Study to Investigate the Potential Pharmacological Effect of Oral Palmitoylethanolamide (PEA) Therapy in the Management of Low Back Pain (Neuropathic Pain): A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial
This clinical trial aims to evaluate the potential therapeutic effects of oral supplemental Palmitoylethanolamide (PEA) Phytosome® in managing neuropathic low back pain. The study will involve adult participants diagnosed with neuropathic pain according to established criteria. Eligible participants will be randomized into three groups to receive either PEA Phytosome® supplementation as two different doses or a placebo for a specified period. Data collection will include demographic information, baseline pain intensity, quality of life assessments, and functional outcomes. The primary endpoint will be the reduction in pain intensity, while secondary endpoints will include improvements in quality of life and functional capacity. Safety and tolerability of the supplement will also be assessed. This trial seeks to provide robust clinical evidence of the potential pharmacological effect of PEA's Phytosome® as a potential adjunctive treatment for neuropathic low back pain.
• Healthy adults, both Male or female aged ≥ 18 years and ≤ 80 years;
• Diagnosed with neuropathic lower back pain for at least 3 months, as confirmed by clinical evaluation and DN4 (neuropathic pain 4 questions) screening questionnaire with score ≥4.
• Pain intensity score ≥ 5 measured by NRS (Numerical Rating Scale) score, over the past week.
• Willingness to adhere to study protocol, including visits, assessments, and self-reporting of symptoms.
• Ability to provide informed consent and comply with study requirements.