Technical Efficacy of a Direction Specific Radiofrequency Device in the Performance of Lumbar Medial Branch Neurotomies - an MRI and EMG Confirmation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Percentage of Patients With Magnetic Resonance Imaging (MRI) Evidence of Tissue Ablation/Edema at Targeted Lumbar Medial Branches
研究概览
简要总结
The purpose of this study is to document the effectiveness of the Nimbus Multi-tined Expandable Electrode (MEE) Probe in carrying out the heating and ablation (cutting) of the small medial branch nerves that carry pain information from the facet joints. Subjects will be selected, by way of clinical evaluation and response to medial branch blocks, to undergo this procedure of radiofrequency ablation/neurotomies of the medial branches to the specific painful facet joints of the low back in order to relieve pain. This will be carried out with an FDA-approved device using a standard technique that has been accepted throughout the world. The difference in this study is that we will make use of MRIs to image the lesion that is produced and a special EMG study to look at the muscles in the back to document the effectiveness of the device in creating the intended lesion. No other study of this kind has been produced to look at this or any other radiofrequency device in the treatment of low back pain.
详细描述
Study Timeline, Outline, and Methods
- Initial evaluation with physician and study eligibility determination
- Presentation of study to patient and informed consent obtained
- Baseline paraspinous muscle EMG performed
- MB (medial branch)/DR (dorsal ramus) radiofrequency neurotomy with Nimbus MEE probe (start date)
- Post-operative soreness managed with oral and topical medications and possibly 1-4 physical therapy sessions, as needed
- MD visit at intake evaluation and at 3 and 6 weeks following the procedure.
- Paraspinal needle electromyography, using the mini-paraspinal mapping ("miniPM") technique of Haig will be carried out at baseline (pre-procedure) and between 3 and 6 weeks post-procedure.
- MRI, with sequencing which allows for volumetric calculations (see Appendix III), will be obtained on all of the ten chosen subjects at 7 days post-procedure. If there is any evidence of edema or coagulation changes with volume of greater than 600 cubic mm, or evidence of bony edema or other changes believed to be due to the procedure, then a follow up MRI will be obtained at 14 days post-procedure. If bony edema changes are present at 14 days, repeat MRI will be obtained at 6 weeks post-procedure.
- Procedural details, including procedural and fluoroscopy times, will be collected for each subject. A matched cohort of patients who have undergone MB RFN (radiofrequency neurotomy) using the previous/current method have had the same data obtained for group comparisons.
Lumbar Paraspinal Mapping:
The adequate cauterization of the targeted medial branches will be confirmed using the paraspinal mapping (PM) technique of Haig. This testing will be carried out on all subjects at 3-6 weeks post radiofrequency neurotomies, by electromyographers blinded to the side and levels of the procedure. Subjects found to have reliable evidence of spontaneous electrical activity, as detailed in, will be deemed to have had a successful denervation of the medial branch in question.
Baseline PM will also be carried out at enrollment to document a normal baseline and to rule out the presence of spontaneous activity from other underlying pathology. Those found to have findings of spontaneous activity, upon baseline needle EMG of the lumbar paraspinals, will be excluded from the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a low back pain episode greater than three months in duration, unresponsive to non-interventional care, have had a lumbar MRI which is available for review, who have been selected to undergo lumbar medial branch RF lesioning and who have agreed to undergo pre and post procedure EMG and post procedure lumbar magnetic resonance imaging (LMRI).
- •Age 18 or greater
- •Appropriately selected patients using at least one set of diagnostic medial branch blocks
- •Exclusion Criteria
- •Inability to attend EMG, MRI assessments within the defined assessment time windows
- •Radicular pain or evidence of neurological compromise in the lower limbs (see clarification above - Target Population).
- •Those unable to read English and complete the informed consent process
- •Spondylolysis or lytic spondylolisthesis, degenerative spondylolisthesis which is Grade II+ or unstable.
- •Systemic inflammatory, toxic, corticosteroid induced or congenital myopathy, or inflammatory arthritis
- •Possible pregnancy or other reason that precludes the use of fluoroscopy, MRI, or EMG
- •Significant lumbar scoliosis (Cobb angle > 15 degrees).
- •Radicular/neurological deficits or focal disc herniation and/or stenosis, with correlating radicular symptoms (defined as pain or paresthesias below the knee; pain reproduction with straight leg raising; leg > back pain with extension/rotation maneuvers; radicular strength, reflex, or sensory changes consistent with their level of nerve root impingement).
- •Immunologically suppressed, or has received steroids at any dose daily for > 1 month within last 12 months
- •Currently involved in another study or treatment that may affect the outcome of this study
- •Evidence of spontaneous activity (denervation potentials) on baseline EMG
排除标准
- 未提供
结局指标
主要结局
Percentage of Patients With Magnetic Resonance Imaging (MRI) Evidence of Tissue Ablation/Edema at Targeted Lumbar Medial Branches
时间窗: 7 days
Documentation of Magnetic Resonance Imaging (MRI) evidence of tissue ablation/edema at targeted lumbar medial branches as they course around the superior articular process and transverse process juncture of the vertebrae
Volume of Lesions Were Recorded by the Reading Radiologists
时间窗: 7 days
Volume of lesions were recorded by the reading radiologists, including proximity to medial branches
EMG Evidence of Lesion of the Targeted Medial Branches
时间窗: 3-6 weeks post radiofrequency ablation
EMG evidence of lesion of the targeted medial branches (Percentage of positive lesions)
次要结局
- Number of Participants With Serious and Non-Serious Adverse Events(Up to 6 weeks)