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Pain Research and Treatment
Volume 2017 (2017), Article ID 1486010, 6 pages
Research Article

Palmitoylethanolamide in the Treatment of Failed Back Surgery Syndrome

1Department of MESVA, School of Medicine, University of L’Aquila, L’Aquila, Italy
2Paolo Procacci Foundation, Rome, Italy
3Department of Internal Medicine, Rheumatology and Medical Pain Therapy, Perugia University School of Medicine, Terni, Italy
4Department of Neurosurgery, “Santa Maria” General Hospital, Terni, Italy

Correspondence should be addressed to Giustino Varrassi

Received 1 February 2017; Revised 7 April 2017; Accepted 16 May 2017; Published 10 August 2017

Academic Editor: Donald A. Simone

Copyright © 2017 Antonella Paladini et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Introduction. This observational study was designed to evaluate the efficacy of ultramicronized palmitoylethanolamide (um-PEA) (Normast®) administration, as add-on therapy for chronic pain, in the management of pain-resistant patients affected by failed back surgery syndrome. Methods. A total of 35 patients were treated with tapentadol (TPD) and pregabalin (PGB). One month after the start of standard treatment, um-PEA was added for the next two months. Pain was evaluated by the Visual Analogue Scale (VAS) at the time of enrollment () and after one (), two (), and three () months. Results. After the first month with TDP + PGB treatment only, VAS score decreased significantly from at the time of enrollment () to 4.3 ± 0.11 () (); however, it failed to provide significant subjective improvement in pain symptoms. Addition of um-PEA led to a further and significant decrease in pain intensity, reaching VAS scores of 2.7 ± 0.09 () and 1.7 ± 0.11 (, end of treatment) () without showing any side effects. Conclusions. This observational study provides evidence, albeit preliminary, for the efficacy and safety of um-PEA (Normast) as part of a multimodal therapeutic regimen in the treatment of pain-resistant patients suffering from failed back surgery syndrome.