Knee Osteoarthritis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALThe C-MPPM intervention
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).
BEHAVIORALOnline education
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.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or above * Having knee OA according to the American College of Rheumatology clinical criteria (Skou et al., 2020) * Had symptoms of knee OA pain for at least three months * Having moderate or greater pain (the numeric rating scale score ≥ 4) * Having a smartphone/computer, internet access, and a WhatsApp account * Understand Cantonese and informed consent
Exclusion criteria
* Having clinically diagnosed cognitive impairment or severe memory loss * Having clinically diagnosed psychotic condition(s) * Had a total joint replacement knee/hip surgery (or on a waiting list), other knee/hip surgery, meniscus tear, or anterior cruciate ligament tear in the past 6 months * Had an intra-articular injection in the past 3 months or scheduled during the study period * Having a serious or terminal illness as indicated by referral to hospice or palliative care * Having hearing, verbal communication, and vision problems * Medically unfit for or currently engaging in exercise/psychosocial interventions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment rate: percentage of eligible individuals approached who provide informed consent, assessed using the recruitment screening log | 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 | Baseline |
| Retention rate: percentage of consenting participants who complete the study, assessed using the study retention log | Through study completion, an average of two months |
| Attendance rate: percentage of required practice sessions completed, assessed using the study practice log | 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 | Through study completion, an average of two months |
| Qualitative feedback on intervention acceptability assessed using semi-structured participant interviews | At the end of the intervention, 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee pain as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index pain subscale | Baseline and 8 weeks (at the end of the intervention) | 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). |
| Pain intensity as assessed using the Numerical Rating Scale | Baseline and 8 weeks (at the end of the intervention) | Pain intensity will be evaluated using the one-item Numerical Rating Scale, ranging from 0 (no pain) to 10 (the most imaginable pain). |
| Stiffness as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index stiffness subscale | Baseline and 8 weeks (at the end of the intervention) | 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. |
| Physical function as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index physical function subscale | Baseline and 8 weeks (at the end of the intervention) | 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. |
| Symptomatic knee OA as assessed using the sit-to-stand dynamics index | Baseline and 8 weeks (at the end of the intervention) | 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. |
| Depression as assessed using the Patient Health Questionnaire | Baseline and 8 weeks (at the end of the intervention) | 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. |
| Insomnia as assessed using the Insomnia Severity Index | Baseline and 8 weeks (at the end of the intervention) | 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. |
| Loneliness as assessed using the De Jong Giverveld Loneliness Scale | Baseline and 8 weeks (at the end of the intervention) | 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. |
| Quality of life as assessed using the Short Form 12 Health Survey | Baseline and 8 weeks (at the end of the intervention) | 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. |
| Exercise adherence as assessed using the Exercise Adherence Rating Scale | Baseline and 8 weeks (at the end of the intervention) | 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. |
| Social support as assessed using the Social Support Questionnaire | Baseline and 8 weeks (at the end of the intervention) | 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). |
| Mindfulness as assessed using the Mindful Attention Awareness Scale | Baseline to 8 weeks (at the end of the intervention) | 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. |
| Heart rate variability as assessed using the Polar H10 chest strap | Baseline to 8 weeks (at the end of the intervention) | — |
Countries
Hong Kong
Outcome results
None listed