Study to Investigate the Potential Pharmacological Effect of Oral Palmitoylethanolamide (PEA) Therapy in the Management of Low Back Pain (Neuropathic Pain)

Inclusion Criteria:

• 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 byclinical evaluation and DN4 (neuropathic pain 4 questions) screening questionnairewith score ≥4.

• Pain intensity score ≥ 5 measured by NRS (Numerical Rating Scale) score, over thepast week.

• Willingness to adhere to study protocol, including visits, assessments, andself-reporting of symptoms.

• Ability to provide informed consent and comply with study requirements.

Exclusion Criteria:

• Known intolerance or allergy to any component of the tested nutraceuticals

• Presence of acute systemic disease

• Presence of significant organic pathology

• Current or past history of alcohol or drug abuse

• History of malignancy within the past 5 years

• Any significant concomitant disease or clinical condition that could compromiseparticipant safety or interfere with study completion

• Women of childbearing potential not using reliable contraceptive methods

• Pregnancy or breastfeeding

• Severe psychiatric disorders (e.g., major depression, schizophrenia) that couldaffect pain perception or adherence.

• Inability to adhere to the study requirements due to lifestyle, transportation, orcognitive impairment.

• Use of other cannabinoid-based therapies, investigational drugs, or concurrentparticipation in another clinical trial.

• Dependence on opioid analgesics or recent opioid use that may interfere with painassessment.

• Current use of other supplements with potential anti-inflammatory or analgesiceffects, including Omega-3 Fatty Acids, Turmeric/Curcumin, Glucosamine andChondroitin, Boswellia Serrata, Methylsulfonylmethane.