Oxiplex Reduces Leg Pain, Back Pain and Associated Symptoms Following Lumbar Discectomy.
Spine (Phila Pa 1976). 2011 Sep 2;
Authors: Rhyne AL, Blumenthal SL, Frank EH, Hsu KY, Kim KD, Youssef JA, Wang JC, Arnold P, Bendebba M, Block KM, Juarez TG, Chiacchierini RP, Ehmsen RJ, Krelle JS, Dizerega GS
ABSTRACT: Study Design. Prospective, randomized, blinded clinical trial.Objective. To evaluate effectiveness of Oxiplex gel for reduction of pain and associated symptoms following lumbar discectomy.Summary of Background Data. Oxiplex gel (carboxymethylcellulose, polyethylene oxide and calcium) is used during discectomy to coat the surgical site for reduction of pain and symptoms following lumbar discectomy.Methods. Patients undergoing single-level lumbar discectomy performed by laminectomy or laminotomy and randomized to receive either surgery plus Oxiplex gel (treatment group) or surgery alone (control group) were assessed 6 months following surgery using 1) a quality of life questionnaire (Lumbar Spine Outcomes Questionnaire: LSOQ) and 2) clinical evaluations.Results. There were no statistically significant differences in baseline demographics, surgical procedures, LSOQ scores and clinical evaluations between treatment (N = 177) and control (N = 175) groups. More gel-treated patients were satisfied with outcome of their surgical treatment than control patients (P = 0.05). The gel-treated group showed greater reductions in pain and symptoms from baseline compared to surgery-only controls. Additional benefits of gel were consistently shown in reduction of leg and back pain at 6 months in the patient population having substantial back pain at baseline (greater than or equal to the median LSOQ pain score of 63). In that population, there was a statistically significant reduction of leg pain and back pain (P<0.01) in the treatment group compared to controls. Fewer patients in the treatment group had abnormal musculoskeletal physical exams at 6 months compared to controls. There were no cases of CSF leaks and no differences in laboratory values or vital signs. Patients in the treatment group had less hypoaesthesias, paraesthesias, sensory loss and fewer re-operations during the 6-month follow-up than controls (1 vs. 6).Conclusion. These data demonstrate improvements in clinical outcomes resulting from use of Oxiplex gel in discectomy procedures for treatment of lumbar disc herniation.
PMID: 21897344 [PubMed – as supplied by publisher]