BACKGROUND CONTEXT: Plasma disc decompression (PDD) may present a successful treatment option when conservative care fails in patients with symptomatic contained lumbar disc herniation. This condition can be difficult to treat effectively and often responds poorly to conservative care.</P>PURPOSE: To compare the effectiveness of PDD to fluoroscopy-guided transforaminal epidural injections (TFEI) for treating symptomatic contained lumbar disc herniation.</P>STUDY DESIGN/ SETTING: Multi-center, prospective randomized controlled clinical trial.</P>PATIENT SAMPLE: Ninety patients (18-75 years old) who had radicular pain (visual analogue scale (VAS) score ≥50) associated with a single-level lumbar contained disc herniation on MR or CT imaging and had failed ≥1 epidural corticosteroid injection 3–24 weeks prior to enrollment.</P>OUTCOME MEASURES: VAS scores for leg and back pain, Oswestry Disability Index (ODI), SF-36 questionnaire, satisfaction with treatment questionnaire, and procedure-related adverse events.</P>METHODS: A priori sample size estimation, using a common standard deviation of 25 points on a 100-point VAS for pain and setting type I error rate at 5%, suggested that a sample size of 44 subjects in each group would have 80% power to detect a difference in means of 15 VAS points at 6 months after PDD. Patients were randomly assigned to receive PDD (n=46) or up to two
The Spine Journal – Elsevier
Published: Sep 1, 2008
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