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

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 10ml of saline) or the Meloxicam (M- group, n=40, receiving 10 mg in 10 ml saline). If the pain numeric rating score (NRS) at 24hours remained >50% of the pre-treatment 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 24hours 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 3months 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 8 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 3months follow-up.