Self-administered Acupressure for Knee Osteoarthritis in Middle- and Older Adults: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Pain severity numerical rating scale
研究概览
简要总结
Objectives: To test the feasibility of the study design and clinical effects of self-administered acupressure on relieving knee osteoarthritis (OA) pain.
Hypothesis: self-administered acupressure would have a superior beneficial effect compared to health education control group in terms of pain relief in patients with knee osteoarthritis across the 6-week study period.
Design and subjects: A pilot randomized controlled trial. 36 subjects with knee OA will be recruited; 18 per group. All eligible subjects will be randomized to either self-administered acupressure or health education control group in 1:1 ratio.
Interventions: Subjects in the self-acupressure group will attend two 1.5 hours training sessions to learn self-acupressure and will practice self-acupressure every morning and night for 6 weeks; subjects in the education control group will receive two 1.5 hours training sessions to learn the health information related to knee OA.
Main outcome measures: The primary outcome measure is the numerical rating scale for knee pain. Other measures include Western Ontario and McMaster University Osteoarthritis Index, knees' range of motion (ROM), and SF-6D. Acceptability of the self-acupressure training course will also be evaluated.
Data Analysis: Differences in the questionnaire scores and ROM will be examined using a mixed-effects model. Both completer and intention-to-treat analyses will be conducted. Effect sizes will be computed by dividing the difference in means by the pooled standard deviation.
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)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ethnic Chinese;
- •aged 50 -70 years
- •fulfills any 3 of the following criteria proposed by Altman et al., (1986): ( I. morning stiffness</= 30 min; ii. crepitus on active joint motion; iii. bone tenderness; iv. bone enlargement; or v. no palpable joint warmth);
- •having knee pain for at least 3 months;
- •ability to provide informed consent;
- •ability to comprehend Chinese; and
- •Knee pain ≥3/10 and </= 7 on a Likert pain scale from 1-10
排除标准
- •medical diagnoses or conditions that preclude individuals from active participation (bleeding disorders, alcohol or drug abuse);
- •presence of skin lesions or infections at the treatment sites;
- •currently participating in other interventional research studies for knee OA;
- •cognitive impairment preventing informed consent or understanding of instructions
- •body mass index over 25, the obese criteria for Asians (Anuurad et al., 2003);
- •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 NICE 2014 Guidelines for Osteoarthritis of the knee;
- •had previous foot injury or trauma;
- •using of steroid for knee pain;
- •pregnancy or contemplating pregnancy;
- •ever received acupressure for knee OA over the past 6 months.
结局指标
主要结局
Pain severity numerical rating scale
时间窗: Week 6
A single 11-point numeric scale ranges from 0 to 10 in 1 cm intervals (zero: no pain, 10: greatest pain imaginable).
次要结局
- Western Ontario and McMaster University Osteoarthritis Index (WOMAC)(Baseline, Week 2, Week 4, Week 6)
- Range of motion (ROM)(Baseline, Week 6)
- Short Form 6D (SF-6D)(Baseline, Week 6)
研究者
YEUNG Wing Fai
Assistant Professor
The Hong Kong Polytechnic University