A Prospective, Single-center, Pilot Study of in Vivo Lesion Characteristics Post Coolief Cooled Radiofrequency Denervation as a Treatment for Chronic Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Cooled radiofrequency ablation lesion size
研究概览
简要总结
This Prospective, Single-center, Pilot Study will assist in gaining an understanding of the actual CRFA lesions in an in vivo situation in areas where CRFA is utilized as a standard of care treatment option for the relief of chronic pain (cervical facet joints, thoracic facet joints, lumbar facet joints, Sacroiliac (SI) region, hip and knee).
详细描述
This study will be a prospective, single-center, pilot study. Adult subjects over the age 21 diagnosed with chronic joint pain (≥ 3 months), scheduled to receive Radiofrequency denervation and meet the selection criteria are eligible to participate in this study. The specific targeted areas of interest in this study will include Cervical facet joints, Thoracic facet joints, Lumbar facet joints, Sacroiliac (SI) region, hip and knee.
The treating physician will follow Standard of Care treatment for all enrolled subjects. As illustrated in Figure 1, the study consists of a screening visit, a treatment visit and a follow up visit. All subjects receiving CRFA will receive an MRI 2 - 7 days after the CRFA procedure. Subjects receiving CRFA of the Sacroiliac Joint will also receive an MRI within 30 days prior to the CRFA procedure. The treating physician may also request an MRI be performed prior to the procedure for subjects receiving CRFA of other targeted areas. The point of enrollment for each subject is the time that they sign the Informed Consent Form.
MRI data will be reviewed by the radiologist on a per patient basis to confirm lesion characteristics. It is anticipated that 3-5 subjects per level will be needed to fully quantify lesion characteristics, however; enrollment will remain flexible for each targeted area based on real time review of MRI data.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 21 years
- •Able to understand the informed consent form and provide written informed consent and able to complete outcome measures.
- •Must be clinically appropriate candidate to receive CRFA for treatment of chronic pain.
- •Willing and able to receive an MRI
排除标准
- •Unable to receive an MRI (i.e. due to pacemaker or iron-based metal implant).
- •Unable to receive an MRI (i.e. iron-based metal implant).
- •Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency lesion of up to 14mm in diameter to limit the risk of skin burns.
- •Active joint infection or systemic or localized infection at the needle entry site (subject may be considered for inclusion once infection is resolved.)
- •Subject currently implanted with a pacemaker or defibrillator
- •In the event a pre-treatment MRI is obtained; trauma or injury occurring to the targeted area between the baseline MRI and CRFA treatment
- •Subject unwillingness or unable to comply with protocol requirements
研究组 & 干预措施
Cooled radiofrequency ablation
This is a single arm study. Patients who will be undergoing cooled radiofrequency ablation for the treatment of arthritis in the cervical facet joints, thoracic facet joints, lumbar facet joints, sacroiliac (SI) region, hip and knee.
干预措施: Cooled radiofrequency ablation (Device)
结局指标
主要结局
Cooled radiofrequency ablation lesion size
时间窗: MRI obtained between 2-7 days post-procedure.
Size in millimeters of cooled radiofrequency ablation lesion via MRI
次要结局
- Pain relief(2-4 weeks post-procedure as compared to pre-procedure)