Using palmitoylethanolamide to treat chronic inflammatory pain
Randomized Placebo-Controlled Trial of Palmitoylethanolamide for Chronic Inflammatory Pain Conditions
This study is testing if a natural supplement called palmitoylethanolamide can help people with chronic inflammatory pain feel better and improve their daily function.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Sex | All |
| Sponsor | Navy Medical Center San Diego Federal |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06273462 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of palmitoylethanolamide (PEA), a naturally occurring supplement, in reducing pain and improving function in patients with chronic inflammatory pain conditions. Participants will be randomly assigned to receive either PEA or a placebo for a duration of 8 weeks. The study focuses on conditions such as rheumatoid arthritis, fibromyalgia, and neuropathic pain syndromes, which often do not respond well to conventional pain management strategies. By investigating PEA's potential anti-inflammatory properties, the trial seeks to provide insights into alternative therapeutic options for chronic pain management.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals experiencing chronic inflammatory pain for over three months with a pain intensity of 5/10 or greater who have not found relief from other conservative therapies.
Not a fit: Patients with severe allergies to specific food components such as nuts, eggs, or soy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new, effective treatment option for patients suffering from chronic inflammatory pain.
How similar studies have performed: While research on PEA has shown promise in Europe for inflammatory pain conditions, similar studies have not been conducted in the United States, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chronic Inflammatory Pain of greater than 3 months duration and greater than or equal to 5/10 intensity that has not responded to other conservative therapies such as rest, ice, compression or other oral medications. Exclusion Criteria: * Severe allergy to any specific food component such as nut, egg or soy
Where this trial is running
San Diego, California
- Naval Medical Center San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Brian McLean Pain Physician, MD
- Email: brian.c.mclean.mil@health.mil
- Phone: 619-532-8495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.