Background Mechanical low back pain (MLBP) is the most common form of musculoskeletal pain seen in the emergency care setting, and with the highest frequency of repeat consultation after one month. Tapentadol is a recently introduced opiate indicated for the control of intense chronic pain in adults.
Objectives To examine the usefulness of tapentadol versus conventional treatment with tramadol and/or nonsteroidal antiinflammatory drugs (NSAIDs) in terms of pain control and reduction of the number of hospital visits due to poor pain control or adverse events.
Methods A prospective observational study was conducted under conditions of routine clinical practice during 18 months in patients suffering MLBP with an associated neuropathic component. Each patient was controlled on a per protocol basis 7 days after first assessment. The study variables were: demographic characteristics, subjective pain score using a visual analogue scale (VAS), SF-36 general quality of life score, and the time at which repeat patient assessment was required for any reason, within the first 30 days after first care.
Results Data were collected from 591 patients. thirty-five patients received tapentadol at doses of 25-100 mg/day. The remaining 556 subjects were regarded as controls. Of these, 329 received tramadol: up to 37.5 mg/day (n=41); between 37.5 and less than 100 mg/day (n=111); between 100 and less than 200 mg/day (n=135); and ≥200 mg/day (n=42). 394 patients among those administered tramadol and tapentadol also received an NSAID. There were no statistically significant sex or race differences between the tapentadol and control groups. The proportion of patients with grade III (Kellgren-Lawrence) axial lumbar osteoarthritis was 82.9% in the tapentadol group and 22.5% among the controls (p=0.038). The change in VAS score after 7 days was significant in both groups (p<0.0001), though 68 of the controls showed an increased score, 112 showed no change in score, and 285 showed a decrease in pain score. In the tapentadol group, all the patients showed a decrease in VAS score, with the exception of a single patient who experienced no change. All the patients administered tapentadol showed a significant increase in SF-36 score (p<0.0001), while in the control group 36 patients showed an increase in score and 26 a decrease in score (p=0.324). Regarding the need for repeat consultation, a single patient in the tapentadol group and 52 patients in the control group had consulted within the first 7 days (p=0.353), versus 1 and 102, respectively, between days 8-14 (p=0.019), and 3 and 158 between days 15-30 (p=0.010). In the first 30 days, 47.8% of the controls had requested new medical evaluation (233 because of pain and 33 due to adverse effects), versus 14.3% in the tapentadol group (3 because of pain and 2 due to adverse effects) – the difference being statistically significant. None of the recorded adverse events required hospital admission.
Conclusions The use of tapentadol in patients presenting MLBP with a neuropathic component offers benefits in terms of short- and middle-term pain control, and a lessened need for emergency reassessment due to poor analgesia. Furthermore, the drug was not associated to an increased need for care due to adverse events in comparison with tramadol, NSAIDs or a combination of both.
Disclosure of Interest None declared
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