Palmitoylethanolamide for Chronic Inflammatory Pain Conditions

NCT ID: NCT06273462

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-05
• Study Completion Date: 2025-10-30

Brief 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.

Detailed 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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Palmitoylethanolamide

Participants randomized to the experimental arm will receive the supplement Palmitoylethanolamide (PEA) at a dose of 600mg twice a day

Group Type: EXPERIMENTAL

Palmitoylethanolamide 600mg twice a day

Intervention Type: DRUG

600mg palmitoylethanolamide twice a day

Placebo

Participants randomized to the placebo arm will receive a visually identical placebo capsule

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

visually identical placebo capsule

Interventions

Palmitoylethanolamide 600mg twice a day

600mg palmitoylethanolamide twice a day

Intervention Type: DRUG

placebo

visually identical placebo capsule

Intervention Type: OTHER

Other Intervention Names

PEA

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Navy Medical Center San Diego

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Naval Medical Center San Diego

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brian McLean Pain Physician, MD

Role: CONTACT

brian.c.mclean.mil@health.mil

619-532-8495

IRB Administrator

Role: CONTACT

kristina.m.umali.civ@health.mil

619-532-9083

Facility Contacts

Naval Medical Center Institutional Review Board

Role: primary

kristina.m.umali.civ@health.mil

619-532-9927

Other Identifiers

NMCSD.2024.0006

Identifier Type: -

Identifier Source: org_study_id