ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model

Condition(s) studied

Study 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 performance of four large language models (GPT-5.2, Claude Opus 4.6, Gemini 2.5 Pro, LLaMA 4 Maverick) in answering patient questions about TMC OA, and to test whether adding a clinician-oriented system prompt changes that performance. Each question is submitted under two prompting conditions (zero-shot and clinician-oriented system prompt) and responses are rated by blinded experts for accuracy, comprehensiveness and clinical relevance, with readability assessed by automated indices.

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

Primary outcome measure(s)

• Grip Strength — Baseline (single assessment at enrollment)
  Measured using a Jamar dynamometer. The participant performs the test in a seated position with the elbow flexed at 90 degrees. Unit of Measure: Kilograms
• Pinch Strength — Baseline (single assessment at enrollment)
  Measured using a pinchmeter to assess tip-to-tip and key pinch strength. Unit of Measure: Kilograms
• Thumb Opposition (Kapandji Score) — Baseline (single assessment at enrollment)
  Assessment of thumb opposition using the Kapandji score, which ranges from 0 to 10. Higher scores indicate better thumb opposition and mobility.
• Pain Intensity — Baseline (single assessment at enrollment)
  Measured using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
• Pain Duration — Baseline (single assessment at enrollment)
  Total duration of thumb pain reported by the participant.
• Radiographic Severity (Eaton-Littler Stage) — Baseline (single assessment at enrollment)
  Evaluation of the trapeziometacarpal joint osteoarthritis stage based on the Eaton-Littler classification (Stages I through IV).
• Radial Subluxation Ratio — Baseline (single assessment at enrollment)
  Radiographic measurement of the radial subluxation of the metacarpal base on the trapezium.
• Upper Extremity Disability (QuickDASH) — Baseline (single assessment at enrollment)
  Measured using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire. The score ranges from 0 to 100, where higher scores indicate greater disability and symptoms.
• Hand Disability (Turkish Thumb Disability Index - TDX) — Baseline (single assessment at enrollment)
  Assessment of thumb-related disability. Scores range from 0 to 100, with higher scores indicating greater functional impairment.
• Joint Hypermobility (Beighton Score) — Baseline (single assessment at enrollment)
  Assessment of generalized joint laxity using the Beighton score. The total score ranges from 0 to 9, where higher scores indicate greater hypermobility.
• Thumb Joint Range of Motion — Baseline (single assessment at enrollment)
  Active range of motion of the thumb joints measured using a goniometer. Unit of Measure: Degrees
• Provocative Tests — Baseline (single assessment at enrollment)
  Clinical assessment using metacarpal adduction and extension tests to provoke symptoms. Presence or absence of pain (Binary: Yes/No)
• Environmental Factors: Social Support and Ergonomic Adaptations — Baseline (single assessment at enrollment)
  Qualitative assessment of the participant's family support and the presence of ergonomic adaptations in their daily environment.
• Emotional Status (Hospital Anxiety and Depression Scale) — Baseline (single assessment at enrollment)
  Measured using the Hospital Anxiety and Depression Scale (HADS), which consists of two subscales: Anxiety (HADS-A) and Depression (HADS-D). Each subscale ranges from 0 to 21, where higher scores indicate greater levels of anxiety or depression (worse outcome).
• Kinesiophobia Level (Tampa Scale of Kinesiophobia) — Baseline (single assessment at enrollment)
  Measured using the 17-item Tampa Scale of Kinesiophobia (TSK-17) to assess the fear of movement or re-injury. Total scores range from 17 to 68, where higher scores indicate greater kinesiophobia (worse outcome).
• Pain-Activity Patterns (Patterns of Activity Measure-Pain). — Baseline (single assessment at enrollment).
  Measured using the Patterns of Activity Measure-Pain (POAM-P) questionnaire to classify participants into three patterns: avoidance, overdoing, and pacing. Each subscale score indicates the frequency of that specific activity pattern. Higher scores on each subscale indicate a more frequent use of that specific activity pattern.
• Pain Beliefs Profile (Pain Beliefs Questionnaire) — Baseline (single assessment at enrollment).
  Assessed using the Pain Beliefs Questionnaire (PBQ), which evaluates two dimensions: Organic and Psychological pain beliefs. Scores range from 1 to 6 for each subscale, where higher scores indicate a stronger belief in that specific dimension (e.g., higher organic scores mean a stronger belief that pain is due to physical damage).
• Pain Coping Strategies (Pain Coping Questionnaire). — Baseline (single assessment at enrollment).
  Measured using the Pain Coping Questionnaire (PCQ) to assess the frequency of different coping strategies (e.g., information seeking, problem solving, distraction). Higher scores indicate a more frequent use of the respective coping strategy.
• Large Language Model Clinical Knowledge Accuracy — Baseline (single assessment during the data collection period)
  Accuracy of responses from four large language models to 40 patient-derived questions, each submitted under two prompting conditions (320 responses). Two blinded experts rate each response on an anchored 5-point scale (1 = mostly incorrect or potentially harmful, 5 = no factual error); criterion-level disagreements of two points or more are resolved by a third blinded expert. Higher scores indicate greater accuracy.
• Large Language Model Content Comprehensiveness — Baseline (single assessment at enrollment)
  Coverage of the elements a specialist would expect in an answer, rated by two blinded experts on an anchored 5-point scale (1 = question not genuinely answered, 5 = all essential elements covered), with third-expert arbitration of disagreements of two points or more.
• Large Language Model Clinical Relevance — Baseline (single assessment)
  Alignment of the response with the question asked, rated on an anchored 5-point scale (1 = unrelated, 5 = precisely and fully answers the question), with third-expert arbitration.
• Large Language Model Readability Score — Baseline (calculated immediately after response generation)
  Readability of generated responses, computed automatically as the Flesch Reading Ease score and the Flesch-Kincaid Grade Level. Higher Flesch Reading Ease scores indicate easier text; higher Flesch-Kincaid values indicate a higher required reading grade.
• LLM Prediction Accuracy for Continuous ICF Profiles — Within 3 months after the completion of clinical data collection.
  Prediction accuracy of the best-performing LLM (identified in WP2) in estimating continuous clinical scores (e.g., Grip Strength, QuickDASH scores) from core clinical predictors. Accuracy will be measured using the Intraclass Correlation Coefficient (ICC) to evaluate the agreement between LLM-predicted values and actual clinical assessment results.
• LLM Prediction Accuracy for Categorical ICF Profiles — Within 3 months after the completion of clinical data collection.
  Prediction accuracy of the best-performing LLM in estimating categorical patient profiles (e.g., Eaton-Littler Stage, POAM-P activity patterns). Accuracy will be measured using Cohen's Kappa coefficient to evaluate the agreement between LLM-predicted categories and actual expert-diagnosed categories.

Trial sites (1)

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