Person-Centred AI Support in Interdisciplinary Rehabilitation for Chronic Pain

NCT07081737 | Not Yet Recruiting DMC

• 1 other identifier: 2023-04532-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This cluster randomized controlled trial evaluates whether a person-centred, AI-supported Clinical Decision Support System (CDSS) can improve outcomes and cost-effectiveness in interdisciplinary rehabilitation for people with complex chronic pain. The CDSS is designed to assist clinicians in making personalized treatment decisions within standard interdisciplinary treatment (IDT). It has been developed using machine learning models trained on real-world data from over 100,000 patients in the Swedish Quality Registry for Pain Rehabilitation (SQRP), linked to several national registers, including the National Patient Register, the Prescribed Drug Register, the Social Insurance Agency database (MiDAS), and the Cause of Death Register. This enables individualized predictions of treatment outcomes, work ability, and healthcare utilization. The trial includes 400 adult patients with chronic pain, enrolled at 20 IDT clinics randomized to either CDSS-supported or standard IDT. The study has three phases: feasibility, effectiveness, and implementation. The primary outcome is a patient-prioritized composite single-index of health-related well-being, based on domains such as pain, sleep, physical and mental health, emotional distress, and work ability. Patients prioritize these domains together with their clinical team, enabling a person-centred assessment. Secondary outcomes include HRQoL (EQ-5D, SF-36), emotional distress (HADS), and work ability (WAI), measured at baseline, post-treatment, 6- and 12-month follow-up. A parallel mixed-methods process evaluation will examine implementation outcomes such as usability, clinician adherence, and workflow integration, using logs, surveys (e.g., S-NoMAD), and interviews. Normalization Process Theory guides the analysis. Cost-utility will be assessed using QALYs and ICERs from a societal perspective, with long-term projections using simulation models. Results will be reported in peer-reviewed publications.

Conditions

Pain, Chronic; Chronic Pain, Widespread; Pain Management

Keywords

chronic pain; prediction; Artificial Intelligence; Interdisciplinary pain rehabilitation; Machine learning; Clinical Decision Support System (CDSS)

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Patient-Prioritized Health-Related Well-being Composite at 12 Months

  A person-centred composite score based on eight validated domains: pain intensity (NRS; 0-10), sleep problems (ISI; 0-28), physical health (SF-36 PF; 0-100), mental health (SF-36 MH; 0-100), depression and anxiety (HADS-A/D; 0-21), work ability (WAI single item; 0-10), and pain interference (single item; 0-10). At baseline, participants prioritize these domains together with the interdisciplinary treatment (IDT) team. The Clinical Decision Support System (CDSS) stores these weights. Each domain is normalized to 0-100 and combined into a weighted composite. Higher scores indicate better health-related well-being. Although composed of several scales, the outcome is reported as a single, aggregated primary measure.

  (1) Baseline, (2) up to 18 weeks after baseline*, and (3) 12-month follow-up. (*Most programs last 6-8 weeks, but some clinics extend to 18 weeks (fewer sessions/week) due to existing routine practice).

Secondary Outcomes (13)

• Change from Baseline in Pain Intensity (NRS) at 12 Months

  (1) Baseline, (2) up to 18 weeks after baseline*, and (3) 12-month follow-up. (*Most programs last 6-8 weeks, but some clinics extend to 18 weeks (fewer sessions/week) due to existing routine practice).

• Change from Baseline in Sleep Problems Measured by the Insomnia Severity Index (ISI) at 12 Months

  (1) Baseline, (2) up to 18 weeks after baseline*, and (3) 12-month follow-up. (*Most programs last 6-8 weeks, but some clinics extend to 18 weeks (fewer sessions/week) due to existing routine practice).

• Change from Baseline in Physical Health Functioning (SF-36 PF) at 12 Months

  (1) Baseline, (2) up to 18 weeks after baseline*, and (3) 12-month follow-up. (*Most programs last 6-8 weeks, but some clinics extend to 18 weeks (fewer sessions/week) due to existing routine practice).

• Change from Baseline in Mental Health (SF-36 MH) at 12 Months

  (1) Baseline, (2) up to 18 weeks after baseline*, and (3) 12-month follow-up. (*Most programs last 6-8 weeks, but some clinics extend to 18 weeks (fewer sessions/week) due to existing routine practice).

• Change from Baseline in Emotional Distress Measured by the Hospital Anxiety and Depression Scale (HADS) at 12 Months

  (1) Baseline, (2) up to 18 weeks after baseline*, and (3) 12-month follow-up. (*Most programs last 6-8 weeks, but some clinics extend to 18 weeks (fewer sessions/week) due to existing routine practice).

Other Outcomes (8)

• Change in Sickness Absence (Register-Based) at 12 Months

  From 5 years before baseline to 5 years after the 12-month follow-up.

• Change in Total Prescribed Medication Volume (Register-Based) at 12 Months

  From 5 years before baseline to 5 years after the 12-month follow-up.

• Change in Comorbidity Burden Over Time

  From 5 years before baseline to 5 years after the 12-month follow-up.

Study Arms (2)

Interdisciplinary treatment (IDT) + Clinical Decision Support System (CDSS)

EXPERIMENTAL

Participants in this arm receive standard interdisciplinary treatment (IDT) for complex chronic pain, supported by a Clinical Decision Support System (CDSS). The CDSS provides individualized prognostic and predictive outputs using advanced AI-clustered models trained on linked national registry data. Clinicians access the CDSS through a secure interface integrated into clinical workflows, offering data-driven support for person-centred treatment planning and goal setting. The intervention is designed to enhance decision-making, treatment precision, and long-term outcomes such as work ability, well-being, and quality of life. The CDSS is used by the care team prior to and during the rehabilitation program.

Other: Interdisciplinary treatment (IDT) + Clinical Decision Support System (CDSS)

Interdisciplinary treatment (IDT)

ACTIVE COMPARATOR

Participants in this control-arm receive standard interdisciplinary treatment (IDT) for complex chronic pain. IDT is delivered by a coordinated team of healthcare professionals-typically including physicians, psychologists, physiotherapists, and occupational therapists-and is based on evidence-informed rehabilitation protocols. The program emphasizes biopsychosocial assessment, goal setting, and individually tailored interventions aimed at improving function, coping, and quality of life. No use of the Clinical Decision Support System (CDSS) is included in this arm.

Other: Interdisciplinary treatment (IDT)

Interventions

Interdisciplinary treatment (IDT) + Clinical Decision Support System (CDSS) OTHER

Interdisciplinary treatment (IDT) combined with Clinical Decision Support System (CDSS)

Interdisciplinary treatment (IDT) + Clinical Decision Support System (CDSS)

Interdisciplinary treatment (IDT) OTHER

Interdisciplinary treatment (IDT)

Interdisciplinary treatment (IDT)

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 67 years
• Diagnosed with chronic non-malignant pain persisting longer than 3 months
• Pain condition includes, but is not limited to: fibromyalgia, widespread pain, back pain, neck pain, or shoulder pain
• Eligible for and referred to interdisciplinary rehabilitation (IDT) at a participating clinic
• Willing and able to participate in digital assessment and follow-up procedures
• Able to communicate and complete study materials in Swedish
• Provides written informed consent

You may not qualify if:

• Pain caused by malignancy or cancer-related treatment
• Pain caused by systemic diseases such as rheumatoid arthritis, lupus, or other autoimmune or inflammatory conditions
• Severe psychiatric conditions interfering with study participation (e.g., untreated psychosis or severe depression requiring immediate psychiatric care)
• Documented cognitive impairment limiting ability to understand study participation or complete self-reported measures
• Currently enrolled in another interventional clinical trial that may confound the outcomes of this study
• Not expected to remain in the clinic's follow-up system for the duration of the study

Sponsors & Collaborators

• Bjorn Ang: lead
• Göteborg University: collaborator
• Forte: collaborator
• Dalarna County Council, Sweden: collaborator
• Karolinska Institutet: collaborator
• The Swedish Research Council: collaborator

Study Sites (1)

Dalarna University

Falun, Dalarna County, 79188, Sweden

Location

Related Publications (39)

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Related Links

• Research project/group

MeSH Terms

Conditions

Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Björn O Äng, Professor

  Dalarna University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony Bohman, Ass. Professor

CONTACT

+46702996263; tbo@du.se

Marika Hagelberg, MSc

CONTACT

+4623778418; mhb@du.se

Study Design

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

Model Details: A two-armed, multi-site cluster randomized controlled trial (2026-2029) will be conducted across 20 interdisciplinary rehabilitation clinics. Clinics are randomized to standard interdisciplinary treatment (IDT) with or without a Clinical Decision Support System (CDSS). The design follows the UK Medical Research Council (MRC) framework for complex interventions and includes a pilot RCT, a full-scale effectiveness and cost-utility trial, and a concurrent process evaluation. Patients are recruited via routine care. Outcomes are assessed at baseline, post-IDT, and 12-month follow-up. Primary outcome: a patient-prioritized composite of health-related well-being. Secondary outcomes: SF-36, EQ-5D, HADS, WAI, and register-based data on sickness absence and medication (followed for 5 years). Cost-utility (QALYs, ICERs) and implementation (using Normalization Process Theory) are evaluated.

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: July 23, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Individual participant data (IPD) and supporting documentation will be made available beginning 12 months after publication of the primary results. Access will be granted upon reasonable request and subject to approval by the principal investigator and relevant ethical and legal review, in accordance with Swedish data protection regulations (e.g., GDPR).
• Access Criteria: Access to de-identified individual participant data (IPD) and supporting documentation may be granted to qualified researchers affiliated with academic or healthcare institutions, for ethically approved research purposes. Requests must include a detailed research proposal and ethical approval from an appropriate Swedish or EU-recognized ethics review board. All requests will be reviewed by the principal investigator and the responsible data controller at the host institution. A data sharing agreement must be signed. Data access will be provided through secure transfer mechanisms, in full compliance with the Swedish Patient Data Act (PDL) and the General Data Protection Regulation (GDPR).

Locations

SE (1)