Mechanisms of Palmitoylethanolamide (PEA) to Alter Pain Sensitivity in Knee Osteoarthritis

NCT05406726 | Completed DMC

• 1 other identifier: HP-00101407
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this 1-year proof of feasibility and acceptability pilot study are twofold. First to determine if participants with knee osteoarthritis (KOA) will comply with taking palmitoylethanolamide (PEA) dietary supplement for 6 weeks and adhere to taking it as directed. Second is to gain preliminary data to elucidate mechanisms (protein signatures, inflammatory markers and neurobiological signaling pathways) by which PEA, a lipid-based endocannabinoid, works to alter pain sensitivity in adults with KOA. In the simplest terms possible, we need to provide evidence that PEA changes the protein signature in order to provide evidence to establish mechanism.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• protein changes

  we will do whole proteome sequencing from blood products to look at changes after taking PEA for 6 weeks versus placebo

  6 weeks

Secondary Outcomes (2)

• inflammatory markers

  6 weeks

• pain sensitivity

  6 weeks

Study Arms (2)

palmitoylethanolamide (PEA)

EXPERIMENTAL

Palmitoylethanolamide (PEA) is a lipid based endocannabinoid dietary supplement currently marketed.

Dietary Supplement: palmitoylethanolamide

Placebo

PLACEBO COMPARATOR

A similar size and shaped capsule containing maltodextrin will be used as a placebo comparator.

Dietary Supplement: Placebo

Interventions

palmitoylethanolamide DIETARY_SUPPLEMENT

palmitoylethanolamide is an lipid based endocannabinoid naturally made by the body and is present in several common foods such as eggs

Also known as: PEA

palmitoylethanolamide (PEA)

Placebo DIETARY_SUPPLEMENT

a capsule filled only with maltodextrin will be used as a placebo

Also known as: Maltodextrin

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 40 to 80
• English speaking
• Self reported diagnosis of osteoarthritis in one or both knees
• Self-reported average knee pain over the past month at least 4 out of 10 on a 0-10 numeric rating scale
• Agreement to abstain from all osteoarthritis pain medication (such as non-steroidal anti-inflammatory drugs or narcotics) and use only acetaminophen as a rescue medication when needed
• Can pass an evaluation to sign consent

You may not qualify if:

• Inflammatory arthritis (eg. Rheumatoid arthritis)
• Knee injury in past 6 months
• Knee surgery in past 12 months or total knee replacement
• Pregnant or breastfeeding
• enrolled in other knee OA rehabilitation programs or clinical trials
• Any of the following conditions: chronic kidney disease stage 3-5, unstable angina, congestive heart failure, cancer or cancer treatment (except skin)
• Oral or intra-articular glucocorticoid use in the prior 3 months; intra-articular hyaluronate use in the prior 6 months
• Opioid use in the past month
• Allergy to oat, coconut, citrus, olive, or sunflower oils, or maltodextrin

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

palmidrol; maltodextrin

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jennifer Klinedinst, PhD, MPH, RN

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

• Susan Dorsey, PhD, RN

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

• Marc Hochberg, MD, MPH

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking will occur as to the order of receiving either PEA or placebo for the first six weeks, then the reverse for the following six weeks.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a crossover clinical trial where 10 participants will receive palmitoylethanolamide (PEA) dietary supplement for 6 weeks and 10 participants will receive placebo for six weeks. Then the following six weeks they will reverse.

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 6, 2022
• Study Start: March 22, 2023
• Primary Completion: January 2, 2024
• Study Completion: January 2, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)