Treatment of recent onset low back pain with periradicular injections of meloxicam: a randomized, double blind, placebo controlled cross-over study

Abstract

Background: Low back pain (LBP) is a common and costly illness. This randomized, double-blind, placebo-controlled, cross-over study tested the hypothesis that periradicular injections of meloxicam would reduce LBP and improve physical activity compared to a saline injection at 3 months follow-up.

Methods: After IRB approval, 80 consenting patients suffering LBP of <6 months duration were randomly assigned to the control (C-group, N.=40, receiving 10 mL of saline) or the meloxicam (M-group, N.=40, receiving 10 mg in 10 mL saline). If the pain Numeric Rating Score (NRS) at 24 hours remained >50% of the pretreatment score, the patient was crossed-over to the other group. A successful treatment was NRS<3 at 3 months follow-up. Secondary outcome measures which were assessed included work-absence, physical-assistance, physical-activities limitations and pain-related insomnia.

Results: The baseline NRS was 9.3 (95% CI: 8.9-9.7) in the C-group and 9.2 (95% CI: 8.8-9.6) in the M-group. At the 24 hours follow-up after the initial treatment, the mean NRS was 6.3 (95% CI: 5.4-7.2) in the C-group vs. 3.5 (95% CI: 2.6-4.4) in the M-group (P<0.05). The number of cross-over cases was significantly higher in the C-group (N.=31, 77.5% vs. N.=5, 12.5%, P<0.001). At the 3 months follow-up, 66 patients (35+31) were allocated in the M-group and 54 (82%) reported NRS Score <3, while only 14 (9+5) patients remained in the C-group and eight patients had NRS<3.

Conclusions: Periradicular injection of meloxicam is an effective analgesic treatment for acute/subacute LBP. This novel use of meloxicam also leads to an improvement in the level of physical activity at the 3-month follow-up.