Plasma disc decompression compared with fluoroscopy-guided transforaminal epidural steroid injections for symptomatic contained lumbar disc herniation: a prospective, randomized, controlled trial

Clinical article

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  • 1 Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania;
  • | 2 Stanford Interventional Spine Center, Stanford University, Redwood City;
  • | 9 Division of Biostatistics, Stanford University, Stanford;
  • | 8 Santa Rosa, California;
  • | 3 Massachusetts General Hospital,
  • | 4 Harvard Medical School, and
  • | 5 Beth Israel Deaconess Medical Center, Boston, Massachusetts;
  • | 6 OrthoCarolina, Charlotte, North Carolina; and
  • | 7 Innovative Spine Care, Little Rock, Arkansas
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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.

Methods

This was a multicenter randomized controlled clinical study. Ninety patients (18–66 years old) who had sciatica (visual analog scale score ≥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).

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).

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.

Abbreviations used in this paper:

APLD = automated percutaneous lumbar discectomy; BMI = body mass index; GEE = generalized estimating equations; ITT = intent-to-treat; MCID = minimum clinically important difference; ODI = Oswestry Disability Index; PDD = plasma disc decompression; SF-36 = 36-Item Short Form Health Survey; TFESI = transforaminal epidural steroid injection; VAS = visual analog scale.

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