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This is a randomized controlled trial comparing the short-term effect of electromoxibustion and knee health education for relieving knee pain in older adults with knee osteoarthritis.
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Objective: This pilot randomized controlled trial (RCT) will preliminary examine the effects of an electromoxibustion device and knee health education on reliving knee osteoarthritis (OA) pain.
Method Design: This pilot RCT will embed a two-arm randomized control trial. The project will recruit 48 participants with knee OA. Eligible participants will be randomized into 2 groups - (1) Electromoxibustion, or (2) knee health education at 1:1 ratio.
Interventions: Participants in the electromoxibustion group will receive electromoxibustion using a knee-brace-like device which produces thermal stimulation with a moxa pad inside (Fort Mayer, Guangzhou, China); participants in the Knee health education group will attend 2 sessions (120 minutes each, 1-week apart) of health education related to knee OA symptom management.
Outcome measures: (1) Pain severity numerical rating scale (NRS) (Primary outcome); (2) Western Ontario and McMaster University Osteoarthritis Index (WOMAC) for pain, physical function, and stiffness related to knee osteoarthritis; (3) Short Form-6 Dimensions for quality of life; (4) Timed Up & Go Test (TUG); (5) Fast Gait Speed (FGS) for knee functioning.
Statistical Analysis of quantitative data: Descriptive statistics will be used to describe the socio-demographic characteristics of the participants. A mixed-effects model with consideration of repeated measures and dropout by including all available data points (intention-to-treat analysis) to compare the electromoxibustion with the knee health education control group. SPSS version 23.0 will be used in this study.
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48 participants in 2 patient groups
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WF Yeung, PhD
Data sourced from clinicaltrials.gov
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