Trials / Completed
CompletedNCT04034394
Electromoxibustion and Knee Health Education for Knee Osteoarthritis in Older Adults
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- The Hong Kong Polytechnic University · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Electromoxibustion | Electromoxibustion is a electric device that mimic the burning or moxa. Subjects in this group will receive electromoxibustion using a knee-brace-like device which produces thermal stimulation with a moxa pad inside. The treatment will be delivered 3 times per week for 4 weeks. |
| OTHER | Knee health education | Subjects in this group will attend 2 lessons (120 minutes each) of health education related to knee OA symptom management in a small group of 5-7 subject. The course content is developed from the course materials from the websites of Elderly Health Service, Department of Health, Hong Kong SAR. |
Timeline
- Start date
- 2019-09-20
- Primary completion
- 2019-12-30
- Completion
- 2020-03-30
- First posted
- 2019-07-26
- Last updated
- 2024-04-15
Locations
1 site across 1 country: Hong Kong
Source: ClinicalTrials.gov record NCT04034394. Inclusion in this directory is not an endorsement.