Oxiplex reduces leg pain, back pain, and associated symptoms after lumbar discectomy

Alfred L. Rhyne, Scott L. Blumenthal, Edmund H. Frank, Ken Y. Hsu, Kee D Kim, Jim A. Youssef, Jeffrey C. Wang, Paul Arnold, Mohammed Bendebba, Kathleen M. Block, Thomas G. Juarez, Richard P. Chiacchierini, Ronald J. Ehmsen, John S. Krelle, Gere S. Dizerega

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Study Design.: Prospective, randomized, blinded clinical trial. Objective.: To evaluate effectiveness of Oxiplex gel for reduction of pain and associated symptoms after 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 after 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 after 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 with 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 with controls. Fewer patients in the treatment group had abnormal musculoskeletal physical examinations at 6 months compared with controls. There were no cases of cerebrospinal fluid leaks and no differences in laboratory values or vital signs. Patients in the treatment group had less hypoesthesia, paraesthesia, sensory loss, and fewer reoperations during the 6-month follow-up than controls (1 vs. 6). Conclusion.: These data demonstrate improvements in clinical outcomes resulting from the use of Oxiplex gel in discectomy procedures for treatment of lumbar disc herniation.

Original languageEnglish (US)
Pages (from-to)631-641
Number of pages11
JournalSpine
Volume37
Issue number8
DOIs
StatePublished - Apr 15 2012

Fingerprint

Diskectomy
Back Pain
Leg
Gels
Pain
Spine
Laminectomy
Therapeutics
Carboxymethylcellulose Sodium
Hypesthesia
Vital Signs
Paresthesia
Oxiplex
Reoperation
Population
Physical Examination
Randomized Controlled Trials
Quality of Life
Demography
Calcium

Keywords

  • back pain
  • discectomy
  • herniated disc
  • laminectomy
  • laminotomy
  • leg pain
  • Lumbar Spine Outcomes Questionnaire
  • Oxiplex

ASJC Scopus subject areas

  • Clinical Neurology
  • Orthopedics and Sports Medicine

Cite this

Rhyne, A. L., Blumenthal, S. L., Frank, E. H., Hsu, K. Y., Kim, K. D., Youssef, J. A., ... Dizerega, G. S. (2012). Oxiplex reduces leg pain, back pain, and associated symptoms after lumbar discectomy. Spine, 37(8), 631-641. https://doi.org/10.1097/BRS.0b013e3182309af7

Oxiplex reduces leg pain, back pain, and associated symptoms after lumbar discectomy. / Rhyne, Alfred L.; Blumenthal, Scott L.; Frank, Edmund H.; Hsu, Ken Y.; Kim, Kee D; Youssef, Jim A.; Wang, Jeffrey C.; Arnold, Paul; Bendebba, Mohammed; Block, Kathleen M.; Juarez, Thomas G.; Chiacchierini, Richard P.; Ehmsen, Ronald J.; Krelle, John S.; Dizerega, Gere S.

In: Spine, Vol. 37, No. 8, 15.04.2012, p. 631-641.

Research output: Contribution to journalArticle

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 2012, 'Oxiplex reduces leg pain, back pain, and associated symptoms after lumbar discectomy', Spine, vol. 37, no. 8, pp. 631-641. https://doi.org/10.1097/BRS.0b013e3182309af7
Rhyne, Alfred L. ; Blumenthal, Scott L. ; Frank, Edmund H. ; Hsu, Ken Y. ; Kim, Kee D ; Youssef, Jim A. ; Wang, Jeffrey C. ; Arnold, Paul ; Bendebba, Mohammed ; Block, Kathleen M. ; Juarez, Thomas G. ; Chiacchierini, Richard P. ; Ehmsen, Ronald J. ; Krelle, John S. ; Dizerega, Gere S. / Oxiplex reduces leg pain, back pain, and associated symptoms after lumbar discectomy. In: Spine. 2012 ; Vol. 37, No. 8. pp. 631-641.
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AU - Kim, Kee D

AU - Youssef, Jim A.

AU - Wang, Jeffrey C.

AU - Arnold, Paul

AU - Bendebba, Mohammed

AU - Block, Kathleen M.

AU - Juarez, Thomas G.

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