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STIMFIX™在经皮脊髓刺激试验中的锚定：一项多中心研究的中期分析。

STIMFIX™ anchoring in percutaneous spinal cord stimulation trials: interim analysis of a multicenter study.

作者信息

Green Maja, Narra Lakshmi, Dang Saurabh, Diep Jack, Patel Dipan, Lim Philip, Atallah Joseph, Chakravarthy Krishnan

机构信息

Clinical Research Organization, Solaris Research Institute Inc, Delaware, USA.

Jersey Shore University Medical Center, Neptune, NJ, USA.

出版信息

Pain Manag. 2025 Aug;15(8):477-489. doi: 10.1080/17581869.2025.2527576. Epub 2025 Jul 8.

DOI:10.1080/17581869.2025.2527576
PMID:40624980
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12320872/
Abstract

AIMS

Lead migration during percutaneous spinal cord stimulation (SCS) trials can undermine therapeutic efficacy. This study evaluates the effectiveness of the novel, noninvasive STIMFIX anchoring system in reducing lead migration compared to conventional anchoring techniques.

PATIENTS & METHODS: This interim analysis included two prospectively collected cohorts. Group 1 ( = 28) was a randomized, single-center trial comparing three anchoring methods: sutures ( = 9), adhesive tape ( = 10), and manufacturer-provided anchors ( = 9). Group 2 ( = 20) was a multicenter, open-label, non-randomized study using STIMFIX anchors. Lead migration was measured via standardized fluoroscopic imaging on Days 1 and 7.

RESULTS

Mean lead migration in Group 1 was 33.5 mm (manufacturer anchor), 29.4 mm (tape), and 21.1 mm (sutures), with no significant differences between groups ( = 0.404). Group 2 demonstrated an average lead migration of 19.5 mm with STIMFIX. No major adverse events were reported; one case of minor skin irritation resolved without intervention.

CONCLUSIONS

STIMFIX demonstrated reduced lead migration compared to conventional methods, with favorable safety and ease of application. These findings support its use as a promising advancement in SCS trial anchoring.

CLINICAL TRIAL REGISTRATION

www.clinicaltrials.gov identifier is NCT05651646.

摘要

目的

经皮脊髓刺激（SCS）试验期间的导线移位会削弱治疗效果。本研究评估了新型无创STIMFIX锚固系统与传统锚固技术相比在减少导线移位方面的有效性。

患者与方法

这项中期分析纳入了两个前瞻性收集的队列。第1组（n = 28）是一项随机、单中心试验，比较了三种锚固方法：缝线（n = 9）、胶带（n = 10）和制造商提供的锚定器（n = 9）。第2组（n = 20）是一项使用STIMFIX锚定器的多中心、开放标签、非随机研究。在第1天和第7天通过标准化荧光透视成像测量导线移位情况。

结果

第1组的平均导线移位为33.5毫米（制造商提供的锚定器）、29.4毫米（胶带）和21.1毫米（缝线），各组之间无显著差异（P = 0.404）。第2组使用STIMFIX时的平均导线移位为19.5毫米。未报告重大不良事件；1例轻度皮肤刺激未干预自行缓解。

结论

与传统方法相比，STIMFIX显示出导线移位减少，安全性良好且易于应用。这些发现支持将其作为SCS试验锚固方面一项有前景的进展加以应用。

临床试验注册

www.clinicaltrials.gov标识符为NCT05651646。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a842/12320872/4f8fcaefea7f/IPMT_A_2527576_F0005_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a842/12320872/94ee1f0a3f5c/IPMT_A_2527576_F0001_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a842/12320872/1cd4425c041a/IPMT_A_2527576_F0002_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a842/12320872/9e5870142bef/IPMT_A_2527576_F0003_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a842/12320872/6fd0066b1ef7/IPMT_A_2527576_F0004_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a842/12320872/4f8fcaefea7f/IPMT_A_2527576_F0005_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a842/12320872/94ee1f0a3f5c/IPMT_A_2527576_F0001_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a842/12320872/1cd4425c041a/IPMT_A_2527576_F0002_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a842/12320872/9e5870142bef/IPMT_A_2527576_F0003_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a842/12320872/6fd0066b1ef7/IPMT_A_2527576_F0004_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a842/12320872/4f8fcaefea7f/IPMT_A_2527576_F0005_B.jpg

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Radiographic lead migration in percutaneous spinal cord stimulator trials.经皮脊髓刺激器试验中的 X 射线引导线迁移。
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Neuromodulation. 2023 Jul;26(5):917-927. doi: 10.1016/j.neurom.2023.03.016. Epub 2023 May 17.
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Evidence-based consensus guidelines on patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain.脊髓刺激疗法治疗慢性非癌痛的患者选择和试验刺激的循证共识指南。
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