Probiotics and Palmitoylethanolamide (PEA) for Osteoarthritic Pain and Wellbeing

Not Applicable

Completed

• Conditions: Osteoarthritis; Wellbeing; Alternative and Complementary Medicine - Other alternative and complementary medicine; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12621000039886
• Lead Sponsor: Southern Cross University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-18
• Study Completion: 2021-11-27
• Last Update Posted: 31 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

•Individuals aged between 18 and 85 years
•Medical diagnosis or clinical evidence of osteoarthritis in any site
•Individuals who describe chronic/symptomatic osteoarthritic pain in the affected joint
•In good general health
•Female participants of childbearing age who agree to continue using birth control measures for the duration of the study

Exclusion Criteria

•A history of trauma associated with the affected joint
•Rheumatoid arthritis or other inflammatory joint conditions
•Recent history gout
•Individuals with diabetes
•Individuals with a compromised immune system
•Individuals taking antidepressant medications for less than 6 months or who have experienced psychological side effects as a result of antidepressant medication in the last 6 months.
•Individuals taking Warfarin or other anti-coagulant medication
•Use of corticosteroids (intra-articular or systematic) within 4 weeks prior to baseline and throughout the study
•Female participants who are lactating, pregnant or planning to become pregnant
•Participants who have participated in another clinical trial in the last 30 days
•Participants unwilling to comply with the study protocol
•Any other condition, which in the opinion of the investigators could compromise the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in mean pain scores between placebo and active phases as measured daily on a 10cm Numerical Rating Scale (NRS)[This will be measured daily from the commencement of the trial (baseline measures in week 1) until the trial conclusion (primary endpoint in week 11).]