An Implementation Science Approach to Evaluating Self-Administered Acupressure for Knee Osteoarthritis in Older-Aged Adults in the Community
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- Numerical rating scale (NRS) for pain severity
研究概览
简要总结
This study aims to evaluate the implementation and effectiveness of a self-administered acupressure (SAA) program for knee osteoarthritis (OA) among older adults in Hong Kong community centers. Using a pragmatic cluster randomized controlled trial (RCT) and mixed-methods approach, the research will assess the reach, adoption, implementation, maintenance, and effectiveness of the SAA program in real-world settings, with the goal of informing scalable interventions for knee OA management.
详细描述
Knee OA is a prevalent and debilitating condition in older adults, often managed with medications that have side effects or nonpharmacological interventions requiring significant behavioral change. Acupressure, a variant of acupuncture, can be self-administered after appropriate training and has shown efficacy in previous RCTs for knee OA. This study will implement the SAA program in district elderly community (DEC) centers across Hong Kong, training frontline workers and older adults to deliver and practice acupressure. The intervention includes two training sessions, ongoing support, and a 24-week follow-up. Effectiveness will be measured by pain reduction, improved knee function, and quality of life, while implementation outcomes will be evaluated using the RE-AIM framework. Qualitative interviews will explore facilitators and barriers to adoption and sustainability.
Objectives:
- To explore the reach, adoption, implementation, and maintenance of the SAA program among community service units.
- To examine the effectiveness of the SAA program in relieving pain and improving knee function in middle-aged and older adults in real-world settings.
- To explore the experiences (facilitators and barriers) of adopting SAA in routine services through qualitative interviews.
Hypothesis
- The SAA program will be effectively implemented in community settings, achieving high reach, adoption, fidelity, and sustainability.
- Participants in the SAA group will experience greater reductions in knee pain and improvements in knee function and quality of life compared to the control group.
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
- 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;
- •able to read Chinese and comprehend Mandarin or Cantonese;
- •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 on those with age >50 years yielded 84% sensitivity, and 89% specificity for OA knee diagnosis (25));
- •having knee pain for at least 3 months (26);
- •knee pain 23 on a Likert pain scale from 1-10;
- •having a smartphone (or a family member living together having a smartphone) that is compatible with WhatsApp (based on our previous studies, almost every eligible subject is used to using WhatsApp for social communication); and
- •willing to provide informed consent.
排除标准
- •medical diagnoses or conditions that preclude individuals from active participation (e.g., bleeding disorders, alcohol, or drug abuse);
- •knee pain related to other conditions (cancer, fracture, rheumatoid arthritis, and rheumatism) as screened according to the red flags for further investigation or referral in the NICE 2014 Guidelines for Osteoarthritis of the knee (27);
- •score < 22 in Hong Kong Montreal Cognitive Assessment (HK-MoCA) indicating cognitive impairment that may prevent the understanding of training instructions (28);
- •body mass index over 30, the obese Il criteria for Asians (29) (obese subjects will find great difficulty in performing acupressure on acupoints because physical pressure reaching the muscle is required); and
- •ever had knee-replacement surgery
- •Further investigation or referral, either at the screening or during the study, will be made whenever necessary.
研究组 & 干预措施
Self-Administered Acupressure (SAA) Intervention for Knee Osteoarthritis Management
A training course will be offered to subjects in this group to train them to perform self-acupressure.
干预措施: Experimental Group: Self-Administered Acupressure (SAA) (Other)
General Health Education
A booklet of general health education will be offered to the subjects in this group by the research personnel. The research staff will briefly explain the content covered by the booklet and instruct the subjects to read the booklet at home.
干预措施: Control Group: General Health Education (Other)
结局指标
主要结局
Numerical rating scale (NRS) for pain severity
时间窗: Baseline, Week 4, Week 12, Week 24
Numerical rating scale (NRS) for pain severity The NRS indicates the average pain intensity in the recent one week in the knee. NRS is a single Il-point numeric scale ranging from 0 (no pain) to 10 (greatest pain imaginable). The NRS is a valid and acceptable measure to detect changes in patients' improvement. NRS is chosen as primary outcome because our previous study suggests that the acupressure treatment protocol is more likely to improve global pain intensity. NRS has been used as the primary outcome in recent large-scale RCTs of acupuncture and procedural interventions for knee OA.
次要结局
- Short Form 6D (SF-6D)(Baseline, Week 4, Week 12, Week 24)
- Fast Gait Speed test(Baseline, Week 4, Week 12, Week 24)
- Compliance Assessment(Baseline, Week 4, Week 12, Week 24)
- Western Ontario and McMaster University Osteoarthritis Index(Baseline, Week 4, Week 12, Week 24)
- Timed Up and Go Test(Baseline, Week 4, Week 12, Week 24)
- Analgesic Usage(Baseline, Week 4, Week 12, Week 24)