ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Trapeziometacarpal Osteoarthritis, Thumb Osteoarthritis, Carpometacarpal Osteoarthritis, Thumb Basal Joint Osteoarthritis. Basic parameters: 25 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ICF-Based Biopsychosocial Assessment With Artificial Intelligence-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model
Overview
Trapeziometacarpal osteoarthritis (TMC OA) is a common condition affecting the base of the thumb that causes pain, weakness, and difficulty with daily hand use. Current clinical assessment often focuses on physical findings alone, without considering psychological and social factors that also influence patient outcomes. This study has three objectives organized as interrelated work packages: OBJECTIVE 1 (Clinical Assessment): To comprehensively assess individuals with TMC OA using the International Classification of Functioning, Disability and Health (ICF) framework. This includes evaluating pain, joint mobility, grip strength, daily activity limitations, social participation, psychological factors (anxiety, depression, fear of movement, pain beliefs), and environmental factors (family support, ergonomic adaptations). OBJECTIVE 2 (AI Knowledge Evaluation): To compare the medical knowledge performance of four large language models (Claude, ChatGPT, Gemini, LLaMA) in answering clinical questions about TMC OA, using criteria such as accuracy, reproducibility, comprehensiveness, clinical relevance, and readability. OBJECTIVE 3 (AI-Based Prediction): To analyze whether the best-performing large language model can predict multidimensional ICF-based patient profiles using only a limited set of core clinical parameters.
Detailed description
This research consists of three independent but interrelated work packages with different methods and targets.
Work Package 1 (Clinical Data Collection and ICF-Based Profile Analysis): Participants with TMC OA will undergo a single face-to-face comprehensive assessment using a cross-sectional design. The assessment battery is structured according to the ICF framework and covers five domains: (a) Body Structure/Function: pain, joint mobility, grip and pinch strength, joint stability, and OA staging; (b) Activity: daily activity limitations and pain-activity patterns (avoidance, overdoing, pacing); (c) Participation: social, domestic, and occupational participation; (d) Personal Factors: pain beliefs, coping strategies, kinesiophobia, anxiety, and depression; (e) Environmental Factors: family support and ergonomic adaptations.
Work Package 2 (Comparison of Large Language Models' Clinical Knowledge Performance): Four large language models (Claude, ChatGPT, Gemini, LLaMA) will be queried with questions frequently encountered in the TMC OA domain. Responses will be evaluated by subject matter experts using five criteria: accuracy, reproducibility (same questions repeated two times), comprehensiveness, clinical relevance, and readability (health literacy appropriateness).
Work Package 3 (LLM-Based Predictive Profile Modeling): The best-performing LLM identified in WP2 will be provided with core clinical predictors from WP1 data. The model's predictions for multidimensional ICF-based patient profiles will be compared against actual assessment results using established agreement and performance metrics.
Sample size: Based on a priori power analysis (alpha=0.05, power=0.80, effect size=0.131), a minimum of 93 participants is required.
Primary outcome measures
- Grip Strength [Time frame: Baseline (single assessment at enrollment)]
- Pinch Strength [Time frame: Baseline (single assessment at enrollment)]
- Thumb Opposition (Kapandji Score) [Time frame: Baseline (single assessment at enrollment)]
- Pain Intensity [Time frame: Baseline (single assessment at enrollment)]
- Pain Duration [Time frame: Baseline (single assessment at enrollment)]
- Radiographic Severity (Eaton-Littler Stage) [Time frame: Baseline (single assessment at enrollment)]
- Radial Subluxation Ratio [Time frame: Baseline (single assessment at enrollment)]
- Upper Extremity Disability (QuickDASH) [Time frame: Baseline (single assessment at enrollment)]
- Hand Disability (Turkish Thumb Disability Index - TDX) [Time frame: Baseline (single assessment at enrollment)]
- Joint Hypermobility (Beighton Score) [Time frame: Baseline (single assessment at enrollment)]
Secondary outcome measures (5)
- Correlations Between Pain-Activity Patterns and Clinical Variables [Time frame: Baseline (single assessment at enrollment)]
- Kinesiophobia Level (Tampa Kinesiophobia Scale) [Time frame: Baseline (single assessment at enrollment).]
- Pain Beliefs Profile (Pain Beliefs Questionnaire) [Time frame: Baseline (single assessment at enrollment)]
- Anxiety and Depression (Hospital Anxiety and Depression Scale) [Time frame: Baseline (single assessment at enrollment).]
- Pain Coping Strategies (Pain Coping Questionnaire) [Time frame: Baseline (single assessment at enrollment)]
Eligibility criteria
Inclusion criteria
- Diagnosis of trapeziometacarpal osteoarthritis (TMC OA) confirmed by an orthopedic surgeon and/or hand surgeon
- TMC OA-related symptoms persisting for more than 3 months
- Aged between 25 and 74 years
- Literate in Turkish
- Adequate cognitive function (Mini-Mental State Examination score of 25 or above)
- No other chronic systemic disease (e.g., rheumatoid arthritis, chronic diabetes, cardiovascular disease, chronic hepatitis)
- Voluntary participation with signed informed consent
Exclusion criteria
- Unwillingness to participate
- Presence of a different orthopedic condition or prior surgery involving the thumb on the unilateral upper extremity
- Uncontrolled systemic diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system disease, history of stroke)
- Diagnosis of any major psychopathology and currently receiving psychiatric or psychological treatment
- Pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Hand Surgery Rehabil — Ankara
Identifiers
NCT: NCT07458971 · FTREK25/168