Department of Dental Anesthesiology, Seoul National University Dental Hospital, Seoul, Korea.
Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Pain Physician. 2018 Nov;21(6):593-606.
When conventional interventional procedures fail, percutaneous epidural adhesiolysis (PEA), which has moderate evidence for successful treatment of lumbar spinal stenosis (LSS), has been recommended over surgical treatments. In a previous study, we demonstrated the efficacy of a newly developed inflatable balloon catheter for overcoming the access limitations of pre-existing catheters for patients with severe stenosis or adhesions.
This study compared the treatment response of combined PEA with balloon decompression and PEA only in patients with central LSS over 6 months of follow-up.
This study used a randomized, single-blinded, active-controlled trial design.
This study took place in a single-center, academic, outpatient interventional pain management clinic.
This randomized controlled study included 60 patients with refractory central LSS who suffered from chronic lower back pain and/or lumbar radicular pain. Patients failed to maintain improvement for > 1 month with epidural steroid injection or PEA using a balloon-less catheter. Patients were randomly assigned to one of 2 interventions: balloon-less (n = 30) and inflatable balloon catheter (n = 30). The Numeric Rating Scale (NRS-11), Oswestry Disability Index (ODI), Global Perceived Effect of Satisfaction (GPES), and Medication Quantification Scale III were each measured at 1, 3, and 6 months after PEA.
There was a significant difference between groups in NRS-11 reduction ≥ 50% (or 4 points), ODI reduction ≥ 30% (or 10 points), GPES ≥ 6 and ≥ 4 points at 6 months, and NRS-11 reduction ≥ 50% (or 4 points) at 3 months after PEA (P < .03). The proportion of successful responders was higher in the balloon group than in the balloon-less group throughout the total follow-up period. Furthermore, there was a statistically significant difference between groups at 6 months after PEA (P = .035).
The results may vary according to the definition of successful response. Follow-up loss in the present study seemed to be high.
PEA using the inflatable balloon catheter leads to significant pain reduction and functional improvement compared to PEA using the balloon-less catheter in patients with central LSS.The study protocol was approved by our institutional review board (2012-0235), and written informed consent was obtained from all patients. The trial was registered with the Clinical Research Information Service (KCT 0002093).
Balloon decompression, central, chronic pain, epidural adhesiolysis, lumbar, percutaneous, radiculopathy, spinal stenosis.
当传统介入治疗失败时，经皮硬膜外松解术（PEA）已被推荐用于治疗腰椎狭窄症（LSS），其具有中度证据表明能成功治疗。在之前的研究中，我们证明了一种新开发的可膨胀球囊导管对于克服严重狭窄或粘连患者现有导管进入受限的有效性。
本研究比较了在 6 个月的随访中，联合球囊扩张的 PEA 与单纯 PEA 治疗中央型 LSS 的治疗反应。
本研究采用随机、单盲、主动对照试验设计。
本研究在一家单中心、学术性、门诊介入疼痛管理诊所进行。
这项随机对照研究纳入了 60 例难治性中央型 LSS 患者，这些患者患有慢性下腰痛和/或腰椎根性痛。硬膜外类固醇注射或使用无球囊导管的 PEA 未能使患者的改善持续>1 个月。患者被随机分配到以下 2 种干预措施之一：无球囊（n = 30）和可膨胀球囊导管（n = 30）。在 PEA 后 1、3 和 6 个月，分别采用数字评分量表（NRS-11）、Oswestry 残疾指数（ODI）、总体感知疗效满意度（GPES）和药物量化量表 III 进行测量。
PEA 后 6 个月时，两组间 NRS-11 降低≥50%（或 4 分）、ODI 降低≥30%（或 10 分）、GPES≥6 分和≥4 分，以及 PEA 后 3 个月时 NRS-11 降低≥50%（或 4 分），差异均有统计学意义（P<.03）。在整个随访期间，球囊组的成功应答者比例高于无球囊组。此外，PEA 后 6 个月时两组间差异有统计学意义（P =.035）。
结果可能因成功应答的定义而异。本研究的随访损失似乎较高。
与使用无球囊导管的 PEA 相比，在中央型 LSS 患者中使用可膨胀球囊导管的 PEA 可显著减轻疼痛并改善功能。本研究方案获得了我们机构审查委员会的批准（2012-0235），并获得了所有患者的书面知情同意。该试验已在临床研究信息服务（Clinical Research Information Service，KCT 0002093）注册。
球囊减压，中央，慢性疼痛，硬膜外松解术，腰椎，经皮，根性病变，椎管狭窄。
