Chatbot-based Pain Management for People With Knee Osteoarthritis

NCT07843784 | Enrolling By Invitation

• 1 other identifier: P0058839
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (13)

• 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)

• Pain intensity as assessed using the Numerical Rating Scale

  Baseline and 8 weeks (at the end of the intervention)

• Stiffness as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index stiffness subscale

  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

  Baseline and 8 weeks (at the end of the intervention)

• Symptomatic knee OA as assessed using the sit-to-stand dynamics index

  Baseline and 8 weeks (at the end of the intervention)

Study Arms (2)

The C-MPPM intervention

EXPERIMENTAL

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

Online education

ACTIVE COMPARATOR

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

The C-MPPM intervention BEHAVIORAL

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 C-MPPM intervention

Online education BEHAVIORAL

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.

Online education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: September 28, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)