• Sven R Andresen, Jette Bing, Rikke M Hansen, Fin Biering-Sørensen, Inger L Johannesen, Ellen Merete Hagen, Andrew S C Rice, Jørgen F Nielsen, Flemming W Bach, and Nanna B Finnerup.
• aSpinal Cord Injury Centre of Western Denmark, Department of Neurology, Regional Hospital of Viborg, Viborg, Denmark bClinic for Spinal Cord Injuries, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark cDepartment of Clinical Medicine, University of Bergen, Bergen, Norway dThe Autonomic Unit, National Hospital for Neurology and Neurosurgery, University College London, Queen Square, United Kingdom ePain Research, Department of Surgery and Cancer, Imperial College, London, United Kingdom fHammel Neurorehabilitation and Research Centre, Hammel, Denmark gDepartment of Neurology, Aalborg University Hospital, Aalborg, Denmark hDanish Pain Research Center, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
• Pain. 2016 Sep 1; 157 (9): 2097-103.

AbstractNeuropathic pain and spasticity after spinal cord injury (SCI) represent significant problems. Palmitoylethanolamide (PEA), a fatty acid amide that is produced in many cells in the body, is thought to potentiate the action of endocannabinoids and to reduce pain and inflammation. This randomized, double-blind, placebo-controlled, parallel multicenter study was performed to investigate the effect of ultramicronized PEA (PEA-um) as add-on therapy on neuropathic pain in individuals with SCI. A pain diary was completed and questionnaires were completed before and after the 12-week treatment with either placebo or PEA-um. The primary outcome measure was the change in mean neuropathic pain intensity from the 1-week baseline period to the last week of treatment measured on a numeric rating scale ranging from 0 to 10. The primary efficacy analysis was the intention to treat (baseline observation carried forward). Secondary outcomes included a per protocol analysis and effects on spasticity, evoked pain, sleep problems, anxiety, depression, and global impression of change. We randomized 73 individuals with neuropathic pain due to SCI, of which 5 had a major protocol violation, and thus 68 were included in the primary analysis. There was no difference in mean pain intensity between PEA-um and placebo treatment (P = 0.46, mean reductions in pain scores 0.4 (-0.1 to 0.9) vs 0.7 (0.2-1.2); difference of means 0.3 (-0.4 to 0.9)). There was also no effect of PEA-um as add-on therapy on spasticity, insomnia, or psychological functioning. PEA was not associated with more adverse effects than placebo.

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