The Effect of Palmitylethanolamide on Central and Peripheral Sensitization After Heat-induced Hyperalgesia

NCT04662827 | Completed

• 1 other identifier: 1403/2019
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This planned study is based on a randomized, placebo-controlled cross-over design. Palmityhlethanolamide (PEA) is an endogenous fatty acid amide from the group of N-Acetylethanolamides, which analgesic, anti-inflammatory and neuroprotective effects can be attributed to this. In clinical studies, PEA has mainly been used as an adjuvant in pain therapy. The previous data show clinical efficacy without conclusions that can be drawn about the underlying mechanisms - these have not yet been investigated in a human experiment. The planned study, which demonstrates the mode of action of PEA using an established pain model on healthy volunteers, will help to assign the efficacy to peripheral or central nervous systems. These mechanisms allow to establish mechanism-oriented therapy approaches. These findings are essential for a better understanding of the clinical efficacy and to evaluate the correct fields of application.

Conditions

Pain, Chronic; Pain, Acute; Central Sensitisation; Neuroinflammatory Response

Outcome Measures

Primary Outcomes (6)

• Change in spontaneous pain intensity

  is measured on a visual analogue scale (0 means no pain and 10 means the worst imaginable pain)

  -->Day 0 -->Day 28 before repeated heat application -->Day 28 1 hour after repeated heat application --> Day 56 -->Day 112 before repeated heat application -->Day 112 1 hour after repeated heat application

• Change in Allodynia

  measured in radial distance in mm

  -->Day 0 -->Day 28 before repeated heat application -->Day 28 1 hour after repeated heat application --> Day 56 -->Day 112 before repeated heat application -->Day 112 1 hour after repeated heat application

• Change in Hyperalgesia

  measured with pinpricks, that are preset different peak stimulus. A numerical scale (0-100) is used to measure how painful the stimulus is.

  -->Day 0 -->Day 28 before repeated heat application -->Day 28 1 hour after repeated heat application --> Day 56 -->Day 112 before repeated heat application -->Day 112 1 hour after repeated heat application

• Change in heat detection threshold

  measured in degrees

  -->Day 0 -->Day 28 before repeated heat application -->Day 28 1 hour after repeated heat application --> Day 56 -->Day 112 before repeated heat application -->Day 112 1 hour after repeated heat application

• Change in heat pain threshold

  measured in degrees

  -->Day 0 -->Day 28 before repeated heat application -->Day 28 1 hour after repeated heat application --> Day 56 -->Day 112 before repeated heat application -->Day 112 1 hour after repeated heat application

• Change in conditioned pain modulation

  measures the descending analgesic System with the help of a pressure agometer in kg

  -->Day 0 -->Day 28 before repeated heat application -->Day 28 1 hour after repeated heat application --> Day 56 -->Day 112 before repeated heat application -->Day 112 1 hour after repeated heat application

Study Arms (2)

Palmithylethanolamid

EXPERIMENTAL

Probands receive PEA 3xday for 28 days, 8 weeks wash out will follow, then they receive placebo for 28 days

Dietary Supplement: Palmithylethanolamid; Other: placebo

placebo

PLACEBO COMPARATOR

Probands receive placebo 3xday for 28 days, 8 weeks washout will follow, then they receive PEA for 28 days

Dietary Supplement: Palmithylethanolamid; Other: placebo

Interventions

Palmithylethanolamid DIETARY_SUPPLEMENT

PEA 3x/d

Palmithylethanolamid; placebo

placebo OTHER

placebo 3x/d

Palmithylethanolamid; placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Chronic pain
• Analgesic intake
• Neurological illness
• Dermatological illness
• Cardiovascular illness
• PEA Allergy

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical university of Graz

Graz, 8010, Austria

Location

Related Publications (1)

• Paladini A, Fusco M, Cenacchi T, Schievano C, Piroli A, Varrassi G. Palmitoylethanolamide, a Special Food for Medical Purposes, in the Treatment of Chronic Pain: A Pooled Data Meta-analysis. Pain Physician. 2016 Feb;19(2):11-24.

  PMID: 26815246 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• helmar Boremann-cimenti

  Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria. helmar.bornemann@medunigraz.at

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The masking is done by the pharmacological department also produces the placebos
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: doubleblind, placebo-controlled,prospective crossover study

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 10, 2020
• Study Start: February 9, 2020
• Primary Completion: September 16, 2020
• Study Completion: September 16, 2020
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)