Evaluation of Peripheral Nerve Stimulation as an Alternative to Radiofrequency Ablation for Facet Joint Pain
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Multifidus muscle activity
研究概览
简要总结
Radiofrequency ablation of the medial nerve is the current surgical treatment for back pain originating from the facet joints in the spine. However, this procedure causes denervation of spinal muscles. Peripheral nerve stimulation is another treatment for facet joint pain that may not cause damage to the spinal muscles. This study will compare both treatments in terms pain relief and spine biomechanics.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range (18-80 years): The age range of the patient population at Hershey Medical Center with facet pain is 24 to 90 years old, with a mean age of 63 years old. Due to the physical tests planned in the study, the maximum age limit will be restricted to 80 years old.
- •English Speaking: Adults who only speak other languages will not be included because of the lack of feasibility of employing reliable instruments and interviewers fluent in other languages.
- •Facet Joint Pain: male and female patients having a diagnosis of facet joint pain based upon accepted diagnostic criteria (i.e., two positive nerve blocks) and assessed by an experienced physical therapist or physician.
- •Indication for Surgical Procedure: Physical therapy is the first line of action for facet joint pain. If PT is not effective, patients are eligible for RFA or PNS.
排除标准
- •Previous Spinal Conditions Surgery: We will exclude patients with other spinal conditions like scoliosis or who have received previous spinal surgeries.
- •Systemic neurological or neuromuscular disease: Such disorders (e.g., stroke, muscular dystrophy, myopathies) affect muscle and may confound muscle data and/or balance and physical performance data.
- •Allergic reaction to ultrasound gels: It is possible, although rare, that patients develop allergic reaction to ultrasound gels. Those subjects will be excluded from the study.
- •Physical Activity: Subjects will be asked to fill out the Physical Activity Readiness Questionnaire (PAR-Q), and if they answer yes to any of the questions, they need to be cleared by their physician prior to participating in the study.
- •Current infection, illness, or condition: Individuals with a current infection, illness, or condition (e.g., uncontrolled blood pressure, pregnancy) that may affect their ability to safely participate will be excluded.
- •Mental incompetency: Individuals who cannot legally consent themselves to the surgical procedure and participation in the research study, will not be considered for inclusion.
- •Patients who have a Deep Brain Stimulation (DBS) system.
- •Patients who have an implanted active cardiac implant (e.g. pacemaker or defibrillator).
- •Patients who have any other implantable neuro-stimulator whose stimulus current pathway may overlap with that of the SPRINT System.
研究组 & 干预措施
Peripheral Nerve Stimulation
Peripheral nerve stimulation (PNS) is a procedure used to relieve chronic back pain by targeting the nerves responsible for transmitting pain signals from the back to the brain. It is a minimally invasive approach that aims to disrupt the pain signals and provide pain relief.
干预措施: Sprint PNS system (Device)
Radiofrequency Ablation
Radiofrequency ablation (RFA) is the current standard of care for facet joint pain. It is a minimally invasive procedure used to relieve chronic back or neck pain caused by issues with the small joints in the spine called facet joints.
干预措施: Radiofrequency Ablation (Procedure)
结局指标
主要结局
Multifidus muscle activity
时间窗: 12 months after pre-treatment measurement
Muscle contraction quantification via shear wave elastography
Multifidus muscle activity
时间窗: pre-treatment
Muscle contraction quantification via shear wave elastography
Multifidus muscle activity
时间窗: within two weeks of treatment completion
Muscle contraction quantification via shear wave elastography
次要结局
- Oswestry Disability Index(12 months after pre-treatment measurement)
- Pain Intensity(12 months after pre-treatment measurement)
- Isometric back strength(within two weeks of treatment completion)
- Pfirmmann grade(12 months after pre-treatment measurement)
- PROMIS-29 v2.0(12 months after pre-treatment measurement)
- isometric back strength(12 months after pre-treatment measurement)
- Functional Reach(12 months after pre-treatment measurement)
- Repetitive Trunk Rotation(12 months after pre-treatment measurement)
- Repeated Chair Stands(12 months after pre-treatment measurement)
- t2-relaxation time(12 months after pre-treatment measurement)
- 2-point dixon MRI(12 months after pre-treatment measurement)
- Pain Intensity(pre-treatment)
- Pain Intensity(within two weeks of treatment completion)
- Oswestry Disability Index(pre-treatment)
- Oswestry Disability Index(within two weeks of treatment completion)
- PROMIS-29 v2.0(pre-treatment)
- PROMIS-29 v2.0(within two weeks of treatment completion)
- isometric back strength(pre-treatment)
- Functional Reach(pre-treatment)
- Functional Reach(within two weeks of treatment completion)
- Repetitive Trunk Rotation(pre-treatment)
- Repetitive Trunk Rotation(within two weeks of treatment completion)
- Repeated Chair Stands(pre-treatment)
- Repeated Chair Stands(within two weeks of treatment completion)
- Pfirmmann grade(pre-treatment)
- Pfirmmann grade(within two weeks of treatment completion)
- t2-relaxation time(pre-treatment)
- t2-relaxation time(within two weeks of treatment completion)
- 2-point dixon MRI(pre-treatment)
- 2-point dixon MRI(within two weeks of treatment completion)
研究者
Daniel Cortes
Associate Professor
Penn State University