Dual-Polymer Carboxymethyl Cellulose and Poly(Ethylene Oxide) Gel Reduces Leg and Back Pain in Patients With Severe Leg and Back Pain Following Single-Level Partial Discectomy.

STUDY

DESIGN

Prospective, randomized, double-blinded, multicenter trial.

OBJECTIVE

Evaluate the safety and effectiveness of Oxiplex (dual-polymer gel) as an adjuvant during single-level partial discectomy in patients with severe leg and back pain.

SUMMARY OF BACKGROUND DATA: Dual-polymer gel previously reduced leg and back pain after partial lumbar discectomy in a subgroup of patients with severe leg and back pain.

METHODS

Following single-level partial lumbar discectomy, participants were randomized to surgery plus dual-polymer gel (treatment) or surgery alone (control). The primary endpoint was the reduction in leg pain on the visual analog scale (VAS) at 6 months. Secondary outcomes were reductions in Sciatica Bothersomeness Index (SBI), back pain VAS, Oswestry Disability Index (ODI), SF-12 Mental (MCS) and Physical (PCS) Component Summaries, return to work, and patient satisfaction at 6-months.

RESULTS

One hundred thirty-four participants were randomized 2:1 [ITT cohort (N=134); n=87 Treatment; n=47 controls]. There were no clinical differences in safety or adverse events. Following removal of participants with protocol deviations, the Per Protocol cohort was N=102 (n=69 treatments; n=33 controls). Reductions in VAS leg pain, primary outcome measure, were not different (treatment -73.9; control -72.7). However, VAS Leg Pain improved by 100% for 33 of 68 treatments (5% increase vs. controls); ≥90% for 50 treatments (11% increase vs. controls). SBI decreased by 100% for 20 of 67 Treatments (11% increase vs. controls); SBI decreased by ≥90% for 33 treatments (24% increase vs. controls). SBI leg pain component decreased ≥80% in treatments vs. 66% of controls; P =0.039. More treatments achieved meaningful VAS back pain reduction (≥30%) than controls (93% vs. 88%). ODI decreased by 100% for 20 of 68 treats (13% increase vs. controls).

CONCLUSION

The addition of dual-polymer gel as an adjuvant to partial discectomy for the treatment of severe pain, reduced leg and back pain, as well as increased the proportion of participants with the best responses to surgery.

EVIDENCE OF LEVEL: Level I.