An interventional study of The C-MPPM intervention and Online education in Knee Osteoarthritis, sponsored by The Hong Kong Polytechnic University. Enrolling by invitation at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Supportive care
Knee osteoarthritis (OA) is a prevalent degenerative joint disease that causes chronic pain, stiffness, impaired physical function, and associated psychosocial issues such as depression, insomnia, and loneliness. This feasibility study develops and evaluates a chatbot-based mindful physical-psychosocial pain management (C-MPPM) intervention grounded in the biopsychosocial model. The 8-week rule-based chatbot (Cantonese, voice-enabled) delivers integrated mindfulness training, tailored physical exercises, and social support. A feasibility randomised controlled trial will explore the feasibility, acceptability, and preliminary effects of the C-MPPM intervention among people with knee OA. Findings will inform a future full-scale randomised controlled trial and provide scalable, accessible pain management solutions for community-dwelling individuals with knee OA.
This study consists of two phases: (1) development of the C-MPPM intervention and (2) a feasibility randomised controlled trial. Phase 1 involves creating coherent conversational flows for the rule-based chatbot incorporating mindfulness training, physical exercise, and social support elements. Phase 2 recruits Hong Kong community-dwelling adults with knee OA to be randomly assigned to receive the 8-week C-MPPM intervention or online education. The C-MPPM intervention includes eight weekly sessions: Session 1 - Orientation and engagement; Session 2 - Awareness and acceptance; Session 3 - Non-judgement; Session 4 - Response without reacting; Session 5 - Self-compassion and mindful communication; Session 6 - Managing difficulties and social support; Session 7 - Seek out pleasant things and social connection; and Session 8 - Review the programme and future plan. Following the completion of each session (around one hour), participants will also be reminded to practice mindful exercises as homework in the following week (at least five days per week with 30 minutes each day). The control group will receive online education over eight weeks, which includes information on World Health Organization-recommended physical activity, encouragement, and practical tips for exercises based on OA management guidelines. The online education will not include mindfulness or social support strategies. Participants in this group will be instructed to engage in online education for one hour per week. Pre- and post-intervention quantitative assessments will be conducted. Qualitative interviews will be conducted with purposefully selected participants in the intervention group to gather feedback on their general experience, strengths, and limitations of the intervention.
Exclusion Criteria:
The C-MPPM intervention includes eight weekly sessions: Session 1 - Orientation and engagement; Session 2 - Awareness and acceptance; Session 3 - Non-judgement; Session 4 - Response without reacting; Session 5 - Self-compassion and mindful communication; Session 6 - Managing difficulties and social support; Session 7 - Seek out pleasant things and social connection; and Session 8 - Review the programme and future plan. Following the completion of each session (around one hour), participants will also be reminded to practice mindful exercises as homework in the following week (at least five days per week with 30 minutes each day).
Behavioral: The C-MPPM intervention
The control group will receive online educational messages via WhatsApp over eight weeks, which includes information on World Health Organization-recommended physical activity, encouragement, and practical tips for exercises based on OA management guidelines. The online education will not include mindfulness or social support strategies. Participants in this group will be instructed to engage in online education for one hour per week.
Behavioral: Online education
The C-MPPM intervention includes eight weekly sessions: Session 1 - Orientation and engagement; Session 2 - Awareness and acceptance; Session 3 - Non-judgement; Session 4 - Response without reacting; Session 5 - Self-compassion and mindful communication; Session 6 - Managing difficulties and social support; Session 7 - Seek out pleasant things and social connection; and Session 8 - Review the programme and future plan. Following the completion of each session (around one hour), participants will also be reminded to practice mindful exercises as homework in the following week (at least five days per week with 30 minutes each day).
The control group will receive online educational messages via WhatsApp over eight weeks, which includes information on World Health Organization-recommended physical activity, encouragement, and practical tips for exercises based on OA management guidelines. The online education will not include mindfulness or social support strategies. Participants in this group will be instructed to engage in online education for one hour per week.
Recruitment rate: percentage of eligible individuals approached who provide informed consent, assessed using the recruitment screening log
Time frame: From the start of recruitment to the completion of baseline enrollment
Randomisation rate: percentage of consenting participants who are randomised, assessed using the study randomization log
Time frame: Baseline
Retention rate: percentage of consenting participants who complete the study, assessed using the study retention log
Time frame: Through study completion, an average of two months
Attendance rate: percentage of required practice sessions completed, assessed using the study practice log
Time frame: At the end of the intervention, 8 weeks
Adverse events: number of adverse events reported during the study period, assessed using the adverse event reporting log
Time frame: Through study completion, an average of two months
Qualitative feedback on intervention acceptability assessed using semi-structured participant interviews
Time frame: At the end of the intervention, 8 weeks
Knee pain as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index pain subscale
Knee pain will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index pain subscale. Each item is rated on a Likert scale of 0 (none pain) to 4 (extreme pain).
Time frame: Baseline and 8 weeks (at the end of the intervention)
Pain intensity as assessed using the Numerical Rating Scale
Pain intensity will be evaluated using the one-item Numerical Rating Scale, ranging from 0 (no pain) to 10 (the most imaginable pain).
Time frame: Baseline and 8 weeks (at the end of the intervention)
Stiffness as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index stiffness subscale
Stiffness will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index stiffness subscale. Each item is rated on a Likert scale of 0 (none) to 4 (extreme). A higher total score indicates more severe stiffness.
Time frame: Baseline and 8 weeks (at the end of the intervention)
Physical function as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index physical function subscale
Physical function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index physical function subscale. Each item is rated on a Likert scale of 0 (none) to 4 (extreme). A higher total score indicates more severe physical dysfunction.
Time frame: Baseline and 8 weeks (at the end of the intervention)
Symptomatic knee OA as assessed using the sit-to-stand dynamics index
Symptomatic knee OA will be assessed using the sit-to-stand dynamics index. The sit-to-stand dynamics index ranges from 0 to 1, with 1 representing the highest risk.
Time frame: Baseline and 8 weeks (at the end of the intervention)
Depression as assessed using the Patient Health Questionnaire
Depression will be assessed using the Patient Health Questionnaire. Threshold total scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively.
Time frame: Baseline and 8 weeks (at the end of the intervention)
Insomnia as assessed using the Insomnia Severity Index
Insomnia will be as assessed using the Insomnia Severity Index. Each item is rated on a Likert scale from 0 to 4, with higher total score indicating severer insomnia.
Time frame: Baseline and 8 weeks (at the end of the intervention)
Loneliness as assessed using the De Jong Giverveld Loneliness Scale
Loneliness will be as assessed using the De Jong Giverveld Loneliness Scale. The total score ranges from 0 to 6, with higher scores indicating higher levels of loneliness.
Time frame: Baseline and 8 weeks (at the end of the intervention)
Quality of life as assessed using the Short Form 12 Health Survey
Quality of life will be as assessed using the Short Form 12 Health Survey. Scores on the scale range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Time frame: Baseline and 8 weeks (at the end of the intervention)
Exercise adherence as assessed using the Exercise Adherence Rating Scale
Exercise adherence will be assessed using the Exercise Adherence Rating Scale. All items are rated on a Likert scale from 0 (completely agree) to 4 (completely disagree). Higher total scores indicate better adherence to prescribed exercise.
Time frame: Baseline and 8 weeks (at the end of the intervention)
Social support as assessed using the Social Support Questionnaire
Social support will be assessed using the Social Support Questionnaire. The questionnaire measures the number of social support and the satisfaction of social support, with ratings from 1 (very dissatisfied) and 6 (very satisfied).
Time frame: Baseline and 8 weeks (at the end of the intervention)
Mindfulness as assessed using the Mindful Attention Awareness Scale
Mindfulness will be assessed using the Mindful Attention Awareness Scale. Each item is rated on a Likert scale from 1 (almost always) to 6 (rarely), with higher scores indicating greater levels of mindfulness.
Time frame: Baseline to 8 weeks (at the end of the intervention)
Heart rate variability as assessed using the Polar H10 chest strap
Time frame: Baseline to 8 weeks (at the end of the intervention)
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Plan to share: No
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The Hong Kong Polytechnic University