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

D. Scaturro¹, P. Terrana², S. Peri², D. Trastulli³, R. Piazza³, M. Mangrella³, G. Letizia Mauro¹ | ¹Dipartimento Medicina di Precisione in Area Medica, Chirurgica e Critica, Università degli Studi di Palermo, Italy; ²Azienda Sanitaria Provinciale 6 Palermo, Italy; ³Italfarmaco SpA, Medical Affairs Department, Milan, Italy

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<0.001 for both time points). In the tramadol/paracetamol group functional disability improved from moderate at baseline (ODI: 37.48%) to minimal at day 15 (4.06%), whereas the control group maintained moderate disability levels (29.8%; p<0.001 between groups). MCID analysis showed that NRS MCID was reached in 92.8% patients in the treatment group and 45% patients in the control group (p < 0.001), while ODI MCID was reached in 90.7% treated patients and 52% control patients (p < 0.001). Moderate-to-high satisfaction was reported by 75.5% of treated patients. Adverse events occurred in 4.9% of patients, mainly nausea, drowsiness, and constipation, leading to treatment discontinuation in all affected cases.
Conclusions. In a real-world clinical setting, the tramadol/paracetamol fixed-dose combination (75 mg/650 mg) provided significant and clinically meaningful improvements in pain and functional disability in patients with LBP compared with the natural disease course. The favorable tolerability profile and high patient satisfaction support its role as an effective therapeutic option for short-term management of moderate-to-severe LBP.