An interventional study of Face-to-face physiotherapy and psychological care (for hybrid arm) and WhatsApp-based AI chatbot for self-management (for hybrid and WhatsApp-only arms) in Chronic Low-back Pain (cLBP) and Non-specific Low Back Pain (NSLBP), sponsored by The Hong Kong Polytechnic University. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to evaluate whether adding a WhatsApp-based AI chatbot to standard physiotherapy and psychological care can improve self-management and outcomes in adults aged 18-65 with chronic low back pain (CLBP).
The main questions it aims to answer are:
Is it feasible and acceptable to use a WhatsApp-based AI chatbot as an adjunct to standard care in adults with CLBP? Does the addition of an AI chatbot improve pain, disability, mental health, and quality of life compared to standard care or digital self-management alone?
Researchers will compare three groups:
Standard care (face-to-face physiotherapy and education) with the AI chatbot, Standard care alone, AI chatbot alone.
Participants will:
Attend weekly sessions for 8 weeks (depending on group assignment, this may be face-to-face, digital, or both); Use a WhatsApp-based AI chatbot for personalized exercise and self-management support, gamification, and optional peer-support; Complete questionnaires and provide feedback on pain, function, mental health, and program usability at several time points; Receive onboarding and privacy safeguards for digital components.
Low back pain (LBP) is the leading cause of disability globally, with many individuals struggling to engage in self-management activities after leaving the clinic. This study aims to address these challenges by testing a new hybrid intervention that integrates face-to-face physiotherapy and psychological care with a WhatsApp-based AI chatbot for adults with chronic LBP.
The project is organized into two main stages:
Stage 1 involves co-designing and developing the intervention. Researchers will work with clinicians, digital health experts, and people living with chronic LBP to create the content and functions of the intervention manual and AI chatbot. The chatbot delivers personalized educational content, reminders, gamification features (like achievement badges), mindfulness-based stress reduction tips, and access to a moderated peer support group. Safety and privacy measures are built into the system, and the chatbot offers escalation to clinicians for safety concerns.
Stage 2 is a pilot, assessor-blinded randomized controlled trial in which 60 adults with chronic LBP will be randomly assigned to one of three groups:
An intervention group (receiving face-to-face care and the WhatsApp chatbot), A control group (face-to-face care only), or A digital-only group (WhatsApp chatbot only).
All groups follow an 8-week program. Face-to-face sessions focus on motor control, general conditioning, functional exercises, and back care education, with a prescribed home exercise program. The chatbot groups receive multiple digital touchpoints per week tailored to their symptoms, engagement, and needs. Optional peer support is available via moderated WhatsApp group chats.
The primary goals are to assess the program's feasibility, acceptability, adherence, safety, and usability, as well as to gather preliminary information about its possible benefits for pain, disability, mental health, and quality of life. Outcomes will be measured at baseline, after the 8-week program, and at 1- and 3-month follow-ups.
Findings from this study will inform the design of a larger trial and will help define best practices for integrating AI-driven digital health tools with conventional care for chronic low back pain management.
The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm receive eight weekly, face-to-face physiotherapy and psychological care sessions. In addition, they receive access to a WhatsApp-based AI chatbot for digital self-management support. The chatbot provides personalized exercise and education content, gamification features, mindfulness-based stress reduction, and access to a moderated peer support group.
Behavioral: Face-to-face physiotherapy and psychological care (for hybrid arm) · Behavioral: WhatsApp-based AI chatbot for self-management (for hybrid and WhatsApp-only arms)
Participants in this arm receive eight weekly, face-to-face physiotherapy and psychological care sessions. They do not receive any digital adjuncts, gamification, or access to the WhatsApp-based AI chatbot. Home exercise and educational handouts are provided in person.
Behavioral: Face-to-face physiotherapy and psychological care (No Digital Support) (for control arm)
Participants in this arm receive digital self-management only: a WhatsApp-based AI chatbot delivering personalized exercise and education content, gamification features, mindfulness-based stress reduction, and moderated peer support. No face-to-face physiotherapy or psychological care is provided.
Behavioral: WhatsApp-based AI chatbot for self-management (for hybrid and WhatsApp-only arms)
Eight weekly, 60-minute in-person sessions focusing on exercise, back care education, pain science, ergonomic advice, symptom monitoring, and home exercise, with brief psychological guidance.
Also known as: Physiotherapy, Psychological care
A WhatsApp-delivered AI chatbot providing personalized exercise and education content, gamification (badges/dashboard), mindfulness-based stress reduction, reminders, and optional peer support, delivered weekly for eight weeks, with clinical escalation as needed.
Also known as: Digital self-management, AI digital adjunct
Eight weekly, 60-minute in-person sessions providing physiotherapy and brief psychological guidance. Focuses on exercise, education, home exercise, and functional training. Participants do not receive any digital self-management or WhatsApp support.
Pain Intensity (Numeric Rating Scale)
Change in pain intensity measured on an 11-point Numeric Rating Scale (0 = no pain, 10 = worst possible pain).
Time frame: Baseline, 8 weeks, 12 weeks
Disability score (Roland-Morris Disability Questionnaire)
Change in disability as measured by the Roland-Morris Disability Questionnaire (RMDQ); total score ranges from 0 (no disability) to 24 (maximum disability).
Time frame: Baseline, 8 weeks (post-intervention), and 12 weeks (follow-up)
Psychological Distress (Depression, Anxiety and Stress Scale-21)
Change in psychological distress levels as measured by DASS-21. Higher scores indicate greater distress.
Time frame: Baseline, 8 weeks, 12 weeks
Global Impression of Change Scale
Change in participant-reported global impression of symptom change and treatment response using a 7-point scale (from "very much worse" to "very much improved").
Time frame: Baseline, 8 weeks, and 12 weeks
EQ-5D-5L (Chinese version)
Change in health-related quality of life (HRQOL) across five domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) as measured by the Chinese EQ-5D-5L; higher scores indicate better quality of life.
Time frame: Baseline, 8 weeks, and 12 weeks
Hong Kong - Pain Catastrophizing Scale (HK-PCS)
Change in pain catastrophizing as measured by the 13-item HK-PCS, covering rumination, magnification, and helplessness. Higher scores indicate more catastrophic thinking.
Time frame: Baseline, 8 weeks, and 12 weeks
General Self-Efficacy Scale (Chinese version)
Change in self-efficacy, measured using the 10-item General Self-Efficacy Scale. Higher scores reflect greater confidence in overcoming obstacles.
Time frame: Baseline, 8 weeks, and 12 weeks
Digital Engagement Metrics (WhatsApp)
WhatsApp read receipts, message response rates, and self-reported adherence to digital self-management content.
Time frame: Over 8 weeks
Chinese System Usability Scale
Usability of WhatsApp-delivered self-management content assessed by the 10-item Chinese System Usability Scale. Scores range from 0 (lowest) to 100 (highest usability).
Time frame: 8 weeks
Participant Satisfaction with Hybrid Delivery
Participant-reported satisfaction and perceived benefit of receiving hybrid/integrated telehealth consultations, measured via feedback forms.
Time frame: 8 weeks and 12 weeks
Plan to share: Undecided — The decision regarding sharing IPD has not yet been finalized. IPD sharing will depend on institutional policies, participant consent, and potential ethical or privacy considerations. Further information may be provided after the study is completed.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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