Efficacy of Fluoroscopic Versus Ultrasound Guided Sacroiliac Joint Radiofrequency Ablation: A Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Pain reduction: change from baseline pain scores
研究概览
简要总结
The sacroiliac joint (SIJ) is estimated to be the source of low mechanical back pain in 10-27% of patients. When conservative measures for treating SIJ pain fail (physiotherapy, exercise, analgesic medications, chiropractic manipulation, etc.) radiofrequency ablation (RFA) is a treatment option in carefully selected patients. RFA uses a radiofrequency generator to create a thermal lesion, with the aim of ablating the nerves that innervate the SIJ complex. Studies have confirmed that SIJ RFA can provide significant relief for patients with SIJ pain. The current gold standard is the use of fluoroscopic (x-ray guidance) to visualize bony landmarks in order to create an accurate thermal lesion along the lateral sacral crest; where the nerves that innervate the SIJ complex reside. Recent literature has proposed a technique for an ultrasound-guided approach to achieve an RFA lesion in patients with SIJ pain. It is proposed that with ultrasound-guidance, versus fluoroscopic-guidance, the interventionalist is able to perform fewer needle passes for the procedure, as well as fewer thermal lesions, thereby achieving shorter performance times. The proposed study serves as a non-inferiority randomized controlled trial to assess the effectiveness of ultrasound-guided versus fluoroscopy-guided RFA for the treatment of SIJ pain.
详细描述
Current practice for SIJ pain that is refractory to conservative treatment, is the use of RFA of the posterior sacral network under fluoroscopic-guidance. There is high variability regarding the long-term benefits of this procedure. To date, there have been no clinical studies evaluating the effectiveness of US-guided RFA procedures for SIJ pain. A study performed in 2017 attempted to determine the effectiveness of US-guided sacral LBBs compared to fluoroscopic-guidance (gold standard in current practice). The results were in favour of an US-guided approach. Compared with fluoroscopy, US-guided sacral lateral branch blocks required a shorter performance time, fewer needle passes, and was associated with a lower incidence of vascular breach. Furthermore, with an US-guided procedure, the patient is no longer exposed to ionizing radiation.With an improved understanding of SIJ sensory innervation, as well as technical improvements in RFA electrodes, it is postulated that RFA under ultrasound-guidance will lead to non-inferior clinical outcomes, as well as shorter performance time and reduced costs compared with the current practice of fluoroscopic-guidance.
The objectives of the current study are the following:
- To evaluate the efficacy of US-guided posterior sacral network SIJ RFA compared to fluoroscopy-guided SIJ RFA.
- To compare the post-procedure pain/flare-up and duration required to achieve full recovery for each approach.
- To perform a cost effectiveness analysis comparing ultrasound and fluoroscopy-guided SIJ RFA.
- To determine the safety of US-guided SIJ RFA by tracking intra-operative and post-procedure complications.
Research Method/Procedures:
The proposed study is a single-blind, single-center randomized controlled trial. Patients who present with pain thought to be originating from the SIJ will be screened for study participation with fluoroscopy-guided sacral LBBs. If a patient has an initial successful sacral LBB (defined as 70% reduction in pain), or has prior successful SIJ RFA, they will be approached for consent to be contacted for study participation by a member of the HealthPointe team; specifically, patients who consent to be contacted for study participation, will have their charts reviewed by independent assessors for inclusion and exclusion criteria. If a patient meets the inclusion criteria (listed below), they will be contacted by a HealthPointe team member, specifically a nurse or care manager, for study participation. If the patient expresses an interest with the initial contact, they will be subsequently contacted by a study sub-investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
In terms of blinding, the principal investigators will be blinded to which arm each study participant is randomized to. It is not possible to blind study participants, as they will be aware of the imaging modality used to perform the procedure. The clinicians serving as private investigators (one in each study arm) will not be blinded to the procedure they are performing. Therefore, this is a single-blinded study
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
- •Body Mass Index (BMI) ≤35
- •Clinical presentation must be in keeping with SIJ pain based on both history (pain below L5 vertebrae, localized to the SIJ area, back pain greater than leg pain) and/or physical examination (≥2/5 SIJ provocative tests).
- •Diagnosis confirmed by having >70% index pain relief with fluoroscopy-guided SIJ lateral branch blocks (with local anesthetic). Participants will require confirmatory lateral branch block under their respective image modality once randomized, requiring >70% pain relief for diagnosis, prior to completing the randomized SIJ RFA procedure.
排除标准
- •Pregnant or inadequate birth control methods (to prevent the exposure of a pregnant female and/or fetus to radiation).
- •Inflammatory spondyloarthropathy
- •Fibromyalgia
- •Radiculopathy (will require an electromyography study to rule out radiculopathy if clinically suspected in patients with primarily buttock pain)
- •Discogenic low mechanical back pain
- •Symptomatic spinal stenosis
- •Generalized or local infection
- •Coagulopathy
- •Allergy to local anesthetic
结局指标
主要结局
Pain reduction: change from baseline pain scores
时间窗: 6 weeks to 18 months post-procedure.
Visual analog scale (VAS) for pain at the various follow-up time periods. The visual analog scale is a numerical scale from 0 to 10; with 0 representing no pain and 10 representing the worst pain imaginable.
Function and quality of life
时间窗: 6 weeks to 18 months post-procedure.
Pain, Disability and Quality of Life Questionnaire- Spine (PDQQ-S)
次要结局
- Cost effectiveness(Costs compared based on procedural data upon study completion, an average of 18 months.)
- Post-procedure pain flare(Daily visual analog scale (VAS) for pain for the first 6 weeks.)
- Pain medication usage(6 weeks to 18 months post-procedure.)