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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electromoxibustion | Experimental | Participants in this group will receive electromoxibustion using a knee-brace-like device which produces thermal stimulation with a moxa pad inside (Fort Mayer, Guangzhou, China). |
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| Knee health education | Active Comparator | Participants in this group will attend 2 sessions (120 minutes each, 1-week apart) of health education related to knee OA symptom management. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electromoxibustion | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain severity numerical rating scale, NRS | The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). It has been shown that a composite scoring system including best, worse, and current level of pain over the last 24 hours was sufficient to pick up changes in pain intensity with maximal reliability. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster University Osteoarthritis Index (WOMAC) | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales.The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wing Fai YEUNG | Hong Kong | 000000 | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33190009 | Derived | Cheung T, Ho YS, Yuen CS, Lam CS, Chun-Lung So B, Chen SC, Leung DYP, Kwai-Ping Suen L, Tin-Yau So L, Chun-Hei Ho A, Yeung WF. Electromoxibustion for knee osteoarthritis in older adults: A pilot randomized controlled trial. Complement Ther Clin Pract. 2020 Nov;41:101254. doi: 10.1016/j.ctcp.2020.101254. Epub 2020 Nov 6. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Assessors will be blinded to the group allocation.
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| Knee health education | Other | 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. |
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| Week 4 |
| Short Form-6D | The SF-6D, which is derived from the 36-item Short Form Health Survey (SF-36), is one of the most widely used generic measures of HRQoL in clinical trials. The score ranges from 0 to 1. | Week 4 |
| Timed Up & Go Test (TUG) | The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. | Week 4 |
| Fast Gait Speed (FGS) | Subjects will be asked to walk 4 metres at their normal pace. Their gait speed in metres per second will be calculated. | Week 4 |
| D012216 |
| Rheumatic Diseases |