常规或双极 SIJ RFA
常规或双极射频消融治疗骶髂关节疼痛？ COBRA-SIJ 研究，一项双盲、随机、比较试验。
具体目标 骶髂关节复合体 (SIJC) 是一个动臂、滑膜关节和后韧带网络，它接收来自腰骶丛的前部神经支配以及通过后骶骨网络 (PSN) 接收后部感觉神经支配。 PSN 由侧支 S1-S3 后支组成，S4 侧支和 L5 背支的贡献各不相同。 源自 SIJC 的疼痛信号可以通过 PSN 的图像引导经皮射频消融术 (RFA) 中断，从而减少精心挑选的患者的疼痛和残疾。
一项先前的系统评价估计，32-89% 的患者在接受某种类型的 PSN 消融后六个月内疼痛至少减轻 50%。 许多专家怀疑，不同的 RFA 技术和技术是导致已发表研究中出现不同成功率的原因。 尸体研究表明，与可能捕获低至 2.5% 的 PSN 的传统、单极、椎间孔 RFA 技术产生的较小损伤相比，以大的双极条带损伤为目标的 PSN 将导致 >95% 的 PSN 神经捕获。 Nimbus 是一种常用的多齿 RFA 探头，其大双极病变尺寸使其成为完全 PSN 神经消融的理想选择。 Nimbus（N-SIJRFA）和conventional（C-SIJRFA）技术和技术都是常用的；然而，没有前瞻性随机对照试验对它们进行比较，临床意义仍然未知。
问题：没有比较 N-SIJRFA 和 C-SIJRFA 等新技术的随机对照试验。
目的：比较随机分配至 N-SIJRFA 或 C-SIJRFA 后确诊 SIJC 疼痛患者的疼痛和残疾结果。
中心假设：在 3、6、12、18 和 24 个月时，与接受 C-SIJRFA 治疗的患者相比，N-SIJRFA 将更有效地改善疼痛和功能。
具体目标：
1. 比较 N-SIJRFA 与 C-SIJRFA 后通过数字疼痛评定量表 (NPRS) 报告疼痛缓解≥50% 的参与者比例。
研究概览
详细说明
腰痛会影响大多数人一生中的某个时期。 2015 年腰痛的估计点患病率为 7.3%，表明在任何特定时间都有 5.4 亿人可能受到影响 (1)。 腰痛的病因可能是多因素的，但通常在多达 15-30% 的患者中通常归因于由伤害性感受引起的骶髂关节复合体 (SIJC) (2)。 SIJC 是一种动臂滑膜关节，它既接受来自腰骶丛的前部神经支配，也接受来自后骶骨网络 (PSN) 的后部感觉神经支配 (3)。 PSN 由侧支 S1-S3 后支组成，S4 侧支和 L5 背支的贡献各不相同 (3-6)。 这些已成为神经切开术的目标，最常见的是图像引导经皮射频消融术 (RFA) (7)，但也有经皮冷冻神经松解术 (8)、化学神经松解术 (9)、内窥镜引导 RFA (10) 和 MRI 高频超声治疗 (MRI-HIFU) (11)。
先前的系统回顾表明，32-89% 的患者可能在六个月内实现至少 50% 的疼痛缓解，而同期 11-44% 的患者实现 100% 的疼痛缓解 (12)。 尽管患者选择的因素可能会影响此估计 (13)，但研究已使用各种不同的 RFA 技术来瞄准 PSN，这也可能影响成功率。 很少有研究直接比较这些技术，但尸体研究表明，与使用传统单极电极进行的椎间孔周围 RFA 相比，用双极带状病变靶向 PSN 会产生更高的神经捕获率 (6)。 此外，传统单极 RFA 的完全神经捕获率可能低至 12.5%，这可能是一些临床研究表明在使用已知会产生更大病变的技术治疗的群体中成功概率增加的原因之一 (13, 14). 对于传统单极技术与较大的冷却单极损伤 (15) 以及大型连续损伤多电极损伤与传统单极技术 (16) 之间的椎间孔技术，观察到了类似的效果。 然而，没有研究直接比较使用“栅栏”技术 (N-SIJRFA) 的双极带状病变与传统的单极椎间孔方法，后者在许多实践环境中普遍使用。
本研究的主要目的是评估 PSN 的 RFA 的有效性，使用双极“栅栏”技术创建连续条状病变，与传统的单极椎间孔技术相比，治疗骶髂关节复杂疼痛患者。 鉴于最近的尸体研究结果，拟议工作的结果可能会对 PSN 神经切断术的当前治疗模式产生重大影响。
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Utah
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Farmington、Utah、美国、84025
- University of Utah Farmington Health Center
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Salt Lake City、Utah、美国、84108
- University of Utah Orthopaedic Center
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South Jordan、Utah、美国、84009
- University of Utah South Jordan Health Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准：
- 年龄在 18-90 岁之间且腰痛至少 3 个月且对至少 3 个月的保守治疗无反应的成年参与者。
- 基线时腰痛的 7 天平均 NPRS 至少为 4/10
- 通过荧光镜引导的关节内骶髂关节注射（包括局部麻醉剂和荧光镜引导的 PSN 阻滞）或双荧光镜引导的 PSN 阻滞，疼痛至少减轻了 50%。
- 参与者能够理解英语并提供同意书，并且能够遵守所使用的结果工具。
将提供带有适当诊断缓解类别（100% 缓解、80-99% 缓解等）的疼痛日记。 不会使用止痛持续时间，因为它已被证明只能略微提高诊断信心 (17)。
排除标准：
- SIJ 融合的历史。
- 有症状的髋骨关节炎
- 活动性腰椎根性疼痛
- 硬件松动的证据（在有腰椎或腰骶融合病史的参与者中）。
- 起搏器或神经刺激器的存在。
- 慢性广泛性疼痛或躯体形式障碍（例如，纤维肌痛）。
- 每天使用超过 50 毫克吗啡当量的阿片类药物。
- 过去 4 周内有活动性细菌感染或用抗生素治疗感染。
- 导致严重功能障碍的医疗状况（例如中风、慢性阻塞性肺病）。
- 成瘾行为、严重的临床抑郁症或精神病特征。
- 对使用的任何药物有过敏反应史。
- 因疼痛治疗而获得报酬的人（例如残疾、工伤赔偿）。
- 那些参与与他们的痛苦相关的积极诉讼的人。
- 参与者被监禁。
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Nimbus 骶髂关节射频消融术 (N-SIJRFA)
N-SIJRFA - 使用双极“栅栏”技术创建连续的条状损伤。
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有源比较器：常规骶髂关节射频消融术 (C-SIJRFA)
C-SIJRFA - 使用传统的单极椎间孔技术
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change in Numeric Pain Rating Score
大体时间：3 month
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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
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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EQ-5D改进
大体时间：24个月
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在 EuroQol 5 维度分类工具 (EQ-5D) (20) 中有临床显着改善的患者比例定义为治疗后≥0.03
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24个月
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Percent of Relief Using the Numeric Pain Rating Scale
大体时间：6 month
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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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Percent of Relief Using the Numeric Pain Rating Scale
大体时间：12 month
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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
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Percent of Relief Using the Numeric Pain Rating Scale
大体时间：18 month
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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
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Percent of Relief Using the Numeric Pain Rating Scale. NOTE: The Study Ended Before Month 24 Data Could be Gathered.
大体时间：24 month
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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
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Oswestry Disability Index (ODI) Reduction
大体时间：3 month
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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:
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3 month
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Oswestry Disability Index (ODI) Reduction
大体时间：6 month
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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:
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6 month
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Oswestry Disability Index (ODI) Reduction
大体时间：12 month
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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:
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12 month
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Oswestry Disability Index (ODI) Reduction
大体时间：18 month
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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:
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18 month
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Oswestry Disability Index (ODI) Reduction NOTE: The Study Ended Before Month 24 Data Could be Gathered.
大体时间：24 month
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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:
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24 month
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EQ-5D Improvement
大体时间：3 month
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The number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments
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3 month
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EQ-5D Improvement
大体时间：6 month
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The number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments
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6 month
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EQ-5D Improvement
大体时间：12 month
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The number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments
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12 month
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EQ-5D Improvement
大体时间：18 month
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The number of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) (20) defined by ≥0.03 following treatments
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18 month
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Patient Global Impression of Change (PGIC) Improvement
大体时间：3 month
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The number of participants who report being "improved" or "much improved" on the PGIC scale
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3 month
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PGIC Improvement
大体时间：6 month
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The number of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale
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6 month
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PGIC Improvement
大体时间：12 month
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The number of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale
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12 month
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PGIC Improvement
大体时间：18 month
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The number of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale
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18 month
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PGIC Improvement NOTE: The Study Ended Before Month 24 Data Could be Gathered.
大体时间：24 month
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The proportions of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale
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24 month
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The Pain and Sleep Questionnaire Three-item Index (PSQ-3)
大体时间：3 Months
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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
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The Pain and Sleep Questionnaire Three-Item Index (PSQ-3)
大体时间：6 Months
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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
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The Pain and Sleep Questionnaire Three-Item Index (PSQ-3)
大体时间：12 Months
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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
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The Pain and Sleep Questionnaire Three-Item Index (PSQ-3)
大体时间：18 Months
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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
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合作者和调查者
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
- Bogduk N. On the Rational Use of Diagnostic Blocks for Spinal Pain. Neurosurg Q. 2009 Jun;19(2):88-100.
- 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.
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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