Palmitoylethanolamide for Chronic Inflammatory Pain Conditions

Chronic Pain Clinical Trial

Official title:

Randomized Placebo-Controlled Trial of Palmitoylethanolamide for Chronic Inflammatory Pain Conditions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06273462
• Other study ID #: NMCSD.2024.0006
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: February 2024
• Source: Navy Medical Center San Diego
• Contact: Brian McLean Pain Physician, MD
• Phone: 619-532-8495
• Email: brian.c.mclean.mil[@]health.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate if a supplement called palmitoylethanolamide (PEA) is effective in reducing the pain in patients with chronic inflammatory pain conditions. The main question the trial aims to answer is if PEA works better at treating a patients pain and improving their function better than a placebo.

Participants will be divided into two equal groups and asked to take either PEA or a placebo for 8 weeks.

Description:

Chronic inflammatory pain conditions, such as rheumatoid arthritis, fibromyalgia, and neuropathic pain syndromes, present a significant burden on individuals and healthcare systems worldwide. Despite advancements in pain management, many patients continue to experience inadequate relief, and the long-term use of conventional analgesics can be associated with adverse effects.

Palmitoylethanolamide (PEA) is a naturally occurring fatty acid amide that has garnered attention in recent years for its potential therapeutic properties in managing chronic inflammatory pain. PEA is an endogenous lipid mediator and a member of the N-acylethanolamine family. It exerts its effects primarily by interacting with peroxisome proliferator-activated receptor alpha (PPAR-α) and through other molecular pathways involved in neuroinflammation and immune responses.

In Europe where nutraceuticals are more commonly used in conventional practice, research on PEA has shown significant promise in studies on inflammatory pain conditions such as chronic pelvic pain, irritable bowel syndrome, temporomandibular joint arthritis and knee osteoarthritis. Similar studies have not been completed in the United States.

1. Anti-Inflammatory Effects:

• PEA has demonstrated anti-inflammatory properties by modulating immune responses, inhibiting mast cell activation, and reducing the release of pro-inflammatory cytokines. These effects suggest its potential in attenuating the underlying inflammation in chronic pain conditions.

2. Analgesic Effects:

• Several animal studies have reported that PEA can alleviate pain in models of neuropathic pain, inflammatory pain, and even in more complex pain conditions like fibromyalgia. These findings suggest that PEA may have a role as an analgesic agent.

3. Safety and Tolerability:

• PEA is generally well-tolerated with a favorable safety profile. Clinical trials and real-world studies have reported minimal side effects, making it a potentially attractive option for long-term use in chronic pain management.

4. Clinical Trials:

• Some clinical trials have explored the use of PEA in specific chronic pain conditions. While results have been promising, larger, well-controlled trials are needed to establish its efficacy conclusively.

5. Mechanisms of Action:

• Beyond PPAR-α activation, PEA may also influence other cellular pathways involved in pain modulation, such as TRPV1 channels and GPR55 receptors, although the exact mechanisms are still being elucidated.

Summary of previous trials:

A recent systematic review and meta-analysis of no US studies suggests that PEA is an effective and well-tolerated treatment for chronic pain. The literature search identified 253 unique articles with 11 included in the meta-analysis. The 11 articles had a combined sample size of 774 patients with diverse chronic pain conditions who took a dose of 400-1200 mg of a PEA supplement or a placebo over periods ranging from 2 to 12 weeks. The studies showed significantly better pain reduction compared to placebo with no adverse effects.

Given the growing interest in PEA as a potential therapeutic agent for chronic inflammatory pain, and the lack of any known side effects of this supplement, this randomized placebo-controlled trial aims to contribute valuable data to the existing body of research. By rigorously evaluating the efficacy and safety of PEA in a controlled clinical setting, the investigators seek to provide evidence-based insights into its role in managing chronic inflammatory pain conditions and further inform clinical practice.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: May 30, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Palmitoylethanolamide 600mg twice a day
600mg palmitoylethanolamide twice a day

Other:
• placebo
visually identical placebo capsule

Locations

Country	Name	City	State
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Navy Medical Center San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Level	Pain level will be assessed using the Defense and Veterans Pain Rating Scale (DVPRS) Where the minimum value is 0 indicating no pain and the maximum value is 10 indicating worst possible pain	4 and 8 weeks
Secondary	Pain interference and function	Daily Pain Impact (interference with activity, sleep, mood, stress) (0-10 scale with 0 being the best and 10 being the worst outcome)	4 and 8 weeks
Secondary	Pain Catastrophizing Scale (PCS)	Pain Catastrophizing Scale (PCS) (Helplessness; Magnification; Rumination) (0-52 scale with 0 being the best and 52 being the worst outcome)	4 and 8 weeks
Secondary	Patient Reported Outcome Measurement Information System (PROMIS) (Pain interference, Social satisfaction; Physical function)	PROMIS (Pain interference, Social satisfaction; Physical function) (0-10 each with 0 being the worst and 10 being the best outcome)	4 and 8 Weeks