BALTIMORE, MD — March 15, 2002 — New findings suggest that the new combination analgesic, tramadol/acetaminophen (37.5mg/325 mg) tablets, is an effective and safe treatment for chronic lower back pain.
Dr. Paul Peloso, with the University of Iowa in Iowa City presented the data here today at the 21st Annual Scientific Meeting of the American Pain Society (APS).
Following a three-week analgesic washout, 338 patients with at least moderate chronic lower back pain, pain visual analog (PVA) scale of 40 mm or more, for at least three months were randomized to tramadol/acetaminophen (APAP) or placebo for 91 days. The intent-to-treat population included 336 patients. The mean baseline PVA score was 67.8 mm.
Compared to placebo, the tramadol/APAP group had a significantly lower mean final PVA score (47.4 mm versus 62.9 mm). The mean final pain relief score was significantly higher in the tramadol/APAP group (1.8) than in the placebo group (0.7).
Mean improvements in the Short-Form McGill Pain Questionnaire scores were statistically better for the tramadol/APAP group compared to placebo for the Sensory Component, Total Score, and Present Pain Index measures. The improvement in the Affective Component score was not statistically significant.
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