Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 29, 2023
Date Accepted: May 14, 2024
Date Submitted to PubMed: May 23, 2024
Combination of Curcuminoid with Acupressure for Inflammation and Pain in Elderly People with Osteoarthritis Genu: Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Curcuminoids and acupressure have beneficial effects in reducing pain and inflammation in patients with Osteoarthritis. However, only a few clinical trials are investigating biomarkers to prove this objectively
Objective:
This study aimed to investigate the efficacy of acupressure and curcuminoids to inflammatory markers and pain in elderly with Osteoarthritis Genu.
Methods:
Randomized controlled trial was conducted among elderly with Osteoarthritis. All participants were randomized to divided into the group with 30 mg curcuminoids from turmeric extract capsules and acupressure (group 1) or the group with placebo and sham acupressure (group 2) for 3 weeks.
Results:
The study was approved by the research ethics board and Clinical Trials.gov had reviewed this protocol under Registration number: NCT06105840. The extracts were manufactured from May 2023 to June 2023. Participant recruitment was conducted in September-October 2023, a total of 72 participants aged over 60 years had participated of whom 75.0% (n=54) were female. Data was analyzed in April of 2024, and dissemination of results by the end of 2024.
Conclusions:
Primary outcomes were assessed at baseline and after intervention and related to inflammatory markers, endorphin hormones, and cycloxygenase-2 hormone in the blood. Additionally, secondary outcomes included pain, ability to activity daily living, and quality of life. The beneficial effects that may be found in this trial can be exceptionally relevant in clinical practice, justifying this scientific question. The benefits of herbs and acupressure can be helpful to additional options in treating inflammation and pain in patients with Osteoarthritis. Clinical Trial: The ethics research committee has approved the study protocol registered with the Forum for Ethical Review Committees in Asia and the Western Pacific (FERCAP) (project number KE-FK-0674-EC-2023). The study was conducted according to Indonesia's 2021 National Health Research and Development Ethical Guidelines and Standards by the Health Research and Development Ethics Committee and the Helsinki Declaration, revised in 2013. Clinical Trials.gov has reviewed this protocol under Registration number: NCT06105840.
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