EFFICACY AND SAFETY OF A FIXED-DOSE COMBINATION OF TRAMADOL/PARACETAMOL 75 MG/650 MG IN REDUCING PAIN INTENSITY IN PATIENTS WITH LOW BACK PAIN: A REAL-WORLD RETROSPECTIVE STUDY

D. Scaturro¹, P. Terrana², S. Peri², N. Palombi³, R. Piazza³, M. Mangrella³, G. Letizia Mauro¹ | ¹Department of Precision Medicine in the Medical, Surgical and Critical Care Area, University of Palermo; ²Functional Recovery and Rehabilitation, Hospital “St. Cimino” of Termini Imerese; ³Italfarmaco SpA, Medical Affairs Department, Milan

INTRODUCTION
Low back pain (LBP) is a complex and multifactorial condition affecting a substantial portion of the population.¹ Prevalence estimates suggest that up to 80% of adults will experience at least one episode of LBP during their lifetime.² One promising approach for LBP management is the use of combination therapies, which allow for lower dosages of each active ingredient, potentially reducing the risk of side effects.³ Tramadol/paracetamol combinations have been used in clinical practice to manage various pain conditions.^4-6 The multimodal action of tramadol, combining opioid and monoaminergic mechanisms, and paracetamol, an analgesic with minimal cyclooxygenase inhibitory activity, results in a comprehensive effect on pain by targeting both nociceptive and neuropathic components.⁷ This study aimed to assess the effectiveness and safety of a fixed-dose tramadol/paracetamol combination (75 mg/650 mg) for LBP management.
METHODS
In this real-world retrospective study, 100 adults with moderate-to-severe LBP were treated with tramadol/paracetamol over 15 days. Pain intensity through the NRS (Numeric Rating Scale), disability level through the ODI (Oswestry Disability Index) and patient satisfaction through a 4-point Likert scale, alongside the frequency and types of adverse events and dropout rate, were assessed.
RESULTS
A significant reduction in pain intensity, as measured by the NRS, was observed at T1 (day 7), with mean scores decreasing from 6.76 at baseline to 2.66 (p ≤ 0.05). This reduction was maintained at T2 (day 15), with a mean score of 2.35 (p ≤ 0.05) (Figure 1). The ODI improved from 37.5 at baseline to 4.06 at T2 (day 15) (p≤0.05) (Figure 1). Patient satisfaction on day 15 was moderate, with a score of 1.96 on a 4-point Likert scale. Adverse events, primarily nausea and constipation, were reported by 5% of patients. The dropout rate was also 5%, and in all cases, it was due to adverse events and not treatment inefficacy.
CONCLUSIONS
Tramadol/paracetamol (75 mg/650 mg) effectively reduced LBP intensity and led to improvements in functional disability with manageable adverse events. Although further studies are needed to confirm these findings in larger populations, the results indicate the key role of this combination to improve the quality of life of patients and the potential in reducing productivity loss and healthcare costs.