Oral Versus Topical NSAIDs Combined with Lumbar Stabilization Exercises in Chronic Low Back Pain: A Randomized Controlled Trial

Abstract

Background: Chronic low back pain is a major cause of disability worldwide and often requires multimodal management that balances efficacy with long-term safety. Oral NSAIDs are widely used but are associated with systemic adverse effects, whereas topical NSAIDs may offer comparable analgesic benefit with better tolerability. Objective: To compare the effectiveness and safety of oral versus topical NSAIDs when combined with lumbar stabilization exercises in individuals with chronic low back pain. Methods: A parallel-group randomized controlled trial was conducted in 100 participants with non-specific chronic low back pain. Participants were allocated to oral NSAIDs plus lumbar stabilization exercises or topical diclofenac gel plus the same exercise program for six weeks. Pain intensity was assessed using the Numeric Pain Rating Scale, functional disability using the Oswestry Disability Index, and adverse events using a structured checklist. Data were analyzed using mixed ANOVA under intention-to-treat principles. Results: Both groups demonstrated significant improvement over time in pain and disability. NPRS decreased from 6.92 ± 1.31 to 2.71 ± 0.96 in the oral NSAID group and from 6.78 ± 1.42 to 2.94 ± 1.02 in the topical NSAID group, with no significant between-group difference at week 6 (p=0.089). ODI improved from 42.6 ± 8.9 to 22.8 ± 6.3 and from 41.8 ± 9.1 to 24.6 ± 6.9, respectively (p=0.11). Adverse events were more frequent with oral NSAIDs (38% vs 22%; p=0.041). Conclusion: Oral and topical NSAIDs provided comparable short-term clinical benefit when combined with lumbar stabilization exercises, but topical NSAIDs demonstrated superior safety.