Background and aims To assess the efficacy and safety of palmitoylethanolamide(PEA) in reducing pain severity in patients with pain associated to failed back surgery syndrome (FBSS). This syndrome is not actually a syndrome — it is a very generalized term that is often used to describe the condition of patients who have not had a successful result with back surgery or spine surgery and have experienced continued pain after surgery. PEA is an endogenous fatty acid amide, inhibits the release of pro-inflammatory mediators from activated mast cells and reduces the recruitment and activation of mast cells at site of nerve injury, events associated with anti-allodynic and anti-hyperalgesic effects in a model of neuropathic pain.
Methods An observational study was carried out according to standard accepted procedures in clinical practice. 60 eligible patients over 60 years old received PEA twice a day for 4 weeks. PEA was added to their conventional analgesic therapy which included anticonvulsants, antiepileptics and opioids. NRS assessment was performed at baseline and at the end of PEA treatment. Safety was also evaluated.
Results PEA treatment significantly decreased the mean pain score evaluated in all patients who completed the study. PEA showed no adverse effects.
Conclusions In this study PEA was effective and safe in the management in chronic pain observed in FBSS.
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