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Due to insurance changes for SIJ RFAs, enrollment was slow. The sponsor decided to end the study.
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| Name | Class |
|---|---|
| Stratus Medical, INC | UNKNOWN |
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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:
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, L4 medial branch, and 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA) | Active Comparator | N-SIJRFA - using a bipolar "palisade" technique to create a continuous strip lesion. |
|
| Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA) | Active Comparator | C-SIJRFA - using conventional monopolar periforaminal technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA) | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Numeric Pain Rating Score | The number of participants with ≥50% change in their Numeric Pain Rating Scale (NPRS) pain score at the 3-month follow-up assessment. The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain. | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Relief Using the Numeric Pain Rating Scale | The number of participants with ≥50%, relief of pain by the Numeric Pain Rating Scale (NPRS) The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain. | 6 month |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Farmington Health Center | Farmington | Utah | 84025 | United States | ||
| University of Utah Orthopaedic Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27733282 | Background | 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. | |
| 23253394 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2024 |
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To compare pain and disability outcomes in patients with confirmed SIJC pain after randomization to either N-SIJRFA or C-SIJRFA.
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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.
|
| Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA) | Procedure |
|
|
| Percent of Relief Using the Numeric Pain Rating Scale | The number of participants with ≥50%, relief of pain by the Numeric Pain Rating Scale The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain. | 12 month |
| Percent of Relief Using the Numeric Pain Rating Scale | The percentage of participants with ≥50%, relief of pain by Numeric Pain Rating Scale The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain. | 18 month |
| Percent of Relief Using the Numeric Pain Rating Scale. NOTE: The Study Ended Before Month 24 Data Could be Gathered. | The number of participants with ≥50%, relief of pain by Numeric Pain Rating Scale The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain. | 24 month |
| Oswestry Disability Index (ODI) Reduction | The number of participants who report ≥15-point ODI reduction. The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel.
Interpretation of ODI Scores:
| 3 month |
| Oswestry Disability Index (ODI) Reduction | The number of participants who report ≥15-point ODI reduction. The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel.
Interpretation of ODI Scores:
| 6 month |
| Oswestry Disability Index (ODI) Reduction | The number of participants who report ≥15-point ODI reduction The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel.
Interpretation of ODI Scores:
| 12 month |
| Oswestry Disability Index (ODI) Reduction | The number of participants who report ≥15-point ODI reduction The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel.
Interpretation of ODI Scores:
| 18 month |
| Oswestry Disability Index (ODI) Reduction NOTE: The Study Ended Before Month 24 Data Could be Gathered. | The number of participants who report ≥15-point ODI reduction The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel. NOTE: The study ended before month 24 data could be gathered.
Interpretation of ODI Scores:
| 24 month |
| EQ-5D Improvement | The number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments | 3 month |
| EQ-5D Improvement | The number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments | 6 month |
| EQ-5D Improvement | The number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments | 12 month |
| EQ-5D Improvement | The number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments | 18 month |
| EQ-5D Improvement | The proportion of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments | 24 month |
| Patient Global Impression of Change (PGIC) Improvement | The number of participants who report being "improved" or "much improved" on the PGIC scale | 3 month |
| PGIC Improvement | The number of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale | 6 month |
| PGIC Improvement | The number of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale | 12 month |
| PGIC Improvement | The number of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale | 18 month |
| PGIC Improvement NOTE: The Study Ended Before Month 24 Data Could be Gathered. | The proportions of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale | 24 month |
| The Pain and Sleep Questionnaire Three-item Index (PSQ-3) | The number of participants who had improvement in pain-related sleep disturbance as measured by the PSQ-3. This index measures the impact of pain on sleep in chronic pain using 3 questions:
There are six answers participants will choose from for each question with a corresponding score: Always=1, Very Frequently = 2, Occasionally = 3, Rarely = 4, Very Rarely = 5 and Never = 6. A high score indicates that the participant's back pain is not interfering with their sleep. Lower scores mean the participant's back pain is interfering with their sleep. | 3 Months |
| The Pain and Sleep Questionnaire Three-Item Index (PSQ-3) | The number of participants who had improvement in pain-related sleep disturbance as measured by the PSQ-3. This index measures the impact of pain on sleep in chronic pain using 3 questions:
There are six answers participants will choose from for each question with a corresponding score: Always=1, Very Frequently = 2, Occasionally = 3, Rarely = 4, Very Rarely = 5 and Never = 6. A high score indicates that the participant's back pain is not interfering with their sleep. Lower scores mean the participant's back pain is interfering with their sleep. | 6 Months |
| The Pain and Sleep Questionnaire Three-Item Index (PSQ-3) | The number of participants who had improvement in pain-related sleep disturbance as measured by the PSQ-3. This index measures the impact of pain on sleep in chronic pain using 3 questions:
There are six answers participants will choose from for each question with a corresponding score: Always=1, Very Frequently = 2, Occasionally = 3, Rarely = 4, Very Rarely = 5 and Never = 6. A high score indicates that the participant's back pain is not interfering with their sleep. Lower scores mean the participant's back pain is interfering with their sleep. | 12 Months |
| The Pain and Sleep Questionnaire Three-Item Index (PSQ-3) | The number of participants who had improvement in pain-related sleep disturbance as measured by the PSQ-3. This index measures the impact of pain on sleep in chronic pain using 3 questions:
There are six answers participants will choose from for each question with a corresponding score: Always=1, Very Frequently = 2, Occasionally = 3, Rarely = 4, Very Rarely = 5 and Never = 6. A high score indicates that the participant's back pain is not interfering with their sleep. Lower scores mean the participant's back pain is interfering with their sleep. | 18 Months |
| Salt Lake City |
| Utah |
| 84108 |
| United States |
| University of Utah South Jordan Health Center | South Jordan | Utah | 84009 | United States |
| 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. |
| 25304483 | Background | 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. |
| 13478452 | Background | 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. |
| 4282245 | Background | 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. |
| 29415262 | Background | 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. |
| 32353665 | Background | 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. |
| 33783380 | Background | 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. |
| 34077624 | Background | 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. |
| 30921988 | Background | 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. |
| 31187230 | Background | 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. |
| 25371349 | Background | 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. |
| 19587617 | Background | 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. |
| 28340063 | Background | 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. |
| 22688606 | Background | Cheng J, Pope JE, Dalton JE, Cheng O, Bensitel A. Comparative outcomes of cooled versus traditional radiofrequency ablation of the lateral branches for sacroiliac joint pain. Clin J Pain. 2013 Feb;29(2):132-7. doi: 10.1097/AJP.0b013e3182490a17. |
| 31747020 | Background | Speldewinde GC. Successful Thermal Neurotomy of the Painful Sacroiliac Ligament/Joint Complex-A Comparison of Two Techniques. Pain Med. 2020 Mar 1;21(3):561-569. doi: 10.1093/pm/pnz282. |
| Background | Bogduk N. On the Rational Use of Diagnostic Blocks for Spinal Pain. Neurosurg Q. 2009 Jun;19(2):88-100. |
| 18648237 | Background | Cohen SP, Hurley RW, Buckenmaier CC 3rd, Kurihara C, Morlando B, Dragovich A. Randomized placebo-controlled study evaluating lateral branch radiofrequency denervation for sacroiliac joint pain. Anesthesiology. 2008 Aug;109(2):279-88. doi: 10.1097/ALN.0b013e31817f4c7c. |
| 18201937 | Background | 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. |
| 23199409 | Background | 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. |
| 22891194 | Background | 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. |
| 33664386 | Background | 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. |
| 30887220 | Background | Tonosu J, Kurosawa D, Nishi T, Ito K, Morimoto D, Musha Y, Ozawa H, Murakami E. The association between sacroiliac joint-related pain following lumbar spine surgery and spinopelvic parameters: a prospective multicenter study. Eur Spine J. 2019 Jul;28(7):1603-1609. doi: 10.1007/s00586-019-05952-z. Epub 2019 Mar 18. |
| FG001 | 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.
|
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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.
|
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Numeric Pain Rating Score | The number of participants with ≥50% change in their Numeric Pain Rating Scale (NPRS) pain score at the 3-month follow-up assessment. The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain. | Posted | Count of Participants | Participants | 3 month |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Percent of Relief Using the Numeric Pain Rating Scale | The number of participants with ≥50%, relief of pain by the Numeric Pain Rating Scale (NPRS) The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain. | Posted | Count of Participants | Participants | 6 month |
| ||||||||||||||||||||||||||||||||
| Secondary | Percent of Relief Using the Numeric Pain Rating Scale | The number of participants with ≥50%, relief of pain by the Numeric Pain Rating Scale The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain. | Posted | Count of Participants | Participants | 12 month |
| ||||||||||||||||||||||||||||||||
| Secondary | Percent of Relief Using the Numeric Pain Rating Scale | The percentage of participants with ≥50%, relief of pain by Numeric Pain Rating Scale The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain. | Posted | Count of Participants | Participants | 18 month |
| ||||||||||||||||||||||||||||||||
| Secondary | Percent of Relief Using the Numeric Pain Rating Scale. NOTE: The Study Ended Before Month 24 Data Could be Gathered. | The number of participants with ≥50%, relief of pain by Numeric Pain Rating Scale The NPRS is an 11-point numeric scale ranging from 0 to 10, with zero representing "No pain" and ten representing "worst imaginable pain" Using the numbering system, Participants indicate the number that best describes their pain. | Not Posted | 24 month | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Oswestry Disability Index (ODI) Reduction | The number of participants who report ≥15-point ODI reduction. The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel.
Interpretation of ODI Scores:
| Posted | Count of Participants | Participants | 3 month |
| ||||||||||||||||||||||||||||||||
| Secondary | Oswestry Disability Index (ODI) Reduction | The number of participants who report ≥15-point ODI reduction. The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel.
Interpretation of ODI Scores:
| Posted | Count of Participants | Participants | 6 month |
| ||||||||||||||||||||||||||||||||
| Secondary | Oswestry Disability Index (ODI) Reduction | The number of participants who report ≥15-point ODI reduction The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel.
Interpretation of ODI Scores:
| Posted | Count of Participants | Participants | 12 month |
| ||||||||||||||||||||||||||||||||
| Secondary | Oswestry Disability Index (ODI) Reduction | The number of participants who report ≥15-point ODI reduction The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel.
Interpretation of ODI Scores:
| Posted | Count of Participants | Participants | 18 month |
| ||||||||||||||||||||||||||||||||
| Secondary | Oswestry Disability Index (ODI) Reduction NOTE: The Study Ended Before Month 24 Data Could be Gathered. | The number of participants who report ≥15-point ODI reduction The Oswestry Disability Index (ODI) is a questionnaire used to measure the level of function and disability related to lower back pain. It consists of 10 questions that assess pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex, social life, and travel. NOTE: The study ended before month 24 data could be gathered.
Interpretation of ODI Scores:
| Not Posted | 24 month | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | EQ-5D Improvement | The number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments | Posted | Count of Participants | Participants | 3 month |
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| Secondary | EQ-5D Improvement | The number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments | Posted | Count of Participants | Participants | 6 month |
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| Secondary | EQ-5D Improvement | The number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments | Posted | Count of Participants | Participants | 12 month |
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| Secondary | EQ-5D Improvement | The number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments | Posted | Count of Participants | Participants | 18 month |
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| Secondary | EQ-5D Improvement | The proportion of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments | Not Posted | 24 month | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Patient Global Impression of Change (PGIC) Improvement | The number of participants who report being "improved" or "much improved" on the PGIC scale | Posted | Count of Participants | Participants | 3 month |
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| Secondary | PGIC Improvement | The number of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale | Posted | Count of Participants | Participants | 6 month |
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| Secondary | PGIC Improvement | The number of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale | Posted | Count of Participants | Participants | 12 month |
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| Secondary | PGIC Improvement | The number of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale | Posted | Count of Participants | Participants | 18 month |
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| Secondary | PGIC Improvement NOTE: The Study Ended Before Month 24 Data Could be Gathered. | The proportions of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale | Not Posted | 24 month | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | The Pain and Sleep Questionnaire Three-item Index (PSQ-3) | The number of participants who had improvement in pain-related sleep disturbance as measured by the PSQ-3. This index measures the impact of pain on sleep in chronic pain using 3 questions:
There are six answers participants will choose from for each question with a corresponding score: Always=1, Very Frequently = 2, Occasionally = 3, Rarely = 4, Very Rarely = 5 and Never = 6. A high score indicates that the participant's back pain is not interfering with their sleep. Lower scores mean the participant's back pain is interfering with their sleep. | Posted | Count of Participants | Participants | 3 Months |
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| Secondary | The Pain and Sleep Questionnaire Three-Item Index (PSQ-3) | The number of participants who had improvement in pain-related sleep disturbance as measured by the PSQ-3. This index measures the impact of pain on sleep in chronic pain using 3 questions:
There are six answers participants will choose from for each question with a corresponding score: Always=1, Very Frequently = 2, Occasionally = 3, Rarely = 4, Very Rarely = 5 and Never = 6. A high score indicates that the participant's back pain is not interfering with their sleep. Lower scores mean the participant's back pain is interfering with their sleep. | Posted | Count of Participants | Participants | 6 Months |
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| Secondary | The Pain and Sleep Questionnaire Three-Item Index (PSQ-3) | The number of participants who had improvement in pain-related sleep disturbance as measured by the PSQ-3. This index measures the impact of pain on sleep in chronic pain using 3 questions:
There are six answers participants will choose from for each question with a corresponding score: Always=1, Very Frequently = 2, Occasionally = 3, Rarely = 4, Very Rarely = 5 and Never = 6. A high score indicates that the participant's back pain is not interfering with their sleep. Lower scores mean the participant's back pain is interfering with their sleep. | Posted | Count of Participants | Participants | 12 Months |
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| Secondary | The Pain and Sleep Questionnaire Three-Item Index (PSQ-3) | The number of participants who had improvement in pain-related sleep disturbance as measured by the PSQ-3. This index measures the impact of pain on sleep in chronic pain using 3 questions:
There are six answers participants will choose from for each question with a corresponding score: Always=1, Very Frequently = 2, Occasionally = 3, Rarely = 4, Very Rarely = 5 and Never = 6. A high score indicates that the participant's back pain is not interfering with their sleep. Lower scores mean the participant's back pain is interfering with their sleep. | Posted | Count of Participants | Participants | 18 Months |
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Study procedure-related adverse events will be documented from the time the informed consent form is signed by a participant until the end of the study at 24 months following the study procedure. As the study discontinued early, the longest a participant was followed was 18 months.
As per protocol, only procedure-related adverse events (e.g., cardiopulmonary compromise, neurologic deficits, numbness, ataxia, vasovagal syncope and neuritis) will be collected. These AEs/SAEs will be collected at the procedure visit, by participant report and from the EMR system throughout the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG001 | 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.
| 0 | 12 | 0 | 12 | 0 | 12 |
Not provided
Not provided
Due to slow enrollment, the sponsor discontinued the study before the target goal of 116 randomized participants was met. It was determined that the amount of data collected for this study was insufficient for a statistically reliable analysis.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron Conger, DO | University of Utah | 801-213-6980 | Aaron.Conger@hsc.utah.edu |
| May 6, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG001 | 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.
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| OG001 | 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.
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| OG001 | 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.
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| OG001 | 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.
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| OG001 | 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.
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| OG001 | 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.
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| OG001 | 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.
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| OG001 | 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.
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