Randomized Controlled Trial Of Minimally Invasive Sacroiliac Joint Fusion Compared To Radiofrequency Ablation For Sacroiliac Joint Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Treatment success
研究概览
简要总结
Patients diagnosed with chronic SIJ pain that can be treated by sacroiliac joint fusion or radiofrequency ablation. The radio frequency ablation is performed using either conventional or "cooled" techniques aimed at the S1-S3 lateral branches and the L5 dorsal ramus. Minimally invasive sacroiliac joint consists of implanting 2 to 3 metallic implants inside the SIJ to increase the stability and eventually fuse the SIJ. This randomized controlled trial aims at comparing treatment success at 6-month follow-up time-point after minimally invasive sacroiliac joint fusion and radiofrequency ablation for chronic SIJ dysfunction.
详细描述
Introduction This document is a protocol for a human research study. This study is to be conducted according to US and international standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), applicable government regulations and Institutional research policies and procedures.
Background
Sacroiliac joint (SIJ) dysfunction is a common pain condition involving the buttock and may irradiate in the low back, groin and/or lower extremity. About one in five patients with low back pain is estimated to have SI joint pain. The economic burden of SIJ pain is high in the United States and there is a need for more cost effective treatment options. There is a lack of relevant high quality studies that compared nonsurgical and surgical treatment for SI joint dysfunction.
Sacroiliac joint (SIJ) dysfunction has been estimated to be the origin of lower back pain in 13 to 30% of patients. SIJ pain is usually referred to the buttock, low back, groin and/or lower extremity. SIJ osteoarthritis, trauma, SIJ degeneration following lumbar fusion and postpartum SIJ dysfunction are common causes of SIJ pain found in a clinical setting. Other less common causes for SIJ pain include inflammatory sacroiliitis, infective sacroiliitis, insufficiency stress fractures and neoplasia.
Diagnostic evidences for SIJ dysfunction
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)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Once the informed consent has been obtained, the following screening procedures/tests will be performed:
- •Local anesthetic sacroiliac joint block and steroid injection performed by a qualified Ochsner pain management provider in less than 3 months following the consent date
- •The subject will rate his pain level using the VAS at 2, 4, 6, 8 and 10 hours after the sacroiliac joint block and steroid injection
- •Patient will be excluded from the study if they do not meet this criteria: VAS defined as at least 75% pain relief that is sustained for at least 2 hours in a 10 hours period after the block
- •Sacroiliac joint injection will be done without any analgesics but anti anxiety medication can be used on case by case based
- •The subject will attend a follow-up visit at 6 weeks after the SIJ block and steroid injection. During this visit if the subject's VAS has recurred to at least 50mm the patient will be randomized in either sacroiliac joint fusion or radiofrequency ablation.
- •Subjects with VAS smaller than 50mm will be seen at 12 weeks of follow-up. During this visit if the subject's VAS has recurred to at least 50mm the patient will be randomized in either sacroiliac joint fusion or radiofrequency ablation. Subjects with smaller that 50mm VAS will be excluded from randomization at this time point.
- •Inclusion Criteria:
- •Participation will be offered by treating physicians during an outpatient visit in the neurosurgery or pain management clinic. Subjects need to meet all inclusion criteria in order to participate in the study.
- •Male or female
- •Age ≥ 18 years old
- •Subject is willing and able to give informed consent for participation in the study
- •Unilateral or bilateral SIJ pain for more than 50 days
- •Persistent SIJ pain despite a trial of physical therapy for SI joint pain
- •Agreement to avoid conception during trial
- •Average VAS of at least 50 mm
- •Minimal ODI score of at least 40%
- •Etiology of SIJ dysfunction: osteoarthritis, past surgical history of lumbar or lumbosacral fusion, traumatic injury, post-partum.
- •The SIJ pain can not be explained by a lumbar spine pathology seen on MRI: (disc herniation, lateral recess stenosis, moderate or severe spinal stenosis, synovial cyst, mass)
- •Successful SIJ injection based on criteria discussed in recruitment section
排除标准
- •All participants meeting any of the exclusion criteria at baseline will be excluded from study participation.
- •Neurological deficit
- •History of cancer
- •Active spinal or systemic infection
- •Past medical history or active psychiatric condition
- •Prohibited drug use
- •Subject with pacemaker
- •Pregnancy or Breastfeeding
研究组 & 干预措施
Sacroiliac joint fusion
The subject will receive a sacroiliac joint fusion
干预措施: Sacroiliac joint fusion (Procedure)
Sacroiliac radio frequency ablation
The subject will receive a sacroiliac joint radiofrequency ablation
干预措施: Sacroiliac joint radiofrequency ablation (Procedure)
结局指标
主要结局
Treatment success
时间窗: 6 months after the intervention
Comparison in the proportion of subjects having a success between groups at 6-month follow-up time-point. Treatment success is defined as a ≥ 50% decrease in VAS pain score; a 10-point increase in SF-36BP (amelioration); a 15-point decrease in ODI (amelioration); absence of device-related serious adverse events; absence of focal neurological deficit or neuropathic pain related to lumbosacral nerve roots injury and absence of surgical reintervention for SIJ pain (revision, removal of hardware, additional fixation)
次要结局
- Cost-effectiveness between SIJ fusion and radio frequency ablation(6 months after the intervention)
- Mean changes from baseline in visual analog score for pain(6 months after the intervention)
- Radiofrequency ablation subgroups analysis(6 months after the intervention)
- Mean changes from baseline in Oswestry Disability Index score(6 months after the intervention)
- Mean changes from baseline in SF-36 physical component summary score(6 months after the intervention)
- Mean changes from baseline in SF-36 mental component summary score(6 months after the intervention)
研究者
Daniel Denis
Neurosurgeon staff at Ochsner Medical Center and Clinical Assistant Professor, Dept. Neurosurgery, Tulane University School of Medicine
Ochsner Health System