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Plasma disc decompression compared with fluoroscopy-guided transforaminal epidural steroid injections for symptomatic contained lumbar disc herniation: a prospective, randomized, controlled trial.
- Source :
-
Journal of neurosurgery. Spine [J Neurosurg Spine] 2010 Apr; Vol. 12 (4), pp. 357-71. - Publication Year :
- 2010
-
Abstract
- Object: Patients with radiculopathy, with or without back pain, often do not respond to conservative care and may be considered for epidural steroid injection therapy or a disc decompression procedure. Plasma disc decompression (PDD) using the Coblation SpineWand device is a percutaneous, minimally invasive interventional procedure. The purpose of this study was to evaluate clinical outcomes with PDD as compared with standard care using fluoroscopy-guided transforaminal epidural steroid injection (TFESI) over the course of 2 years.<br />Methods: This was a multicenter randomized controlled clinical study. Ninety patients (18-66 years old) who had sciatica (visual analog scale score > or = 50) associated with a single-level lumbar contained disc herniation were enrolled. In all cases, their condition was refractory to initial conservative care and 1 epidural steroid injection had failed. Participants were randomly assigned to receive either PDD (46 patients) or TFESI (44 patients, up to 2 injections).<br />Results: The patients in the PDD Group had significantly greater reduction in leg pain scores and significantly improved Oswestry Disability Index and 36-Item Short Form Health Survey ([SF-36], physical function, bodily pain, social function, and physical components summary) scores than those in the TFESI Group. During the 2-year follow-up, 25 (56%) of the patients in the PDD Group and 11 (28%) of those in the TFESI Group remained free from having a secondary procedure following the study procedure (log-rank p = 0.02). A significantly higher percentage of patients in the PDD Group showed minimum clinically important change in scores for leg and back pain and SF-36 scores that exceeded literature-based minimum clinically important changes. Procedure-related adverse events, including injection site pain, increased leg or back pain, weakness, and lightheadedness, were observed in 5 patients in the PDD Group (7 events) and 7 in the TFESI Group (14 events).<br />Conclusions: In study patients who had radicular pain associated with a contained lumbar disc herniation, those patients treated with PDD had significantly reduced pain and better quality of life scores than those treated using repeated TFESI. In addition, significantly more PDD patients than TFESI patients avoided having to undergo a secondary procedure during the 2-year study follow-up.
- Subjects :
- Adolescent
Adult
Aged
Back Pain etiology
Back Pain physiopathology
Fluoroscopy
Follow-Up Studies
Humans
Injections, Epidural adverse effects
Intervertebral Disc diagnostic imaging
Intervertebral Disc Displacement complications
Intervertebral Disc Displacement diagnostic imaging
Intervertebral Disc Displacement physiopathology
Leg
Middle Aged
Pain etiology
Pain physiopathology
Palliative Care
Quality of Life
Retreatment
Young Adult
Adrenal Cortex Hormones administration & dosage
Decompression, Surgical adverse effects
Intervertebral Disc surgery
Intervertebral Disc Displacement surgery
Lumbar Vertebrae surgery
Minimally Invasive Surgical Procedures
Subjects
Details
- Language :
- English
- ISSN :
- 1547-5646
- Volume :
- 12
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Journal of neurosurgery. Spine
- Publication Type :
- Academic Journal
- Accession number :
- 20201654
- Full Text :
- https://doi.org/10.3171/2009.10.SPINE09208