Ignite Creation Date:
2024-05-06 @ 5:43 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05406726
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2022-06-01
Brief Title:
Mechanisms of Palmitoylethanolamide PEA to Alter Pain Sensitivity in Knee Osteoarthritis
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Mechanisms of Palmitoylethanolamide PEA to Alter Pain Sensitivity in Knee Osteoarthritis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Knee osteoarthritis KOA affects nearly 30 of adults aged 60 years or older and causes significant pain and disability1 Neurophysiological testing quantitative sensory testing QST demonstrates that KOA pain has both peripheral and central mechanisms which vary by individual2 Adults with central KOA pain tend to be resistant to traditional pain treatment and have substantial pain even after knee replacement surgery3 There is a growing body of evidence to support the scientific premise that endocannabinoids and related molecules in particular PEA can improve KOA pain through anti-inflammatory and analgesic pathways45 PEA has little or no known side effects and is safe for human consumption6 However there is little known regarding the specific mechanisms by which PEA works to relieve KOA pain or for whom it might work best We will begin to address this mechanistic question in this pilot study which will provide data regarding therapeutic strategies within the endocannabinoid system to reduce KOA pain The National Academies of Science Engineering and Medicine report on the Health Effects of Cannabis and Cannabinoids 2017 supports cannabinoids as treatment for chronic pain but highlighted the need for quality clinical trials To fill this gap the purpose of this study is to explore the impact of oral PEA a non-psychoactive endocannabinoid enhancer with little to no side effects to alter pain related biomarkers Our central hypothesis is that PEA will alter pain related protein signatures inflammatory markers and neurophysiological changes in adults with KOA pain
The investigators propose a crossover clinical trial of 20 adults with self-reported medical diagnosis of KOA and knee pain min 410 on numeric rating scale This study will explore mechanisms of taking 1200mg of oral PEA daily for seven days loading dose then 600 mg daily for an additional 5 weeks six weeks total Ten participants will take PEA for 6 weeks while the other ten will receive placebo Then the groups will switch with the first group receiving placebo and the second group receiving PEA PEA takes 4 to 6 weeks to reduce KOA pain 45 Participants will have blood drawn and quantitative sensory testing at baseline 6- and 12-weeks follow-up Participants will be asked to bring in their PEAplacebo bottles for pill counts to track adherence and will be asked about side effects at each study visit
The investigators will test the central hypothesis and attain the objectives via the following specific aims
Specific Aim 1 To examine the impact of oral PEA placebo on the protein signature of adults with KOA pain We will use high-resolution liquid chromatography-tandem mass spectrometry to examine the entire proteome of the platelet rich plasma isolated from whole blood from each participanttime point to explore whether the PEA can alter the signaling pathways ascribed to KOA pain We hypothesize that PEA will reduce the pro-inflammatory signaling pathways in the systemic proteome among participants in the PEA groups as compared to placebo
Specific Aim 2 To elucidate the effects of oral PEA vs placebo on systemic inflammatory markers related to KOA pain We will measure key inflammatory markers in KOA including interleukin IL-6 IL-1β IL-8 IL-10 IL-15 c-reactive protein CRP and tumor necrosis factor-α at each study visit We hypothesize that PEA will reduce the expression of inflammatory markers seen after walking in KOA participants as compared to placebo
Specific Aim 3 To determine the alterations in neurophysiological changes as measured by Quantitative Sensory Testing QST among participants taking PEA vs placebo For QST we will measure the pressure pain detection and threshold heat and cold detection and threshold and mechanical temporal summation at the affected knee and contralateral forearm at each study visit We hypothesize that PEA will alter central and peripheral pain pathways among adults with KOA We will also compare the biologic pain pathways to the proteome and inflammatory markers
The investigators propose a crossover clinical trial of 20 adults with self-reported medical diagnosis of KOA and knee pain min 410 on numeric rating scale This study will explore mechanisms of taking 1200mg of oral PEA daily for seven days loading dose then 600 mg daily for an additional 5 weeks six weeks total Ten participants will take PEA for 6 weeks while the other ten will receive placebo Then the groups will switch with the first group receiving placebo and the second group receiving PEA PEA takes 4 to 6 weeks to reduce KOA pain 45 Participants will have blood drawn and quantitative sensory testing at baseline 6- and 12-weeks follow-up Participants will be asked to bring in their PEAplacebo bottles for pill counts to track adherence and will be asked about side effects at each study visit
The investigators will test the central hypothesis and attain the objectives via the following specific aims
Specific Aim 1 To examine the impact of oral PEA placebo on the protein signature of adults with KOA pain We will use high-resolution liquid chromatography-tandem mass spectrometry to examine the entire proteome of the platelet rich plasma isolated from whole blood from each participanttime point to explore whether the PEA can alter the signaling pathways ascribed to KOA pain We hypothesize that PEA will reduce the pro-inflammatory signaling pathways in the systemic proteome among participants in the PEA groups as compared to placebo
Specific Aim 2 To elucidate the effects of oral PEA vs placebo on systemic inflammatory markers related to KOA pain We will measure key inflammatory markers in KOA including interleukin IL-6 IL-1β IL-8 IL-10 IL-15 c-reactive protein CRP and tumor necrosis factor-α at each study visit We hypothesize that PEA will reduce the expression of inflammatory markers seen after walking in KOA participants as compared to placebo
Specific Aim 3 To determine the alterations in neurophysiological changes as measured by Quantitative Sensory Testing QST among participants taking PEA vs placebo For QST we will measure the pressure pain detection and threshold heat and cold detection and threshold and mechanical temporal summation at the affected knee and contralateral forearm at each study visit We hypothesize that PEA will alter central and peripheral pain pathways among adults with KOA We will also compare the biologic pain pathways to the proteome and inflammatory markers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None