Related Experiment Video
Updated: May 1, 2026
Author Spotlight: Advancements and Challenges in Surgical Treatments for Postamputation Pain
Published on: March 8, 2024
Effectiveness and Tolerability of a Moderate Dose of Tapentadol Prolonged Release for Managing Severe, Chronic Low
Ralf Baron1, Uwe Kern2, Matthias Müller3
1Division of Neurological Pain Research and Therapy, Department of Neurology University Hospital of Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Objective:
To evaluate the effectiveness and tolerability of tapentadol prolonged release (PR) for severe, chronic low back pain with a neuropathic component in a subpopulation that achieved adequate pain relief with tapentadol PR 300 mg/day in a randomized, double-blind, phase 3b study.
Methods:
Patients with painDETECT "unclear" or "positive" ratings and pain intensity ≥ 6 (11-point NRS-3 [average 3-day pain intensity]) were titrated to tapentadol PR 300 mg/day over 3 weeks. A subpopulation with pain intensity < 4 continued receiving tapentadol PR 300 mg/day during an 8-week, open-label continuation arm. For the primary study population, patients with ≥ 1-point decrease from baseline and pain intensity ≥ 4 were randomized to tapentadol PR 500 mg/day or tapentadol PR 300 mg/day plus pregabalin 300 mg/day during a concurrent 8-week, double-blind comparative period.
Results:
From baseline to end of titration and to final evaluation, significant improvements were observed in pain intensity (mean [SD] changes from baseline to: end of titration; - 5.3 [1.78]; final evaluation; - 5.2 [2.39]; both P < 0.0001), neuropathic pain symptoms, and quality-of-life measures in the open-label continuation arm, with greater improvements in this selected subpopulation than in either group in the primary study population. A favorable tolerability profile was observed, with incidences of all individual treatment-emergent adverse events ≤ 5.1% during the continuation period.
Conclusions:
A subpopulation of patients with low back pain with a neuropathic component responded very well to tapentadol PR 300 mg/day, with significant improvements in pain intensity, neuropathic pain-related symptoms, and quality of life. Further research is needed to identify factors associated with a very positive treatment response.
