Ultrasound-guided Sacroiliac Joint Radiofrequency Ablation: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Numeric rating scale for pain
研究概览
简要总结
The sacroiliac (SI) joint is a common source of low back pain. Radiofrequency ablation (RFA) can be used to treat low back pain from the SI joint , and is often recommended by physicians to provide long lasting pain relief. However, the use of RFA for SI joint pain has not been as successful as RFA for pain in other areas of the back and neck. X-ray guidance (fluoroscopy) is currently used to perform this procedure. Under fluoroscopy, however, it can be difficult for physicians to identify necessary landmarks, and there are risks to the patient because of radiation exposure. In contrast, ultrasound may provide better image guidance than fluoroscopy, and there is no radiation risk. The purpose of this study is to examine if ultrasound guided SI joint RFA is effective.
详细描述
Background:
This study will examine the effectiveness of sacroiliac joint (SIJ) diagnostic sensory blocks and radiofrequency ablation (RFA) under ultrasound guidance. The sacroiliac joint (SIJ) is estimated to be the source of pain in 10-27% of patients suffering from mechanical low back pain. When pain is refractory to conventional treatments (such as activity modification, exercise, physical therapy, chiropractic, anti-inflammatory and analgesic medications and corticosteroid injections), radiofrequency ablation (RFA) is a treatment option in carefully selected individuals.
Current practice is to perform the SIJ posterior sensory blocks and RFA under fluoroscopic guidance. Research has confirmed that SIJ RFA can provide significant relief, however, the success rate and magnitude of relief are variable. Part of this variability may relate to the challenging nature of identifying key anatomical landmarks under fluoroscopy - their location may not be clearly evident with fluoroscopy particularly if the patient is obese, has low bone mineral density or has abundant bowel gas and/or stool in the pelvis.
A recent cadaveric study by our research group has clarified the sensory innervation of the SIJ and the findings have implications for currently practiced SIJ sensory block and RFA procedures. The study confirmed that the posterior sacral network innervates the SIJ and runs along the lateral crest of the sacrum between the S1 and the S3 lateral sacral tubercles. Inasmuch as the lateral sacral crest is predictably and clearly visible on ultrasound, posterior sacral network (PSN) SIJ sensory blocks and RFA under ultrasound guidance may be feasible using the lateral sacral crest as the key anatomical structure.
No clinical studies have been done that use ultrasound guidance for SIJ RFA. There are numerous advantages to ultrasound-guided SIJ sensory block and RFA. Significantly, patients would no longer be exposed to ionizing radiation for their SIJ procedures. With an improved understanding of SIJ sensory innevation and technical improvements in RFA electrodes, we hypothesize that ultrasound guided SIJ diagnostic sensory blocks and RFA will lead to clinically significant outcomes that will be at least comparable to conventional fluoroscopic-guided techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Clinical presentation compatible with SI joint origin pain (back pain below L5; localized to the SI joint area; >2 positive of 5 SI joint provocative tests).
- •>50% index pain relief with at least one SIJ intra-articular local anesthetic block and at least one SIJ lateral branch block using the conventional fluoroscopically guided lateral branch block technique. Pain diary records for these interventions need to be on file.
排除标准
- •Under 18 years of age
- •Presence of clinical and investigative evidence of inflammatory spondyloarthropathy, fibromyalgia, radiculopathy, symptomatic spinal stenosis, facetogenic or discogenic low back pain, generalized infection, localized infection in the area of the low back/SIJs, coagulopathy or anticoagulation, allergy to local anesthetic
研究组 & 干预措施
PSN block and RF ablation
Participants will first undergo a lidocaine block of the PSN at the lateral crest under ultrasound guidance. On a separate visit, participants will then undergo ablation of the PSN at the lateral crest under ultrasound-guidance.
干预措施: Radiofrequency ablation (Procedure)
PSN block and RF ablation
Participants will first undergo a lidocaine block of the PSN at the lateral crest under ultrasound guidance. On a separate visit, participants will then undergo ablation of the PSN at the lateral crest under ultrasound-guidance.
干预措施: Sensory block (Procedure)
PSN block and RF ablation
Participants will first undergo a lidocaine block of the PSN at the lateral crest under ultrasound guidance. On a separate visit, participants will then undergo ablation of the PSN at the lateral crest under ultrasound-guidance.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Numeric rating scale for pain
时间窗: Hourly for 6 hours post-block
Pain diary scores for first 6 hours post-block
Pain Disability Quality-of-Life Questionnaire (PDQQ-S)
时间窗: 2 months post-RF procedure
The PDQQ-S is a 6 item questionnaire exploring 3 domains: pain, disability and quality-of-life. There are 2 questions for each domain and each is graded from 0 to 10 using a numerical rating scale. Ultrasound-guided SIJ RFA results will be compared to previous fluoroscopic-guided SIJ RFA results at 2 months.
次要结局
- Pain Disability Quality-of-Life Questionnaire (PDQQ-S)(6, 9, 12, 16, 20 and 24 months post-RF procedure)
研究者
Eldon Loh
Assistant Professor
Western University, Canada