Water-Dispersible Palmitoylethanolamide (PEA) Supplementation for Functional Improvement in Adults With Chronic...

Background Chronic pain, including low back pain (LBP), represents a major global public health issue and significantly affects quality of life. Low back pain is a highly prevalent condition worldwide and remains a growing public health concern.​​​​​​ Current conventional management includes pharmacological approaches such as nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and muscle relaxants, as well as non-pharmacological interventions including physical therapy and physiotherapy. Nutraceuticals are increasingly used as an adjunctive strategy, particularly in patients intolerant to conventional pharmacological treatments or requiring long-term management. Although some evidence supports their potential benefit, the overall quality of clinical data remains heterogeneous, and further well-designed studies are needed to establish efficacy and optimal use. Among these, palmitoylethanolamide (PEA) and botanical extracts such as Acmella oleracea have been individually investigated; however, evidence regarding their combined use remains limited and insufficiently explored.  Methods This pilot, open-label clinical trial evaluated the effects of a novel nutraceutical combination containing PEA and Acmella oleracea extract in subjects with low back pain with sciatica over a 4-week period. Pain intensity was assessed using the Numeric Rating Scale (NRS), while pain characteristics were evaluated using the validated Douleur Neuropathique 4 (DN4) questionnaire. The impact on daily living activities, as well as safety and tolerability, was also investigated. Results Sixty participants were recruited. Baseline NRS score was 5.12±0.79 and showed a significant reduction as early as 3 days after supplementation, with continued improvement throughout the study period, reaching 1.65 ± 0.66 at the end of the study (p<0.001). DN4 scores also decreased significantly over time, with reductions observed across most neuropathic pain descriptors. Improvements in daily functioning were similarly significant. The nutraceutical combination was well tolerated, with no relevant adverse events reported. Conclusions Although preliminary, these findings suggest that the investigated nutraceutical combination may represent a safe and potentially effective approach with a relatively rapid onset of action for the management of chronic low back pain with neuropathic features, including sciatica. Further randomized, controlled studies are warranted to confirm these results and to better define the clinical role of this approach.