1. 2018;21;593-606Percutaneous Epidural Adhesiolysis Using Inflatable Balloon Catheter and Balloon-less Catheter in Central Lumbar Spinal Stenosis with Neurogenic Claudication: A Randomized Controlled Trial
   Randomized Trial
   Myong-Hwan Karm, MD, Seong-Soo Choi, MD, PhD, Doo-Hwan Kim, MD, Jun-Young Park, MD, Sukyung Lee, MD, Jin Kyu Park, MD, Young Joong Suh, MD, Jeong-Gil Leem, MD, PhD, and Jin Woo Shin, MD, PhD.

BACKGROUND: 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.

OBJECTIVES: 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.

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 pain management clinic.

METHODS: 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.

RESULTS: 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).

LIMITATIONS: The results may vary according to the definition of successful response. Follow-up loss in the present study seemed to be high.

CONCLUSION: 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).

KEY WORDS: Balloon decompression, central, chronic pain, epidural adhesiolysis, lumbar, percutaneous, radiculopathy, spinal stenosis