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.

项目摘要 据估计，15%至40%的慢性背痛病例涉及小关节。射频消融 (RFA)内侧分支神经是一种广泛使用的治疗干预， 关节痛。然而，内侧分支神经也向多裂肌提供运动信号。所以一间 RFA的不可避免的后果是多裂肌的去神经支配。多裂肌横跨2至4个脊柱 水平，显著促进脊柱的主动节段稳定性。最近的报告显示，短- RFA后对多裂肌的长期不良反应，包括多裂肌萎缩和脂肪增加 浸润多裂肌功能障碍导致椎间盘的异常负荷和变形， 加速了治疗节段的椎间盘退变。患者也有2至5倍的风险增加发展 狭窄和其他退行性脊柱疾病或在RFA后5 - 10年内接受脊柱融合， 与其他腰痛患者相比。因此，尽管RFA在短期内是有益的，但它可能 使患者在未来更容易出现其他背痛机制。 最近批准的用于小关节疼痛的治疗是内侧分支的外周神经刺激（PNS）。在 在这种治疗中，在内侧神经附近植入1根或2根细导线，并连接到可穿戴式电 刺激器该系统能够连续40天向内侧神经输送电刺激。 在此期间之后，电线被移除。最近的一项研究表明，疼痛减轻70%，持续长达1年， 这与内侧神经的RFA相当。然而，PNS对多裂肌功能的影响 肌肉是已知的。由于内侧神经没有受损，可能是运动信号仍然激活了神经元。 多裂肌保留其部分或全部功能。如果多裂肌在PNS后仍保持功能， 也可以避免RFA后观察到的影响。因此，本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局和不良生物力学效应。的 研究分为两个目标。目的1是比较RFA和PNS的临床和性能结局。 目的2是量化和比较RFA和PNS的生物力学效应。 小关节疼痛的多裂保留治疗引起了极大的兴趣。多裂肌在 脊柱生物力学的作用。因此，多裂肌失神经支配可导致脊柱的其他机制 退化和背痛。从临床角度来看，PNS是RFA的一种有前途的替代方法。本研究将 不仅比较RFA和PNS之间的临床结局，而且还观察潜在的不良反应， 脊柱生物力学的一部分。如果PNS不影响多裂肌功能或增加脊柱退变的风险， 它可以极大地改变目前治疗小关节疼痛的方法。