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

Background: When conventional interventional procedures fail, percutaneous epiduraladhesiolysis (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 theefficacy of a newly developed inflatable balloon catheter for overcoming the access limitations ofpre-existing catheters for patients with severe stenosis or adhesions.Objectives: This study compared the treatment response of combined PEA with balloondecompression and PEA only in patients with central LSS over 6 months of follow-up.Study Design: This study used a randomized, single-blinded, active-controlled trial design.Setting: This study took place in a single-center, academic, outpatient interventional painmanagement clinic.Methods: This randomized controlled study included 60 patients with refractory central LSS whosuffered from chronic lower back pain and/or lumbar radicular pain. Patients failed to maintainimprovement 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 inflatableballoon 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 eachmeasured at 1, 3, and 6 months after PEA.Results: There was a significant difference between groups in NRS-11 reduction ≥ 50% (or 4points), ODI reduction ≥ 30% (or 10 points), GPES ≥ 6 and ≥ 4 points at 6 months, and NRS11 reduction ≥ 50% (or 4 points) at 3 months after PEA (P < .03). The proportion of successfulresponders was higher in the balloon group than in the balloon-less group throughout the totalfollow-up period. Furthermore, there was a statistically significant difference between groups at 6months after PEA (P = .035).Limitations: The results may vary according to the definition of successful response. Follow-uploss in the present study seemed to be high.Conclusion: PEA using the inflatable balloon catheter leads to significant pain reduction andfunctional improvement compared to PEA using the balloon-less catheter in patients with centralLSS.The study protocol was approved by our institutional review board (2012-0235), and writteninformed consent was obtained from all patients. The trial was registered with the Clinical ResearchInformation Service (KCT 0002093).Key words: Balloon decompression, central, chronic pain, epidural adhesiolysis, lumbar,percutaneous, radiculopathy, spinal stenosis