Plasma disc decompression for contained cervical disc herniation: a randomized, controlled trial

Abstract

Prospective case series studies have shown that plasma disc decompression (PDD) using the COBLATION SpineWand device (ArthroCare Corporation, Austin, TX) is effective for decompressing the disc nucleus in symptomatic contained cervical disc herniations. This prospective, randomized controlled clinical trial was conducted to evaluate the clinical outcomes of percutaneous PDD as compared to conservative care (CC) through 1 year. Patients (n = 115) had neck/arm pain >50 on the visual analog scale (VAS) pain scale and had failed at least 30 days of failed CC. Patients were randomly assigned to receive either PDD (n = 62) or CC (n = 58). Clinical outcome was determined by VAS pain score, neck disability index (NDI) score, and SF-36 health survey, collected at 6 weeks, 3 months, 6 months, and 1 year. The PDD group had significantly lower VAS pain scores at all follow-up time points (PDD vs. CC: 6 weeks, -46.87 +/- 2.71 vs. -15.26 +/- 1.97; 3 months, -53.16 +/- 2.74 vs. -30.45 +/- 2.59; 6 months, -56.22 +/- 2.63 vs. -40.26 +/- 2.56; 1 year, -65.73 +/- 2.24 vs. -36.45 +/- 2.86; GEE, P < 0.0001). PDD patients also had significant NDI score improvement over baseline when compared to CC patients at the 6 weeks (PDD vs. CC: -9.15 +/- 1.06 vs. -4.61 +/- 0.53, P < 0.0001) and 1 year (PDD vs. CC: -16.70 +/- 0.29 vs. -12.40 +/- 1.26, P = 0.005) follow-ups. PDD patients showed statistically significant improvement over baseline in SF-36 physical component summary scores when compared to CC patients at 6 weeks and 1 year (PDD vs. CC: 8.86 + 8.04 vs. 4.24 +/- 3.79, P = 0.0004; 17.64 +/- 10.37 vs. 10.50 +/- 10.6, P = 0.0003, respectively). In patients who had neck/arm pain due to a contained cervical disc herniation, PDD was associated with significantly better clinical outcomes than a CC regimen. At 1 year, CC patients appeared to suffer a "relapse, showing signs of decline in most measurements, whereas PDD patients showed continued stable improvement.

Figures

Fig. 1

Percentage of patients achieving minimal clinical important difference for VAS pain scores. At all time points, 80% or more PDD patients achieved had >25 reduction in VAS pain scores; the difference in percentage of patients achieving MCID for pain VAS scores was statistically significant between treatment groups at 6 weeks, 3 months, and 1 year

Fig. 2

Percentage of patients achieving minimal clinical important difference for NDI scores. The difference in percentage of patients achieving MCID for NDI scores was statistically significant between treatment groups at 1 year