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.
Document Type
Article
Publication Date
12-19-2025
Publication Title
Spine (Phila Pa 1976)
Abstract
STUDY DESIGN: Prospective, randomized, double-blinded, multi-center trial; Level 1.
OBJECTIVE: Evaluate 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, subjects were randomized to surgery plus dual-polymer gel (Treatment) or surgery alone (Control). Primary endpoint was reduction in leg pain 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: 134 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, 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 versus 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: Addition of dual-polymer gel as an adjuvant to partial discectomy for treatment of severe pain reduced leg and back pain, as well as increased the proportion of subjects with best responses to surgery.
Recommended Citation
Fischgrund J, Musante D, Arnold P, Kim K, Deutsch H, Rhyne A, et al 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. Spine (Phila Pa 1976). 2025 Dec 19. doi: 10.1097/BRS.0000000000005587. Epub ahead of print. PMID: 41396210.
DOI
https://pubmed.ncbi.nlm.nih.gov/41396210/
ISSN
1528-1159
PubMed ID
41396210