Chronic Musculoskeletal PainPT-AI PilotNCT07497997
PainTrain-AI Pilot: Feasibility, Usability (SUS) and Concept-Shift in Primary Care and a Specialized Setting
A study testing PainTrain-AI Behavioral Training in people with Chronic Musculoskeletal Pain, run by Francesc Valenzuela Pascual at 1 site in Spain.
Trial summary
This pilot will assess feasibility and usability (SUS) and explore concept shift (reduction of neurophysiology misconceptions) after exposure to a behavioral educational intervention (PainTrain AI), a digital clinical simulation "fenced" by evidence (RAG) for safe, non diagnostic training. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Musculoskeletal Pain
- What is being tested?
- PainTrain-AI Behavioral Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2027to Sep 2028
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health professionals in Primary Care (medicine, physiotherapy, nursing, psychology, nutrition) and specialized setting; willingness to use the platform; institutional approval.
Who cannot join
- lack of institutional access; unavailability during pilot window
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Universitat de Lleida
Lleida, Lleida, 25198
Fran, fran.valenzuela@udl.cat
Fran Valenzuela-Pascual, Dr., +34 973 702 459, fran.valenzuela@udl.cat
About this study
Official title: Feasibility and Usability of a Digital Clinical Simulation (PainTrain AI) for Chronic Pain Training in Health Professionals: A Multicenter Pilot in Primary Care (ICS) and a Specialized Comparative Setting
This pilot will assess feasibility and usability (SUS) and explore concept shift (reduction of neurophysiology misconceptions) after exposure to a behavioral educational intervention (PainTrain AI), a digital clinical simulation "fenced" by evidence (RAG) for safe, non diagnostic training. The study will be conducted in Primary Care and in a specialized comparative setting, without patient data collection. Primary endpoint: SUS score. Secondary endpoints: concept shift, adherence to micromodules, and interaction latency as friction metric. The platform does not generate clinical advice; it retrieves validated teaching content.
Read the detailed description
This feasibility pilot will evaluate the use of PainTrain AI, a behavioral educational intervention designed to improve clinical reasoning about chronic pain through simulated dialogues with virtual standardized patients. The platform uses a Retrieval Augmented Generation (RAG) safety architecture that restricts all generated responses to validated pedagogical content and does not provide clinical advice. No patient information is collected.
The study includes health professionals from Primary Care and a specialized comparative setting. Participants will complete a baseline assessment and then interact with the PainTrain AI simulation for a defined training period. Usability will be assessed using the System Usability Scale (SUS). Concept shift will be measured as the reduction in predefined neurophysiology misconceptions scored through a standardized rubric. Additional metrics include adherence to micromodules and interaction latency as indicators of technological friction.
This pilot aims to determine feasibility, acceptability, and preliminary signals of educational effectiveness to inform a future implementation trial in Primary Care. The intervention is educational only, non diagnostic, and GDPR compliant.
- Conditions
- Chronic Musculoskeletal Pain
- Being tested
- PainTrain-AI Behavioral Training
- Keywords
- chronic musculoskeletal pain, clinical simulation, digital training, educational intervention, usability (SUS), concept shift, primary care professionals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PainTrain-AI Behavioral TrainingBehavioural
PainTrain-AI is a behavioral educational intervention delivered through a digital clinical simulation platform. The system uses a retrieval-augmented generation (RAG) safety architecture to ensure that all responses are generated only from validated pedagogical content. Participants engage in simulated dialogues with virtual standardized patients to practice biopsychosocial reasoning about chronic pain. The intervention is non-diagnostic, does not provide clinical advice, and does not involve patient data. All participants receive the same intervention.
| Study group | Role | What they receive |
|---|---|---|
| PainTrain-AI Behavioral Training | Experimental | Participants in this arm will receive the behavioral educational intervention PainTrain-AI, a digital clinical simulation that uses a retrieval-augmented generation (RAG) safety architecture to deliver evidence-based teaching content. The platform provides simulated dialogues with virtual standardized patients to train biopsychosocial reasoning about chronic pain. All participants receive the same intervention; there is no control group. Receives: Behavioral: PainTrain-AI Behavioral Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability (SUS, 0-100)
Usability will be assessed using the System Usability Scale (SUS), a validated 10-item questionnaire that yields a score from 0 to 100. Higher scores indicate better usability. Participants will complete the SUS after interacting with the PainTrain-AI educational simulation for the predefined training period. The primary feasibility criterion is achieving a mean SUS score ≥75, indicating good usability.
Measured: 4-8 weeks after onboarding
Secondary outcomes (3)
Concept Shift
Concept-shift will be assessed as the change in the proportion of predefined misconceptions about pain neurophysiology identified in a standardized scoring rubric. Participants will complete a brief conceptual test before and after exposure to the PainTrain-AI educational simulation. Concept-shift is calculated as the reduction in incorrect or outdated statements related to chronic pain mechanisms. Higher improvement reflects better conceptual understanding. No patient data are involved.
Measured: 4-8 weeks.
Adherence
Adherence will be measured as the proportion of scheduled training modules or simulation sessions that each participant completes within the study period. Adherence is calculated as the percentage of completed sessions relative to the total number of modules assigned. Higher values indicate greater engagement with the PainTrain-AI educational intervention. No patient data are involved.
Measured: 4-8 weeks
Latency/friction
Latency will be measured as the average system response time (in seconds) during user interactions with the PainTrain-AI digital simulation. Latency is calculated automatically from platform logs as the time elapsed between a user input and the system's generated response. Higher latency indicates greater technological friction. This outcome evaluates technical feasibility and user experience. No patient data are involved.
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francesc Valenzuela Pascual
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francesc Valenzuela Pascual, Universitat de Lleida
- Investigators
- Fran Valenzuela-Pascual, Dr., Principal investigator, Institut de Recerca Biomèdica de Lleida (IRBLleida) / Universitat de Lleida (UdL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497997
- Sponsor's protocol ID
- PT-AI-PILOT-2026
- Acronym
- PT-AI Pilot
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared because the study does not involve patient data or clinical individual-level information. Only anonymized usage datasets and aggregated concept-shift scores may be shared according to a FAIR plan (anonymized logs + codebooks), deposited in public repositories after embargo per grant policy.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Usability of a Digital Clinical Simulation (PainTrain AI) for Chronic Pain Training in Health Professionals: A Multicenter Pilot in Primary Care (ICS) and a Specialized Comparative Setting
- ClinicalTrials.gov ID
- NCT07497997
- Acronym / sponsor ID
- PT-AI Pilot / PT-AI-PILOT-2026
- Conditions
- Chronic Musculoskeletal Pain
- Keywords
- chronic musculoskeletal pain, clinical simulation, digital training, educational intervention, usability (SUS), concept shift, primary care professionals
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Francesc Valenzuela PascualUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 27 Mar 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.
This pilot will assess feasibility and usability (SUS) and explore concept shift (reduction of neurophysiology misconceptions) after exposure to a behavioral educational intervention (PainTrain AI), a digital clinical simulation "fenced" by evidence (RAG) for safe, non diagnostic training. The study will be conducted in Primary Care and in a specialized comparative setting, without patient data collection. Primary endpoint: SUS score. Secondary endpoints: concept shift, adherence to micromodules, and interaction latency as friction metric. The platform does not generate clinical advice; it retrieves validated teaching content.
Detailed description
This feasibility pilot will evaluate the use of PainTrain AI, a behavioral educational intervention designed to improve clinical reasoning about chronic pain through simulated dialogues with virtual standardized patients. The platform uses a Retrieval Augmented Generation (RAG) safety architecture that restricts all generated responses to validated pedagogical content and does not provide clinical advice. No patient information is collected.
The study includes health professionals from Primary Care and a specialized comparative setting. Participants will complete a baseline assessment and then interact with the PainTrain AI simulation for a defined training period. Usability will be assessed using the System Usability Scale (SUS). Concept shift will be measured as the reduction in predefined neurophysiology misconceptions scored through a standardized rubric. Additional metrics include adherence to micromodules and interaction latency as indicators of technological friction.
This pilot aims to determine feasibility, acceptability, and preliminary signals of educational effectiveness to inform a future implementation trial in Primary Care. The intervention is educational only, non diagnostic, and GDPR compliant.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PainTrain-AI Behavioral Training | Experimental | Behavioral: PainTrain-AI Behavioral TrainingParticipants in this arm will receive the behavioral educational intervention PainTrain-AI, a digital clinical simulation that uses a retrieval-augmented generation (RAG) safety architecture to deliver evidence-based teaching content. The platform provides simulated dialogues with virtual standardized patients to train biopsychosocial reasoning about chronic pain. All participants receive the same intervention; there is no control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Health professionals in Primary Care (medicine, physiotherapy, nursing, psychology, nutrition) and specialized setting; willingness to use the platform; institutional approval.
Key exclusion criteria (1 listed)
- lack of institutional access; unavailability during pilot window
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 |
|---|---|---|
| PainTrain-AI Behavioral TrainingPainTrain-AI is a behavioral educational intervention delivered through a digital clinical simulation platform. The system uses a retrieval-augmented generation (RAG) safety architecture to ensure that all responses are generated only from validated pedagogical content. Participants engage in simulated dialogues with virtual standardized patients to practice biopsychosocial reasoning about chronic pain. The intervention is non-diagnostic, does not provide clinical advice, and does not involve patient data. All participants receive the same intervention. | Behavioural | PainTrain-AI Behavioral Training |
Primary outcome
Usability (SUS, 0-100)
Time frame: 4-8 weeks after onboarding
Usability will be assessed using the System Usability Scale (SUS), a validated 10-item questionnaire that yields a score from 0 to 100. Higher scores indicate better usability. Participants will complete the SUS after interacting with the PainTrain-AI educational simulation for the predefined training period. The primary feasibility criterion is achieving a mean SUS score ≥75, indicating good usability.
3 secondary outcomes
Concept Shift
Time frame: 4-8 weeks.
Adherence
Time frame: 4-8 weeks
Latency/friction
Time frame: 4-8 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 2 Apr 2026.
- Individual participant dataSharing planned: No. No IPD will be shared because the study does not involve patient data or clinical individual-level information. Only anonymized usage datasets and aggregated concept-shift scores may be shared according to a FAIR plan (anonymized logs + codebooks), deposited in public repositories after embargo per grant policy.
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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.
Fran Valenzuela-Pascual, Dr. principal investigator
Institut de Recerca Biomèdica de Lleida (IRBLleida) / Universitat de Lleida (UdL)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PainTrain-AI Behavioral Training in people with Chronic Musculoskeletal Pain, run by Francesc Valenzuela Pascual at 1 site in Spain.
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 1 inclusion and 1 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 2 Apr 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 Spain. 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 Fran Valenzuela-Pascual, Dr (+34 973 702 459, fran.valenzuela@udl.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability (SUS, 0-100) (time frame: 4-8 weeks after onboarding). 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 2 Apr 2026.