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Palmitoylethanolamide for Knee Fracture

Phase 2
Waitlist Available
Led By Ariana Nelson, MD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will study whether the inclusion of PEA (a non-psychoactive cannabis compound) in conjunction with standard post-surgical medications can reduce pain and inflammation while decreasing the number of opioids needed.

Eligible Conditions
  • Knee Fracture
  • Tibial Fracture
  • Fibula Fracture

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
3 month post-surgical NSAID use Questionnaire
3 month post-surgical Opioid use Questionnaire
Secondary outcome measures
Average Pain Interference
Average Pain Scores
Functional Status
+4 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: PalmitoylethanolamideActive Control1 Intervention
300 mg PEA twice a day for a total of 600 mg PEA daily 2-month supply upon discharge
Group II: PlaceboPlacebo Group1 Intervention
1 placebo tablet twice a day for a total of 2 tablet placebo daily 2-month supply upon discharge

Find a Location

Who is running the clinical trial?

GE Nutrients Inc. (Gencor)UNKNOWN
University of California, IrvineLead Sponsor
542 Previous Clinical Trials
1,922,001 Total Patients Enrolled
Ariana Nelson, MDPrincipal InvestigatorAssociate Clinical Professor
1 Previous Clinical Trials
105 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment recruiting participants currently?

"According to the data available on clinicaltrials.gov, this medical trial remains open and is actively accepting patients. It was initially posted on April 1st 2022 with a most recent update occurring at the end of March 2021."

Answered by AI

What goals has this research endeavor been designed to accomplish?

"This trial's primary goal, to be assessed over a 3 month period of time, is to assess post-surgical opioid use through questionnaires. Secondary outcomes include Post-Surgical Complications, Pain Interference (measured via PROMIS) and Average Pain Intereference (measured via BPI). Raw scores are converted into T-scores with means of 50 and standard deviations of 10."

Answered by AI

How many individuals have been accepted to participate in this research trial?

"Affirmative, clinicaltrials.gov's records reflect that this research project, first published on April 1st 2022 is still recruiting participants. 50 individuals are needed to be enrolled at 2 separate medical facilities."

Answered by AI

Is Palmitoylethanolamide safe to consume, and if so, what is the recommended dosage?

"Our team evaluated the safety of palmitoylethanolamide to be a 2 since it is currently in phase two; thus far, there are studies verifying its security but not yet any evidence demonstrating efficacy."

Answered by AI
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~0 spots leftby Dec 2024