Electromoxibustion and Knee Health Education for Knee Osteoarthritis in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Pain severity numerical rating scale, NRS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors will be blinded to the group allocation.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ethnic Chinese;
- •aged 60 years or above;
- •ability to comprehend Chinese;
- •fulfilling any 3 of the following criteria: i. morning stiffness </= 30 min; ii. crepitus on active joint motion; iii. bone tenderness; iv. bone enlargement; or v. no palpable joint warmth (This classification yielded 84% sensitivity and 89% specificity for OA knee diagnosis (Altman et al., 1986);
- •having knee pain for at least 3 months;
- •Knee pain ≥4 on a Likert pain scale from 1-10; and
- •willing to provide informed consent.
排除标准
- •medical diagnoses or conditions that preclude individuals from active participation (e.g. dementia, post-stroke syndrome, alcohol or drug abuse);
- •knee pain related to other conditions (cancer, fracture, rheumatoid arthritis, rheumatism) as screened according to the red flags for further investigation or referral in the National Clinical Guideline Centre 2014 Guidelines for Osteoarthritis of the knee (National Clinical Guideline Centre, 2014);
- •presence of skin lesions or infections at the treatment sites;
- •ever had knee replacement surgery or knee joint implant; and
- •ever received moxibustion, electromoxibustion or steroid injection for knee pain over the past 6 months; Further investigation or referral, either at the screening or during the study, will be made when necessary.
结局指标
主要结局
Pain severity numerical rating scale, NRS
时间窗: Week 4
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.
次要结局
- Short Form-6D(Week 4)
- Western Ontario and McMaster University Osteoarthritis Index (WOMAC)(Week 4)
- Timed Up & Go Test (TUG)(Week 4)
- Fast Gait Speed (FGS)(Week 4)