Research

Independent Clinical Trial with OptiPEA®: an overview

The randomized, double-blind, placebo-controlled crossover trial aimed to evaluate the effects of Palmitoylethanolamide (PEA) on pain intensity, central and peripheral sensitization, and pain modulation in healthy volunteers. The study was conducted at the Medical University of Graz, Austria, and included 14 participants (8 women and 6 men) over two 28-day treatment periods separated by an 8-week washout phase.

Study Design and Methods

Participants were randomly assigned to receive either 400 mg of PEA or a placebo three times daily. The study utilized a validated pain model known as Repetitive Phasic Heat Application to measure pain thresholds and sensitivity. Key assessments included cold pain tolerance (CPT), pressure pain threshold (PPT), conditioned pain modulation (CPM), and the wind-up ratio (WUR). The study also measured heat pain thresholds (HPT) and distance of allodynia to capture the effects on both peripheral and central sensitization.

Key Findings

  • Reduced Pain Sensitivity: PEA significantly reduced repetitive heat pain (41 ± 11 vs. 52 ± 13 on the VAS, p = 0.048) and improved pressure pain tolerance (7.7 ± 1.5 kg vs. 7.1 ± 1.5 kg, p = 0.0013) compared to placebo.
  • Improved Cold Pain Tolerance: Participants taking PEA had a significantly longer cold pain tolerance (65 ± 30 s vs. 54 ± 27 s, p = 0.0023).
  • Reduced Central Sensitization: PEA reduced the wind-up ratio (1.3 ± 0.3 vs. 1.5 ± 0.3, p = 0.043) and decreased the average distance of allodynia (1.6 ± 0.6 cm vs. 2.1 ± 0.8 cm, p = 0.0011).
  • Peripheral Effects: PEA increased heat pain tolerance (HPT) (42.5 ± 1.4°C vs. 41.4 ± 1.9°C, p = 0.014), though it did not significantly change heat detection threshold (HDT) (34.2 ± 2.3°C vs. 34.05 ± 2.4°C, p = 0.97).

Safety and Tolerability

No adverse effects were reported, aligning with previous studies indicating that PEA is generally well-tolerated. The 99.4% compliance rate for PEA and 98.1% for placebo indicates high participant adherence and study reliability.

Conclusion

The study demonstrates that PEA, supplied by Innexus Nutraceuticals as OptiPEA®, has clinically relevant analgesic properties affecting both peripheral and central pain mechanisms as well as pain modulation. This makes PEA a promising therapeutic option for chronic pain management and conditions involving central sensitization.

Source

The Effect of Palmitoylethanolamide on Pain Intensity, Central and Peripheral Sensitization, and Pain Modulation in Healthy Volunteers—A Randomized, Double-Blinded, Placebo-Controlled Crossover Trial – Nutrients 2022