Methodological issues in conducting pilot trials in chronic pain as randomized, double-blind, placebo-controlled studies
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Peripheral neuropathy causes loss of sensation, numbness, and sometimes pain in the feet, legs, or hands due to nerve impairment caused by chronically high blood sugar and diabetes. In this study, methodological issues were investigated with respect to tapentadol extended release (ER) for managing chronic pain.
The efficacy of tapentadol extended release (ER) for managing chronic pain has been demonstrated in large-scale, randomized, controlled, phase 3 studies (N=318–1,030) in patients with chronic osteoarthritis (OA) pain, low back pain (LBP), and pain related to diabetic peripheral neuropathy (DPN), which led to registration in many regions, including the United States and Europe.