Open AccessEffects of Transforaminal Balloon Treatment in Patients with Lumbar Foraminal Stenosis: A Randomized, Controlled, Double-Blind Trial
Author(s) -
Sung Hoon Kim,
Woo-Young Choi,
Jeong Hun Suh,
Sang Ryong Jeon,
Chang Ju Hwang,
Won Uk Koh,
Chung Lee,
Jeong Gil Leem,
Sang Chul Lee,
Jin Woo Shin
Publication year - 2013
Publication title -
pain physician
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.31
H-Index - 99
eISSN - 2150-1149
pISSN - 1533-3159
DOI - 10.36076/ppj.2013/16/213
Subject(s) - medicine , oswestry disability index , surgery , balloon , lumbar , neurogenic claudication , visual analogue scale , claudication , randomized controlled trial , lumbar spinal stenosis , back pain , spinal stenosis , anesthesia , low back pain , vascular disease , arterial disease , alternative medicine , pathology
Background: Lumbar spinal stenosis is a common condition in the elderly. Although balloontreatment is a well-known therapeutic method in specific pain conditions, applying the balloontreatment in patients with lumbar spinal stenosis is not yet well established.Objectives: We tested the therapeutic effect of transforaminal balloon treatment with a Fogarty ballooncatheter on body pain and functional performance in patients with severe lumbar spinal stenosis.Study Design: Prospective, randomized, double-blinded, active control trial.Setting: A tertiary, interventional pain management practice, specialty referral center.Methods: Sixty-two patients with refractory unilateral radiculopathy aggravated by walking wereenrolled and randomly assigned to receive transforaminal steroid injection after transforaminalballoon treatment using a 3 Fr balloon catheter (n = 32) or the same procedure without balloontreatment (n = 30). The patients were prohibited from making any alterations to their medicationsduring the 12 weeks of their follow-up period. After the first 12 weeks, the patients who hadpersistent symptoms or unbearable pain were allowed to increase the dose of analgesics or toreceive additional interventional treatment.Outcome Assessment: Visual analogue scale (VAS) pain scores for the leg and lower back,Oswestry disability index (ODI), and claudication distance were measured at 2, 4, 8, and 12 weekspost procedure. During the 52 weeks of the overall follow-up period, the patients achieving ≥ 50%leg pain relief without additional treatment or increasing the dose of analgesics were evaluated.Results: Significant improvement occurred compared to baseline in VAS (P < 0.001), ODI (P < 0.001),and claudication distance (P < 0.001) in the balloon group during the overall follow-up period, whereasthe improvement in ODI (P < 0.05) and claudication distance (P < 0.05) in the control group persistedfor 8 weeks. The balloon group showed better improvement in leg VAS (P < 0.05), ODI (P < 0.05),and claudication distance (P < 0.05) than the control group at all post-procedure assessment points.Kaplan-Meier analysis of the duration of the patients achieving ≥ 50% leg pain relief without additionaltreatment or increasing the dose of analgesics showed a significant intergroup difference between theballoon and control (P = 0.003) groups. Six patients (18.8%) in balloon group maintained > 50% painrelief for 52 weeks whereas no patient (0%) did in control group.Limitations: Our study is an active-controlled randomized design with a relatively small numberof patients.Conclusion: Transforaminal balloon treatment leads to both significant pain relief and functionalimprovement in a subset of patients with refractory spinal stenosis.Institutional Review: This study was approved by the Institutional Review Board of the AsanMedical Center.Key words: Neurogenic claudication, lumbar foraminal stenosis, transforaminal balloontreatment, Fogarty catheter