Deer Timothy, Heros Robert, Scarfo Keith, Gilligan Christopher, Jameson Jessica, Pilitsis Julie G, Desai Mehul J, Panchalingam Thadchaigeni, Goates Scott, Benison Alexander M, Okaro Udoka, Falowski Steven
The Spine and Nerve Center of the Virginias, Charleston, WV, USA.
Spinal Diagnostics, Tualatin, OR, USA.
J Pain Res. 2025 Jun 7;18:2823-2838. doi: 10.2147/JPR.S486759. eCollection 2025.
To compare the healthcare utilization (HCU) and costs for passive recharge burst Spinal Cord Stimulation (SCS) and conventional medical management (CMM) cohorts in patients with chronic low back pain (LBP) to a matched real-world cohort of similar indication. The null hypothesis is that SCS is equally or less cost-effective than CMM in treating LBP.
DISTINCT is a prospective, multi-center, randomized study. Data was collected during in-clinic visits at baseline, one, three, and six months. The DISTINCT "completer cohort" included 79 DISTINCT SCS patients and 55 DISTINCT CMM patients who completed the six-month visit. An external real-world cohort (n = 71) with similar characteristics to DISTINCT CMM patients was identified from a claims database (Optum's de-identified Market Clarity Data). Accessed data included healthcare resource utilization (HCU), pain-related medication usage, pain scale, and quality of life. HCU data covered physical therapy, chiropractic therapy, massage therapy, occupational therapy, acupuncture, injection treatments, radiofrequency ablation procedures, and opioid and anticonvulsant usage.
The DISTINCT study demonstrated superior outcomes in pain relief, function, and other symptoms with SCS compared to CMM in the treatment of persistent (at least 6 months) low back pain. DISTINCT SCS patients utilized fewer healthcare resources and incurred lower costs than DISTINCT CMM patients. Real-world CMM patients exhibited higher utilization of certain therapies, suggesting potential pre-crossover bias. SCS resulted in significant cost savings and improved quality of life compared to CMM. Including device costs, cost-effectiveness could be achieved within 2.7 years based on DISTINCT data. The real-world CMM arm used more high-priced interventional therapies, suggesting a pre-crossover bias in the CMM cohort.
This analysis supports the long-term benefits and cost-effectiveness of SCS in managing chronic LBP compared to CMM.
比较慢性下腰痛（LBP）患者中，被动充电式脊髓刺激（SCS）和传统药物治疗（CMM）队列的医疗资源利用（HCU）及成本，与具有相似适应症的匹配真实世界队列进行对比。零假设是SCS在治疗LBP方面的成本效益与CMM相同或更低。
DISTINCT是一项前瞻性、多中心、随机研究。在基线、1个月、3个月和6个月的门诊就诊期间收集数据。DISTINCT“完成者队列”包括79名完成6个月随访的DISTINCT SCS患者和55名完成6个月随访的DISTINCT CMM患者。从索赔数据库（Optum的去识别化市场清晰度数据）中识别出一个与DISTINCT CMM患者具有相似特征的外部真实世界队列（n = 71）。获取的数据包括医疗资源利用（HCU）、疼痛相关药物使用情况、疼痛量表和生活质量。HCU数据涵盖物理治疗、脊椎按摩治疗、按摩疗法、职业治疗、针灸、注射治疗、射频消融手术以及阿片类药物和抗惊厥药物的使用情况。
DISTINCT研究表明，在治疗持续性（至少6个月）下腰痛方面，与CMM相比，SCS在疼痛缓解、功能和其他症状方面具有更好的效果。DISTINCT SCS患者比DISTINCT CMM患者使用的医疗资源更少，成本更低。真实世界的CMM患者对某些治疗的利用率更高，表明可能存在交叉前偏倚。与CMM相比，SCS显著节省了成本并改善了生活质量。根据DISTINCT数据，包括设备成本在内，在2.7年内可实现成本效益。真实世界的CMM组使用了更多高价介入治疗，表明CMM队列中存在交叉前偏倚。
该分析支持与CMM相比，SCS在管理慢性LBP方面的长期益处和成本效益。
