Lindley David, Anders Adrianna
Norman J. Dozier Pain Management, Abilene, Texas.
Pain Physician. 2024 Nov;27(8):E937-E942.
Low back pain is a highly prevalent condition with substantial costs. Superior cluneal neuralgia is present in up to 14% of low back pain cases. This etiology of back pain is often overlooked because the symptoms of superior cluneal neuralgia manifest similarly to those of other conditions, such as radiculopathy and sacroiliac joint pain. Peripheral nerve stimulation (PNS) is an emerging pain management modality used to treat various chronic pain conditions. This retrospective study will examine the outcomes of patients who have back pain caused by neuralgia and are treated with the permanent Freedom® PNS System (Curonix LLC) at the superior cluneal nerve.
The primary objective was to examine the responder rate (proportion of patients who experienced greater than 50% relief) and changes in pain scores after the trial procedure. Secondary objectives included changes in pain scores from at least one month after permanent implantation, adverse event occurrences, changes in function and quality of life, and reductions in medication usage.
This was a retrospective single-site study. All procedures were performed by the same interventional pain physician.
A retrospective chart review was conducted to assess baseline and follow-up parameters. Inclusion criteria consisted of requirements that patients be 18 years or older and have a confirmed superior cluneal neuralgia diagnosis responsible for their pain presentation. Exclusion criteria included the presence of another active implanted device for pain management. The 11-point verbal rating scale (VRS) was used to assess pain scores.
Twenty-one patients were included in this study. All 21 responded to the trial procedure with a 77% average reduction in VRS scores. At the follow-up (mean = 11 months), 20 patients reported an average 57% reduction in pain scores with the verbal rating scale. The same proportion of patients reported improved function and quality of life. Five patients reported reduced medication usage, including one who stopped taking pain medication altogether. No complications were reported.
We were limited to the data available in the patient charts since this was a retrospective study investigating the efficacy and safety of the Freedom® PNS System for patients with refractory chronic back pain.
When used to target the superior cluneal nerve, the Curonix Freedom® PNS System is an effective and safe treatment for neuralgia-caused chronic lower back pain resistant to conservative therapy.
下腰痛是一种极为常见的疾病，代价高昂。臀上皮神经痛在高达14%的下腰痛病例中存在。这种背痛病因常被忽视，因为臀上皮神经痛的症状与其他病症（如神经根病和骶髂关节疼痛）的症状相似。周围神经刺激（PNS）是一种新兴的疼痛管理方式，用于治疗各种慢性疼痛病症。这项回顾性研究将考察因神经痛导致背痛并接受永久性Freedom® PNS系统（Curonix LLC公司）治疗臀上皮神经的患者的治疗结果。
主要目的是考察试验程序后的反应率（疼痛缓解超过50%的患者比例）和疼痛评分变化。次要目的包括永久性植入后至少一个月的疼痛评分变化、不良事件发生情况、功能和生活质量变化以及药物使用减少情况。
这是一项回顾性单中心研究。所有手术均由同一位介入疼痛科医生进行。
进行回顾性病历审查以评估基线和随访参数。纳入标准包括患者年龄在18岁及以上且确诊臀上皮神经痛是其疼痛表现的病因。排除标准包括存在另一种用于疼痛管理的有源植入装置。采用11点数字评定量表（VRS）评估疼痛评分。
本研究纳入21例患者。所有21例患者对试验程序均有反应，VRS评分平均降低77%。在随访时（平均 = 11个月），20例患者报告使用数字评定量表时疼痛评分平均降低57%。相同比例的患者报告功能和生活质量有所改善。5例患者报告药物使用减少，其中1例完全停止服用止痛药。未报告并发症。
由于这是一项研究Freedom® PNS系统对难治性慢性背痛患者疗效和安全性的回顾性研究，我们受限于患者病历中的可用数据。
当用于靶向臀上皮神经时，Curonix Freedom® PNS系统是一种治疗对保守治疗耐药的神经痛引起的慢性下腰痛的有效且安全的方法。
