PMID- 16041194 OWN - NLM STAT- MEDLINE DCOM- 20060104 LR - 20220316 IS - 1075-2765 (Print) IS - 1075-2765 (Linking) VI - 12 IP - 4 DP - 2005 Jul-Aug TI - Lidocaine patch treatment in patients with low back pain: results of an open-label, nonrandomized pilot study. PG - 311-9 AB - This prospective, 6-week, multicenter, open-label, nonrandomized pilot study was designed to assess the effectiveness and safety of a lidocaine patch 5% in patients with low back pain (LBP). Patients with moderate to severe LBP, defined as acute/subacute (< 3 months, n = 21), short-term chronic (3-12 months, n = 33), or long-term chronic (> 12 months, n = 77), were recruited from 5 clinics; participants applied < or = 4 patches (560 cm total) once daily to area of maximal LBP as add-on treatment through week 2, with the option to taper concomitant analgesics during weeks 3-6. Scores on Brief Pain Inventory (BPI) were obtained at weeks 2 and 6. Safety analyses included reports of adverse events (AEs) and skin sensitivity to pinprick/light touch. Significant improvements in average daily pain intensity on the BPI were noted at weeks 2 and 6 (P < or = 0.001). Significant improvements in pain interference with quality of life (QOL) were noted for all BPI measures of QOL at weeks 2 and 6 for the acute/subacute (P < or = 0.007) and long-term chronic LBP groups (P < 0.0001) and for 5 of 7 BPI measures for the short-term chronic LBP group (P < or = 0.042). Fifty-eight percent of patients reported being "satisfied" or "very satisfied" with treatment. The lidocaine patch was well tolerated. Most common AEs were dizziness and rash (n = 5, 3.8%), and most AEs (80%) were mild to moderate in intensity. Significant improvement in pain intensity and QOL in this cohort of LBP patients was noted during treatment with the lidocaine patch 5%. Controlled clinical trials are warranted. FAU - Gimbel, Joseph AU - Gimbel J AD - Arizona Research Center, Phoenix, Arizona 85023, USA. regulatory@azresearchcenter.com FAU - Linn, Richard AU - Linn R FAU - Hale, Martin AU - Hale M FAU - Nicholson, Bruce AU - Nicholson B LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - United States TA - Am J Ther JT - American journal of therapeutics JID - 9441347 RN - 0 (Anesthetics, Local) RN - 98PI200987 (Lidocaine) SB - IM MH - Acute Disease MH - Administration, Cutaneous MH - Anesthetics, Local/administration & dosage/adverse effects/*therapeutic use MH - Chronic Disease MH - Female MH - Humans MH - Lidocaine/administration & dosage/adverse effects/*therapeutic use MH - Low Back Pain/*drug therapy MH - Male MH - Middle Aged MH - Pain Measurement MH - Pilot Projects MH - Quality of Life EDAT- 2005/07/26 09:00 MHDA- 2006/01/05 09:00 CRDT- 2005/07/26 09:00 PHST- 2005/07/26 09:00 [pubmed] PHST- 2006/01/05 09:00 [medline] PHST- 2005/07/26 09:00 [entrez] AID - 00045391-200507000-00006 [pii] AID - 10.1097/01.mjt.0000164828.57392.ba [doi] PST - ppublish SO - Am J Ther. 2005 Jul-Aug;12(4):311-9. doi: 10.1097/01.mjt.0000164828.57392.ba.