About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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));
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Experimental Group: Self-Administered Acupressure (SAA)
Other interventionParticipants in this group will receive two acupressure training sessions (2 h each, 1 -week apart). The SAA treatment protocol was developed based on TCM meridian theory described in previous studies and modified by the PA and CO-A who is an experienced acupuncturist. The acupoints are indicated for knee pain and are commonly used tested for feasibility in RCT study. Participants will be asked to perform the acupressure at home in the morning (within 1 h after waking up) and at night (within 1 h after dinner) every day for 24 weeks. Participants will receive a follow-up phone call from the instructor during the first week to remind them to practice and answer their queries. During the intervention and follow-up period, the participants can communicate with the elderly staff/ our research ambassador to ask questions regarding acupressure.
Control Group: General Health Education
Other interventionThe participants of DEC centers in this group will be provided with the general health education booklets despite the same follow-up procedure. The booklets contains general health education information e.g. physical health, sleep health, for the participants' self-reading. The content is based on our previous studies for lifestyle intervention and health information from the government website. They will be told to read the booklet and follow the suggestions in the booklet. They will have the same program after outcome evaluation at 24 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Numerical rating scale (NRS) for pain severity
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.
Secondary outcomes
Western Ontario and McMaster University Osteoarthritis Index
Western Ontario and McMaster University Osteoarthritis Index (WOMAC): Assesses pain, physical function, and stiffness. A total raw score ranges from 0-96. Scores are often converted to a 0-100 scale (0=best, 100=worst) for standardized reporting, with higher numbers indicating greater disability.
Short Form 6D (SF-6D)
Short Form 6D (SF-6D): Measures quality of life. It is a standard tool used to measure health-related quality of life (HRQoL) by assessing six key areas (physical functioning, role limitations, social functioning, pain, mental health, vitality) from the SF-36. The score ranges from 0 (worst quality of life) to 1 (perfect quality of life).
Timed Up and Go Test
Functional Test: the Timed Up and Go Test to evaluate knee function. It is a assessment of functional mobility and fall risk, especially for older adults, involving timing how long it takes to stand from a chair, walk 3 meters, turn, walk back, and sit down. The time will be recorded (in seconds) for completing the task.
Fast Gait Speed test
Functional Test: Fast Gait Speed test to evaluate knee function. It measures how fast the subject walks by timing them over a 10 m distance where you accelerate for 2m, walk quickly (safely) for 6m , and decelerate for 2m. The time, in seconds, will be recorded for completing the task.
Other outcomes
Implementation outcome measures -Reach from District Elderly Centers (DEC)
Reach: Reached will be evaluated through data documentation, including the screening rate of participants for eligibility
Implementation outcome measures- Adoption
Adoption: Adoption will track the number of DEC units that implement the intervention and record reasons for any discontinuation. They will be asked whether their units held any more session of SAA training after our study.
Implementation outcome measures - satisfaction
Implementation: Implementation will assess the stakeholders' perception if the intervention is agreeable and the degree to which an intervention is implemented as planned. Satisfaction of participants and providers will be measured using a 15-item questionnaire adapted from a previous community based health-social partnership study, with confirmed validity and reliability. The frontline workers need to record intervention fidelity by using a fidelity checklist for evaluating implementation. The checklist serves to measure the extent to which the core intervention components were delivered as planned. Documentation will be updated by the units with assistance from the research assistant throughout the study period and audited by the research team once every three months.
Implementation outcome measures - Maintenance
The number of SAA program (and participants) launched by the DEC beyond the follow-up period (24-week) will be recorded.
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