Ultra-micronized Palmitoylethanolamide Effects on Sleep-wake Rhythm and Neuropathic Pain Phenotypes in Patients with Carpal Tunnel Syndrome: An Open-label, Randomized Controlled Study

摘要

Background: Patients with carpal tunnel syndrome often suffer from fragmentary sleep.This study was designed to assess the effectiveness of treatment with ultramicronized palmitoylethanolamidein reducing pain intensity and improving quality of sleep in patients with neuropathic paindue to carpal tunnel syndrome.Methods: An open, controlled study was conducted on 42 patients awaiting carpal tunnel syndromesurgery, suffering from sleep disorders and painful symptoms and randomized into two groups. Onegroup received ultramicronized palmitoylethanolamide (600 mg twice daily) during the pre- and postsurgeryperiods, while the other group did not receive any treatment except surgical therapy. Theprimary outcome measure was sleep quality assessment by the Pittsburgh Sleep Quality Index, withsecondary outcome as painful symptomatology intensity evaluated by the Numeric Rating Scale.Results: At the end of the pre-surgery period (T1) there was a highly significant improvement(p<0.0001) in overall sleep quality with an increase of continuous sleep time and a reduction of sleeplatency and disturbances as well as a significant mitigation (p<0.0001) of painful symptoms in favor ofthe treated group.Conclusion: Disturbed sleep patterns are very common in patients suffering from neuropathic paindue to carpal tunnel syndrome. Our results, albeit preliminary, suggest that ultramicronized palmitoylethanolamideadministration favors a clear improvement of sleep quality, confirming a correlationbetween sleep disorders and pain intensity.