CClinicalTrials.gg
Enrolling by invitationNCT07843784C-MPPMUpdated Sep 28, 2026

Chatbot-based Pain Management for People With Knee Osteoarthritis

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

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Knee Osteoarthritis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    The 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).

    Behavioral: The C-MPPM intervention

  • Active comparator
    Online 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.

    Behavioral: Online education

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.

05

What researchers measure

Primary outcomes

  1. 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

  2. Randomisation rate: percentage of consenting participants who are randomised, assessed using the study randomization log

    Time frame: Baseline

  3. 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

  4. Attendance rate: percentage of required practice sessions completed, assessed using the study practice log

    Time frame: At the end of the intervention, 8 weeks

  5. 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

  6. Qualitative feedback on intervention acceptability assessed using semi-structured participant interviews

    Time frame: At the end of the intervention, 8 weeks

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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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Study locations

1 site
  • The Hong Kong Polytechnic University
    Hong Kong, Hong Kong, Hong Kong
07

References and documents

Study documents

  • Informed consent form · Jul 14, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07843784
Lead sponsor
The Hong Kong Polytechnic University
Responsible party
Sponsor
First posted
Sep 28, 2026
Start date
Sep 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Sep 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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