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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.
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:
Hypothesis
Design and subjects:
Design: Pragmatic cluster randomized controlled trial (RCT) with mixed-methods (quantitative and qualitative).
Setting: District Elderly Community (DEC) centers in Hong Kong.
Subjects:
Interventions:
SAA Group (Focus Group):
General Health Education Group (Control Group):
Main outcome measures:
The outcome measures will include treatment effectiveness and implementation.
Effectiveness Outcome Primary outcome measure is the numerical rating scale for knee pain. Other measures include Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Short-Form Six-Dimension (SF-6D), Timed Up & Go Test (TUG) and Fast Gait Speed (FGS).
Implementation Outcome RE-AIM framework will be used to evaluate the project, which covers five aspects of reach, effectiveness, adoption, implementation, and maintenance.
Data Analysis
Quantitative:
Qualitative:
Cost-Effectiveness:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Administered Acupressure (SAA) Intervention for Knee Osteoarthritis Management | Experimental | A training course will be offered to subjects in this group to train them to perform self-acupressure. |
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| General Health Education | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Group: Self-Administered Acupressure (SAA) | Other | Participants 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 4, Week 12, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 4, Week 12, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 24 |
| Implementation outcome measures- Adoption |
Inclusion Criteria:
Exclusion Criteria:
Further investigation or referral, either at the screening or during the study, will be made whenever necessary.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wing-Fai YEUNG, PhD | Contact | 27664151 | jerry-wf.yeung@polyu.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| WIng-Fai YEUNG, Phd | School of Nursing. the Hong Kong Polytechnic University, Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Recruiting | Kowloon | Hong Kong |
We did not obtain consent from the participants regarding sharing data.
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| Control Group: General Health Education | Other | The 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. |
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| 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). | Baseline, Week 4, Week 12, Week 24 |
| 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. | Baseline, Week 4, Week 12, Week 24 |
| 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. | Baseline, Week 4, Week 12, Week 24 |
| Analgesic Usage | Medication Use: Participants may continue their usual medications, with analgesic use recorded during follow-up. They will be asked to fill in a daily log to record their frequency (in times) of analgesic used. | Baseline, Week 4, Week 12, Week 24 |
| Compliance Assessment | Compliance Assessment: Attendance at training and daily practice logged in acupressure logbooks. They are required to fill in their number of practice in the logbook daily. | Baseline, Week 4, Week 12, Week 24 |
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.
| Week 24 |
| 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. | Week 24 |
| 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. | Week 24 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010146 | Pain |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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