Chronic Low-back Pain (cLBP)NCT07902778
Hybrid mHealth for Low Back Pain
A study testing 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 people with Chronic Low-back Pain (cLBP) and Non-specific Low Back Pain (NSLBP), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain (cLBP), Non-specific Low Back Pain (NSLBP)
- What is being tested?
- Face-to-face physiotherapy and psychological care (for hybrid arm) and WhatsApp-based AI chatbot for self-management (for hybrid and WhatsApp-only arms)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Nov 2026to 2 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years
- Diagnosed with [target condition, e.g., chronic low back pain] for at least 3 months
- Able to communicate in Chinese (written and spoken)
- Access to a smartphone with WhatsApp installed
- Willing and able to attend face-to-face physiotherapy and/or use digital interventions as assigned
- Provide written informed consent
Who cannot join
- Presence of red flag symptoms or serious spinal pathology (e.g., tumor, infection, fracture)
- Previous spine surgery within the past 12 months
- Severe psychiatric disorders or active suicidal ideation
- Currently participating in other intervention studies targeting the same condition
- Inability to comply with study procedures or follow-up assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
The Hong Kong Polytechnic University
Hong Kong, Kowloon
Fadi M Al Zoubi, PhD, +85227666705, fadi.alzoubi@polyu.edu.hk
Fadi M Al Zoubi, PhD
About this study
Official title: Hybrid mHealth Care for Chronic Low Back Pain: Feasibility of a WhatsApp-Based AI Chatbot Adjunct to Face-to-Face Physiotherapy
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:
Read more
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.
Read the detailed description
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.
- Being tested
- Face-to-face physiotherapy and psychological care (for hybrid arm), WhatsApp-based AI chatbot for self-management (for hybrid and WhatsApp-only arms), Face-to-face physiotherapy and psychological care (No Digital Support) (for control arm)
- Keywords
- Chronic low back pain, Non-specific low back pain, mHealth, Mobile health, AI chatbot, WhatsApp, Digital health intervention, Physiotherapy, Self-management, Randomized controlled trial, Pain management, Telehealth
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face physiotherapy and psychological care (for hybrid arm)Behavioural
Also called Physiotherapy, Psychological care
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.
WhatsApp-based AI chatbot for self-management (for hybrid and WhatsApp-only arms)Behavioural
Also called Digital self-management, AI digital adjunct
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.
Face-to-face physiotherapy and psychological care (No Digital Support) (for control arm)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: 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) |
| Control Arm | Active comparator | 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. Receives: Behavioral: Face-to-face physiotherapy and psychological care (No Digital Support) (for control arm) |
| WhatsApp Arm | Experimental | 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. Receives: Behavioral: WhatsApp-based AI chatbot for self-management (for hybrid and WhatsApp-only arms) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (Numeric Rating Scale)
Change in pain intensity measured on an 11-point Numeric Rating Scale (0 = no pain, 10 = worst possible pain).
Measured: 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).
Measured: 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.
Measured: Baseline, 8 weeks, 12 weeks
Secondary outcomes (4)
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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 8 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion2 Nov 2027 (estimated)
- Study completion2 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back Pain (cLBP)Studies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three groups: 1. Intervention group (face-to-face physiotherapy and psychological care plus 2. WhatsApp-based AI chatbot), 2. Control group (face-to-face physiotherapy only), or 3. WhatsApp group (AI chatbot only, no in-person sessions). Each group follows the assigned intervention for 8 weeks with assessments at baseline, 8 weeks, and follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Fadi AL ZOUBI, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902778
- Sponsor's protocol ID
- HSEARS20260520007
- Other IDs
- Financial Support for Non-PAIR
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid mHealth Care for Chronic Low Back Pain: Feasibility of a WhatsApp-Based AI Chatbot Adjunct to Face-to-Face Physiotherapy
- ClinicalTrials.gov ID
- NCT07902778
- Acronym / sponsor ID
- HSEARS20260520007
- Keywords
- Chronic low back pain, Non-specific low back pain, mHealth, Mobile health, AI chatbot, WhatsApp, Digital health intervention, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 2 Nov 2027 (estimated)
- Study completion
- 2 Nov 2027 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three groups: 1. Intervention group (face-to-face physiotherapy and psychological care plus 2. WhatsApp-based AI chatbot), 2. Control group (face-to-face physiotherapy only), or 3. WhatsApp group (AI chatbot only, no in-person sessions). Each group follows the assigned intervention for 8 weeks with assessments at baseline, 8 weeks, and follow-up.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | 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. 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. |
| Control Arm | Active comparator | Behavioral: Face-to-face physiotherapy and psychological care (No Digital Support) (for control arm)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. |
| WhatsApp Arm | Experimental | Behavioral: WhatsApp-based AI chatbot for self-management (for hybrid and WhatsApp-only arms)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18-65 years
- Diagnosed with [target condition, e.g., chronic low back pain] for at least 3 months
- Able to communicate in Chinese (written and spoken)
- Access to a smartphone with WhatsApp installed
- Willing and able to attend face-to-face physiotherapy and/or use digital interventions as assigned
Key exclusion criteria (5 listed)
- Presence of red flag symptoms or serious spinal pathology (e.g., tumor, infection, fracture)
- Previous spine surgery within the past 12 months
- Severe psychiatric disorders or active suicidal ideation
- Currently participating in other intervention studies targeting the same condition
- Inability to comply with study procedures or follow-up assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face-to-face physiotherapy and psychological care (for hybrid arm)Also: Physiotherapy, Psychological careEight 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. | Behavioural | Intervention Arm |
| WhatsApp-based AI chatbot for self-management (for hybrid and WhatsApp-only arms)Also: Digital self-management, AI digital adjunctA 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. | Behavioural | Intervention Arm, WhatsApp Arm |
| Face-to-face physiotherapy and psychological care (No Digital Support) (for control arm)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. | Behavioural | Control Arm |
Primary outcome
Pain Intensity (Numeric Rating Scale)
Time frame: Baseline, 8 weeks, 12 weeks
Change in pain intensity measured on an 11-point Numeric Rating Scale (0 = no pain, 10 = worst possible pain).
Disability score (Roland-Morris Disability Questionnaire)
Time frame: Baseline, 8 weeks (post-intervention), and 12 weeks (follow-up)
Change in disability as measured by the Roland-Morris Disability Questionnaire (RMDQ); total score ranges from 0 (no disability) to 24 (maximum disability).
Psychological Distress (Depression, Anxiety and Stress Scale-21)
Time frame: Baseline, 8 weeks, 12 weeks
Change in psychological distress levels as measured by DASS-21. Higher scores indicate greater distress.
4 secondary outcomes
Global Impression of Change Scale
Time frame: Baseline, 8 weeks, and 12 weeks
EQ-5D-5L (Chinese version)
Time frame: Baseline, 8 weeks, and 12 weeks
Hong Kong - Pain Catastrophizing Scale (HK-PCS)
Time frame: Baseline, 8 weeks, and 12 weeks
General Self-Efficacy Scale (Chinese version)
Time frame: Baseline, 8 weeks, and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Chronic Low-back Pain (cLBP) and Non-specific Low Back Pain (NSLBP), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fadi M Al Zoubi, PhD (+85227666705, fadi.alzoubi@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (Numeric Rating Scale) (time frame: Baseline, 8 weeks, 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.