NCT06694337

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Liaquat University of Medical & Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Neuropathic low back pain arises from nerve damage or dysfunction, leading to chronic pain characterized by burning, tingling, or shooting sensations. This condition significantly impacts quality of life and is often refractory to conventional treatments. Palmitoylethanolamide (PEA) is an endogenous lipid mediator known for its anti-inflammatory, analgesic, and neuroprotective properties. PEA exerts its effects by modulating the endocannabinoid system and reducing the activation of mast cells and glial cells, which play a crucial role in chronic pain mechanisms. Its potential as a therapeutic agent for neuropathic pain has been demonstrated in preclinical and clinical studies, making it a promising candidate for managing neuropathic low back pain. In the present randomized, double-blind, placebo-controlled, parallel-group clinical trial, the investigators aim to evaluate the therapeutic effect of a novel bioavailable oral formulation of PEA's Phytosome® in the management of neuropathic low back pain in healthy adult population.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	300 mg Palmitoylethanolamide (PEA) Phytosome®	Oral supplement intake
DIETARY_SUPPLEMENT	450 mg Palmitoylethanolamide (PEA) Phytosome®	Oral supplement intake
OTHER	Control group	Placebo

Timeline

• Start date: 2025-01-28
• Primary completion: 2025-06-15
• Completion: 2025-06-23
• First posted: 2024-11-19
• Last updated: 2025-11-18

Locations

1 site across 1 country: Pakistan