ICF-Based Biopsychosocial Assessment With Artificial Intelligence-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model
Trial ID: NCT07458971
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2026-02
Completion date: 2027-07
Sponsor: Hacettepe University
Conditions: Trapeziometacarpal Osteoarthritis; Thumb Osteoarthritis; Carpometacarpal Osteoarthritis; Thumb Basal Joint Osteoarthritis
Locations: Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Hand Surgery Rehabilitation Unit
Countries: Turkey (Türkiye)
Enrollment: 93
Age range: 25 Years - 74 Years
Sex: ALL

Summary:
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.

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

Outcomes:
Grip Strength; Pinch Strength; Thumb Opposition (Kapandji Score); Pain Intensity; Pain Duration; Radiographic Severity (Eaton-Littler Stage); Radial Subluxation Ratio; Upper Extremity Disability (QuickDASH); Hand Disability (Turkish Thumb Disability Index - TDX); Joint Hypermobility (Beighton Score); Thumb Joint Range of Motion; Provocative Tests; Environmental Factors: Social Support and Ergonomic Adaptations; Emotional Status (Hospital Anxiety and Depression Scale); Kinesiophobia Level (Tampa Scale of Kinesiophobia); Pain-Activity Patterns (Patterns of Activity Measure-Pain).; Pain Beliefs Profile (Pain Beliefs Questionnaire); Pain Coping Strategies (Pain Coping Questionnaire).; Large Language Model Clinical Knowledge Accuracy; Large Language Model Response Reproducibility; Large Language Model Content Comprehensiveness; Large Language Model Clinical Relevance; Large Language Model Readability Score; LLM Prediction Accuracy for Continuous ICF Profiles; LLM Prediction Accuracy for Categorical ICF Profiles