Years
ALL
No
Sponsors
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Stratus Medical, INC
UNKNOWN
University of Utah
OTHER
Responsible Party
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Aaron Conger
Principle Investigator; Assistant Professor
Locations
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University of Utah Farmington Health Center
Farmington, Utah, United States
University of Utah Orthopaedic Center
Salt Lake City, Utah, United States
University of Utah South Jordan Health Center
South Jordan, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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References
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GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148.
Roberts SL, Burnham RS, Ravichandiran K, Agur AM, Loh EY. Cadaveric study of sacroiliac joint innervation: implications for diagnostic blocks and radiofrequency ablation. Reg Anesth Pain Med. 2014 Nov-Dec;39(6):456-64. doi: 10.1097/AAP.0000000000000156.
SOLONEN KA. The sacroiliac joint in the light of anatomical, roentgenological and clinical studies. Acta Orthop Scand Suppl. 1957;27:1-127. No abstract available.
Bradley KC. The anatomy of backache. Aust N Z J Surg. 1974 Jul;44(3):227-32. doi: 10.1111/j.1445-2197.1974.tb04409.x. No abstract available.
Roberts SL, Stout A, Loh EY, Swain N, Dreyfuss P, Agur AM. Anatomical Comparison of Radiofrequency Ablation Techniques for Sacroiliac Joint Pain. Pain Med. 2018 Oct 1;19(10):1924-1943. doi: 10.1093/pm/pnx329.
Shih CL, Shen PC, Lu CC, Liu ZM, Tien YC, Huang PJ, Chou SH. A comparison of efficacy among different radiofrequency ablation techniques for the treatment of lumbar facet joint and sacroiliac joint pain: A systematic review and meta-analysis. Clin Neurol Neurosurg. 2020 Aug;195:105854. doi: 10.1016/j.clineuro.2020.105854. Epub 2020 Apr 19.
Sahoo RK, Das G, Pathak L, Dutta D, Roy C, Bhatia A. Cryoneurolysis of Innervation to Sacroiliac Joints: Technical Description and Initial Results-A Case Series. A A Pract. 2021 Mar 30;15(4):e01427. doi: 10.1213/XAA.0000000000001427.
Nouer Frederico T, Ferraro LHC, Lemos JD, Sakata RK. Chemical neurolysis of the lateral branches of the sacral dorsal rami for the treatment of chronic pain in the sacroiliac joint: Case report and description of the technique. Pain Pract. 2022 Jan;22(1):134-136. doi: 10.1111/papr.13046. Epub 2021 Jun 25. No abstract available.
Ibrahim R, Telfeian AE, Gohlke K, Decker O. Endoscopic Radiofrequency Treatment of the Sacroiliac Joint Complex for Low Back Pain: A Prospective Study with a 2-Year Follow-Up. Pain Physician. 2019 Mar;22(2):E111-E118.
Najafi A, Sartoretti E, Binkert CA. Sacroiliac Joint Ablation Using MR-HIFU. Cardiovasc Intervent Radiol. 2019 Sep;42(9):1363-1365. doi: 10.1007/s00270-019-02263-0. Epub 2019 Jun 11.
Bogduk N. Commentary on King W, Ahmed S, Baisden J, Patel N, MacVicar J, Kennedy DJ. Diagnosis of posterior sacroiliac complex pain: a systematic review with comprehensive analysis of the published data. Pain Med. 2015 Feb;16(2):222-4. doi: 10.1111/pme.12615. Epub 2014 Nov 5. No abstract available.
Cohen SP, Strassels SA, Kurihara C, Crooks MT, Erdek MA, Forsythe A, Marcuson M. Outcome predictors for sacroiliac joint (lateral branch) radiofrequency denervation. Reg Anesth Pain Med. 2009 May-Jun;34(3):206-14. doi: 10.1097/AAP.0b013e3181958f4b.
Tinnirello A, Barbieri S, Todeschini M, Marchesini M. Conventional (Simplicity III) and Cooled (SInergy) Radiofrequency for Sacroiliac Joint Denervation: One-Year Retrospective Study Comparing Two Devices. Pain Med. 2017 Sep 1;18(9):1731-1744. doi: 10.1093/pm/pnw333.
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Copay AG, Glassman SD, Subach BR, Berven S, Schuler TC, Carreon LY. Minimum clinically important difference in lumbar spine surgery patients: a choice of methods using the Oswestry Disability Index, Medical Outcomes Study questionnaire Short Form 36, and pain scales. Spine J. 2008 Nov-Dec;8(6):968-74. doi: 10.1016/j.spinee.2007.11.006. Epub 2008 Jan 16.
Soer R, Reneman MF, Speijer BL, Coppes MH, Vroomen PC. Clinimetric properties of the EuroQol-5D in patients with chronic low back pain. Spine J. 2012 Nov;12(11):1035-9. doi: 10.1016/j.spinee.2012.10.030.
Ayearst L, Harsanyi Z, Michalko KJ. The Pain and Sleep Questionnaire three-item index (PSQ-3): a reliable and valid measure of the impact of pain on sleep in chronic nonmalignant pain of various etiologies. Pain Res Manag. 2012 Jul-Aug;17(4):281-90. doi: 10.1155/2012/635967.
Tonosu J, Oka H, Watanabe K, Abe H, Higashikawa A, Kawai T, Yamada K, Nakarai H, Tanaka S, Matsudaira K. Characteristics of the spinopelvic parameters of patients with sacroiliac joint pain. Sci Rep. 2021 Mar 4;11(1):5189. doi: 10.1038/s41598-021-84737-1.
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Other Identifiers
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IRB 150067
Identifier Type: -
Identifier Source: org_study_id
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