PMID- 17762286 OWN - NLM STAT- MEDLINE DCOM- 20071002 LR - 20131121 IS - 1528-1159 (Electronic) IS - 0362-2436 (Linking) VI - 32 IP - 17 DP - 2007 Aug 1 TI - Efficacy of epidural perineural injections with autologous conditioned serum for lumbar radicular compression: an investigator-initiated, prospective, double-blind, reference-controlled study. PG - 1803-8 AB - STUDY DESIGN: Prospective, double-blind, reference-controlled, investigator-initiated, single center. OBJECTIVE: To evaluate the efficacy of Autologous Conditioned Serum (ACS; Orthokine) for the treatment of lumbar radicular compression in comparison to triamcinolone. SUMMARY OF BACKGROUND DATA: Evidence from animal studies indicates that cytokines such as interleukin-1 play a decisive role in the pathophysiology of lumbar radiculopathy. ACS is enriched in the interleukin-1 receptor antagonist and other anti-inflammatory cytokines. METHODS: Thirty-two patients were treated by epidural perineural injections with ACS; 27 patients were treated with 5 mg triamcinolone and 25 patients with 10 mg triamcinolone. Treatment was applied once per week for 3 consecutive weeks and followed for 6 months. The Visual Analogue Scale (VAS) of low back pain was the primary outcome measure. The Oswestry Disability Index (ODI) was the secondary endpoint of the study. All statistical analyses were performed in an exploratory manner using SAS for Windows, version 8.2, on a personal computer. Descriptive statistics were calculated for the VAS and ODI by treatment group and time point. The data were submitted to a repeated-measurements analysis of variance with effects on treatment group, time, and treatment group-by-time interaction. RESULTS: Patients with lumbar back pain who were treated with ACS or the 2 triamcinolone concentrations showed a clinically remarkable and statistically significant reduction in pain and disability, as measured by patient administered outcome measurements. From Week 12 to the final evaluation at Week 22, injections with ACS showed a consistent pattern of superiority over both triamcinolone groups with regard to the VAS score for pain, but statistical significance was observed only at Week 22 in direct comparison to the triamcinolone 5 group. However, there was no statistically significant difference between the 2 triamcinolone dosages during the 6 months of the study. CONCLUSION: ACS is an encouraging treatment option for patients with unilateral lumbar radicular compression. The decrease in pain was pronounced, clinically remarkable, and potentially superior to steroid injection. FAU - Becker, Cordelia AU - Becker C AD - Department of Orthopaedic Surgery, St. Josef-Hospital, University of Bochum, Bochum, Germany. Cordelia.Becker@elis-stiftung.de FAU - Heidersdorf, Stefan AU - Heidersdorf S FAU - Drewlo, Sascha AU - Drewlo S FAU - de Rodriguez, Sonja Zirke AU - de Rodriguez SZ FAU - Kramer, Juergen AU - Kramer J FAU - Willburger, Roland Ernst AU - Willburger RE LA - eng PT - Journal Article PT - Randomized Controlled Trial PL - United States TA - Spine (Phila Pa 1976) JT - Spine JID - 7610646 RN - 0 (Anti-Inflammatory Agents) RN - 0 (Biological Products) RN - 0 (Interleukin 1 Receptor Antagonist Protein) RN - 1ZK20VI6TY (Triamcinolone) SB - IM EIN - Spine. 2007 Nov 15;32(24):table of contents. Dosage error in article text CIN - Spine (Phila Pa 1976). 2008 Mar 1;33(5):576. PMID: 18317206 MH - Adult MH - Aged MH - Aged, 80 and over MH - Anti-Inflammatory Agents/*administration & dosage MH - Biological Products/*administration & dosage MH - Disability Evaluation MH - Double-Blind Method MH - Female MH - Humans MH - Injections, Epidural MH - Interleukin 1 Receptor Antagonist Protein/*administration & dosage/biosynthesis MH - Low Back Pain/drug therapy/*etiology/therapy MH - Male MH - Middle Aged MH - Pain Measurement MH - Prospective Studies MH - Radiculopathy/complications/drug therapy/*therapy MH - Serum/*metabolism MH - Time Factors MH - Treatment Outcome MH - Triamcinolone/*administration & dosage EDAT- 2007/09/01 09:00 MHDA- 2007/10/03 09:00 CRDT- 2007/09/01 09:00 PHST- 2007/09/01 09:00 [pubmed] PHST- 2007/10/03 09:00 [medline] PHST- 2007/09/01 09:00 [entrez] AID - 00007632-200708010-00002 [pii] AID - 10.1097/BRS.0b013e3181076514 [doi] PST - ppublish SO - Spine (Phila Pa 1976). 2007 Aug 1;32(17):1803-8. doi: 10.1097/BRS.0b013e3181076514.