Evaluation of peripheral nerve stimulation as an alternative to radiofrequency ablation for facet joint pain

周围神经刺激替代射频消融治疗小关节疼痛的评估

• 批准号: 10734693
• 负责人: Daniel Humberto Cortes Correales
• 金额: $ 51.42万
• 依托单位: PENNSYLVANIA STATE UNIVERSITY, THE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10734693
• 关键词: Acceleration; Adverse effects; Affect; Aftercare; Anesthesia procedures; Arthralgia; Atrophic; Back; Back Pain; Biomechanics; Clinical; Control Groups; Denervation; Electric Stimulation; Evaluation; Facet joint structure; Fatty acid glycerol esters; Functional disorder; Future; Gait speed; Hardness; Implant; Infiltration; Injections; Intervertebral disc structure; Low Back Pain; MRI Scans; Measures; Medial; Modulus; Motor; Muscle; Nerve; Nerve Block; Operative Surgical Procedures; Outcome; Pain; Patient Self-Report; Patients; Performance; Peripheral Nerve Stimulation; Play; Procedures; Production; Protocols documentation; Radiofrequency Interstitial Ablation; Reporting; Risk; Role; Rotation; Signal Transduction; Spinal; Spinal Fusion; Stenosis; System; Therapeutic Intervention; Therapeutic Uses; Tissues; Vertebral column; arm; chronic back pain; elastography; interest; intervertebral disk degeneration; novel; pain patient; pain reduction; pain relief; preservation; randomized, clinical trials; recruit; tissue mapping; ultrasound

Project Summary It is estimated that 15% to 40% of chronic back pain cases involve the facet joints. Radiofrequency ablation (RFA) of the medial branch nerve is a widely used therapeutic intervention that is very effective in reducing facet joint pain. However, the medial branch nerve also provides motor signals to the multifidus muscle. Therefore, an unavoidable consequence of RFA is denervation of the multifidus. The multifidus muscle spans 2 to 4 spine levels, contributing significantly to the active, segmental stability of the spine. Recent reports have shown short- term adverse effects on the multifidus muscle following RFA, including multifidus atrophy and increased fat infiltration. Multifidus dysfunction causes abnormal loading and deformations of the intervertebral disc, leading to accelerated disc degeneration at the treated level. Patients also have 2 to 5 times increased risk of developing stenosis and other degenerative spine conditions or receiving a spine fusion in the 5 to 10 years after RFA, compared to other low-back pain patients. Therefore, although RFA is beneficial in the short term, it may predispose patients to other mechanisms of back pain in the future. A recently approved treatment for facet joint pain is peripheral nerve stimulation (PNS) of the medial branch. In this treatment, 1 or 2 fine‐wire leads are implanted near the medial nerve and connected to a wearable electrical stimulator. The system enables continuous delivery of electrical stimulation to the medial nerves for 40 days. After this period, the wires are removed. A recent study showed pain reduction of 70% lasting for up to 1 year, which is comparable to RFA for the medial nerve. However, the effect of PNS on the function of the multifidus muscle is known. Since the medial nerve is not damaged, it may be possible that motors signals still activate the multifidus preserving part or all its functionality. If the multifidus retains it functionality after PNS, the adverse effects observed after RFA could also be avoided. Therefore, the objective of this randomized clinical trial is to compare clinical outcomes and adverse biomechanical effects between RFA and PNS for facet joint pain. The study is divided in two aims. Aim 1 is to compare clinical and performance outcomes between RFA and PNS. Aim 2 is to quantify and compare biomechanical effects of RFA and PNS. Multifidus-sparing treatments for facet joint pain are of great interest. The multifidus muscle plays an important role in spine biomechanics. Consequently, multifidus denervation can lead to other mechanisms of spine degeneration and back pain. PNS is a promising alternative to RFA from the clinical point of view. This study will not only compare clinical outcomes between RFA and PNS, but also look at potential adverse effects in terms of spine biomechanics. If PNS doesn’t affect the multifidus function or increases the risk of spine degeneration, it can greatly change the current approach for treatment of facet joint pain.

项目概要 据估计，15% 至 40% 的慢性背痛病例涉及小关节。 内侧支神经 (RFA) 是一种广泛使用的治疗干预措施，对于减少小关节面积非常有效 然而，内侧支神经也向多裂肌提供运动信号。 RFA 不可避免的后果是多裂肌的去神经支配 多裂肌跨越 2 至 4 个脊柱。 水平，对脊柱的主动、节段稳定性有显着贡献。最近的报告显示， RFA 后对多裂肌的长期不良影响，包括多裂肌萎缩和脂肪增加 多裂肌浸润功能障碍导致椎间盘的异常负载和变形，导致 在治疗水平上，患者发生椎间盘退变的风险也会增加 2 至 5 倍。 RFA 后 5 至 10 年内出现狭窄和其他脊柱退行性疾病或接受脊柱融合术， 因此，与其他腰痛患者相比，虽然 RFA 在短期内是有益的，但它可能会带来副作用。 使患者将来容易出现其他背痛机制。 最近批准的治疗小关节疼痛的方法是内侧分支的周围神经刺激（PNS）。 在这种治疗中，将 1 或 2 根细导线植入内侧神经附近，并连接到可穿戴电子设备 该系统能够连续向内侧神经提供 40 天的电刺激。 在此期间之后，移除金属丝，最近的一项研究表明，疼痛减轻了 70%，可持续长达 1 年。 这与内侧神经的 RFA 相当，但是 PNS 对多裂肌功能的影响。 由于内侧神经未受损，运动信号可能仍会激活肌肉。 如果多裂肌在 PNS 后保留其功能，则不利。 RFA 后观察到的影响也是可以避免的，因此，这项随机临床试验的目的是 比较 RFA 和 PNS 治疗小关节疼痛的临床结果和不良生物力学效应。 研究分为两个目的，目的 1 是比较 RFA 和 PNS 的临床和表现结果。 目标 2 是量化和比较 RFA 和 PNS 的生物力学效应。 多裂肌对于小关节疼痛的保留治疗非常重要。 经测试，多裂肌去神经可以导致脊柱的其他机制。 从临床角度来看，PNS 是 RFA 的一种有前景的替代方案。 不仅比较 RFA 和 PNS 的临床结果，而且还考虑潜在的不良反应 如果 PNS 不影响多裂肌功能或增加脊柱退化的风险， 它可以极大地改变目前治疗小关节疼痛的方法。