title: Reduction of Leg Pain by Oxiplex Gel After Lumbar Discectomy in Patients With Predominant Leg Pain and Elevated Levels of Lower Back Pain: A Prospective, Randomized, Blinded, Multicenter Clinical Study.
abstract: METHODS
  A prospective, randomized, blinded, multicenter clinical study.
  
  
  OBJECTIVE
  To evaluate carboxymethylcellulose/polyethylene oxide gel (Oxiplex) in improving clinical outcomes in subjects having predominant leg pain and elevated low back pain undergoing first-time lumbar discectomy for disk herniation.
  
  
  BACKGROUND
  Clinical studies in the United States and Italy found that Oxiplex reduced leg pain after decompression surgery.
  
  
  METHODS
  A total of 68 subjects with herniated lumbar disk were enrolled and randomized into treatment (surgery plus gel) or surgery-only control groups. A prospective statistical analysis assessed the effect of gel in the severe back pain subgroup (prespecified as greater than or equal to median baseline back pain of the population studied). All subjects except 2 controls lost to follow-up completed the study. Preoperative and postoperative visual analogue scale leg pain scores were analyzed and compared between groups at 60 days after surgery.
  
  
  RESULTS
  There were no serious adverse events or neurological safety concerns reported in any patients. Gel-treated patients had statistically significantly lower visual analogue scale leg pain scores at study end compared with controls (P=0.0240), representing a 21% additional reduction in leg pain compared with surgery alone in the severe baseline back pain subgroup (P=0.0240). The proportion of subgroup patients experiencing zero leg pain at study end was significantly higher in the gel treatment group (60%) than in the control group (23%) (P=0.0411).
  
  
  CONCLUSIONS
  The data from this study confirm and extend results of 2 previous studies in Italy and the United States that reported statistically significantly greater reductions in leg pain in gel-treated patients with severe preoperative low back pain compared with patients who only underwent decompression surgery.
authors.affiliation: *Institute of Orthopaedics, Xijing Hospital, The Fourth Military Medical University, Xi'an, Shanxi, People's Republic of China †FzioMed Inc., San Luis Obispo, CA ‡R.P. Chiacchierini & Associates, LLC, Rockville, MD §Livingston Research Laboratory, University of Southern California, Los Angeles, CA.
authors.forename: Wei
authors.initials: W
authors.lastname: Lei
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Ehmsen
authors.forename: Richard P
authors.initials: RP
authors.lastname: Chiacchierini
authors.forename: John L
authors.initials: JL
authors.lastname: Krelle
authors.forename: Gere S
authors.initials: GS
authors.lastname: diZerega
mesh_terms: D000328:Adult; D002482:Cellulose / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D017586:Diskectomy / Q000009:adverse effects*; D023381:Endpoint Determination; D005260:Female; D005782:Gels / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007866:Leg / Q000473:pathology*; D017116:Low Back Pain / Q000209:etiology / Q000628:therapy*; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D010149:Postoperative Pain / Q000209:etiology* / Q000628:therapy*; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D005782:Gels; C406630:Oxiplex; D011092:Polyethylene Glycols; D002482:Cellulose