Palmitoylethanolamide in the Treatment of Failed Back Surgery Syndrome.

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 ( T 0 ) and after one ( T 1 ), two ( T 2 ), and three ( T 3 ) months.

RESULTS: After the first month with TDP + PGB treatment only, VAS score decreased significantly from 5.7 ± 0.12 at the time of enrollment ( T 0 ) to 4.3 ± 0.11 ( T 1 ) ( p < 0.0001); 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 ( T 2 ) and 1.7 ± 0.11 ( T 3 , end of treatment) ( p < 0.0001) 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.