Percutaneous Epidural Adhesiolysis Using Inflatable Balloon Catheter and Balloon-less Catheter in Central Lumbar Spinal Stenosis with Neurogenic Claudication: A Randomized Controlled Trial.

Abstract

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.