Effectiveness and Factors Associated with Epidural Decompression and Adhesiolysis Using a Balloon-Inflatable Catheter in Chronic Lumbar Spinal Stenosis: 1-Year Follow-Up.

Objectives: This study aimed to investigate the efficacy of the combined balloon decompression with a balloon-inflatable catheter (ZiNeu) in addition to conventional epidural adhesiolysis, and to identify factors that predict patient responses.

Study Design: An institutional single-armed prospective observational study.

Subjects: Chronic refractory lumbar spinal stenosis.

Methods: This study was performed in 61 patients with spinal stenosis who suffered from chronic (at least 3 months) lumbar radicular pain with or without lower back pain. Patients had failed to maintain improvement for more than 1 month with conventional epidural injection. The numeric rating scale (NRS) and Oswestry disability index (ODI) were each measured at 1, 3, 6, and 12 months after percutaneous epidural adhesiolysis and balloon decompression with a ZiNeu catheter.

Results: The percentage of successful responders was 72.1%, 60.7%, 57.4%, and 36.1% of patients at 1, 3, 6, and 12 months, respectively. A single combined treatment of percutaneous epidural adhesiolysis and balloon decompression with a ZiNeu catheter provided sufficient pain relief and functional improvement in patients with chronic refractory lumbar spinal stenosis, and the improvement was maintained for 12 months (P < 0.001). Multivariate logistic regression analysis showed that absence of diabetes independently predicted successful response at 12 months after percutaneous epidural decompression and adhesiolysis with the balloon catheter (Odds ratio = 0.080; 95% confidence interval = 0.009-0.676; P = 0.020).

Conclusions: The combined epidural adhesiolysis and balloon decompression with a ZiNeu catheter led to significant pain relief and functional improvement in a subset of patients with refractory spinal stenosis.