REAL-WORLD EVIDENCE ON THE EFFICACY OF TRAMADOL/PARACETAMOL 75 MG/650 MG IN LOW BACK PAIN: A RETROSPECTIVE COMPARATIVE STUDY ON A PREVALENT MUSCULOSKELETAL DISORDER

Abstract

Introduction. Low back pain (LBP) is one of the leading causes of disability worldwide (1) and represents a major socioeconomic burden (2). Pharmacological management remains challenging because currently available analgesics are often limited by tolerability and safety concerns (3). Fixed-dose tramadol/paracetamol combinations may provide multimodal analgesia with improved tolerability through opioid-sparing effects.Methods. This retrospective comparative observational study evaluated the effectiveness and safety of a fixed-dose tramadol/paracetamol combination (75 mg/650 mg) in patients with moderate-to-severe LBP treated for 15 days in a real-world rehabilitation setting. 102 patients received tramadol/paracetamol, while 100 untreated patients served as controls. Pain intensity was assessed using the Numerical Rating Scale (NRS), functional disability with the Oswestry Disability Index (ODI), and patient satisfaction through a Likert scale. Adverse events, dropout rate, and minimum clinically important difference (MCID) were also analyzed.Results. Baseline pain intensity was moderate-to-severe in both groups (mean NRS: 6.76 vs 5.76). In the treatment group, NRS significantly decreased from 6.76±1.24 at baseline to 3.96±1.73 at day 7 and 0.78±1.24 at day 15, with significantly greater improvement versus controls (p