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

NCT07458971 | Not Yet Recruiting

• 1 other identifier: FTREK25/168
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trapeziometacarpal Osteoarthritis; Thumb Osteoarthritis; Carpometacarpal Osteoarthritis; Thumb Basal Joint Osteoarthritis

Keywords

ICF; Biopsychosocial Assessment; Large Language Model; Artificial Intelligence; Trapeziometacarpal Joint; Prediction Model; Clinical Decision Support; Pain-Activity Patterns

Outcome Measures

Primary Outcomes (25)

• Grip Strength

  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

  Baseline (single assessment at enrollment)

• Pinch Strength

  Measured using a pinchmeter to assess tip-to-tip and key pinch strength. Unit of Measure: Kilograms

  Baseline (single assessment at enrollment)

• Thumb Opposition (Kapandji Score)

  Assessment of thumb opposition using the Kapandji score, which ranges from 0 to 10. Higher scores indicate better thumb opposition and mobility.

  Baseline (single assessment at enrollment)

• Pain Intensity

  Measured using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.

  Baseline (single assessment at enrollment)

• Pain Duration

  Total duration of thumb pain reported by the participant.

  Baseline (single assessment at enrollment)

• Radiographic Severity (Eaton-Littler Stage)

  Evaluation of the trapeziometacarpal joint osteoarthritis stage based on the Eaton-Littler classification (Stages I through IV).

  Baseline (single assessment at enrollment)

• Radial Subluxation Ratio

  Radiographic measurement of the radial subluxation of the metacarpal base on the trapezium.

  Baseline (single assessment at enrollment)

• Upper Extremity Disability (QuickDASH)

  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.

  Baseline (single assessment at enrollment)

• Hand Disability (Turkish Thumb Disability Index - TDX)

  Assessment of thumb-related disability. Scores range from 0 to 100, with higher scores indicating greater functional impairment.

  Baseline (single assessment at enrollment)

• Joint Hypermobility (Beighton Score)

  Assessment of generalized joint laxity using the Beighton score. The total score ranges from 0 to 9, where higher scores indicate greater hypermobility.

  Baseline (single assessment at enrollment)

• Thumb Joint Range of Motion

  Active range of motion of the thumb joints measured using a goniometer. Unit of Measure: Degrees

  Baseline (single assessment at enrollment)

• Provocative Tests

  Clinical assessment using metacarpal adduction and extension tests to provoke symptoms. Presence or absence of pain (Binary: Yes/No)

  Baseline (single assessment at enrollment)

• Environmental Factors: Social Support and Ergonomic Adaptations

  Qualitative assessment of the participant's family support and the presence of ergonomic adaptations in their daily environment.

  Baseline (single assessment at enrollment)

• Emotional Status (Hospital Anxiety and Depression Scale)

  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).

  Baseline (single assessment at enrollment)

• Kinesiophobia Level (Tampa Scale of Kinesiophobia)

  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).

  Baseline (single assessment at enrollment)

• Pain-Activity Patterns (Patterns of Activity Measure-Pain).

  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.

  Baseline (single assessment at enrollment).

• Pain Beliefs Profile (Pain Beliefs Questionnaire)

  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).

  Baseline (single assessment at enrollment).

• Pain Coping Strategies (Pain Coping Questionnaire).

  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.

  Baseline (single assessment at enrollment).

• Large Language Model Clinical Knowledge Accuracy

  Performance comparison of four large language models (Claude, ChatGPT, Gemini, LLaMA) on 40 clinical questions. Evaluated by two independent blinded experts using a 4-point Likert scale (1: Completely Incorrect, 4: Completely Correct). Higher scores indicate better accuracy.

  Baseline (single assessment during the data collection period)

• Large Language Model Response Reproducibility

  Assessment of content consistency between two repeated queries of the same questions. Evaluated based on the percentage of agreement between the two sets of responses.

  Within 24 hours after initial query

• Large Language Model Content Comprehensiveness

  Evaluation of how thoroughly the model covers the necessary clinical details. Measured on a 5-point scale (1: Very Poor, 5: Very Good). Higher scores indicate more comprehensive answers.

  Baseline (single assessment at enrollment)

• Large Language Model Clinical Relevance

  Assessment of the practical utility of the responses for clinical practice. Measured on a 5-point scale (1: Not Relevant, 5: Highly Relevant). Higher scores indicate greater clinical utility.

  Baseline (single assessment)

• Large Language Model Readability Score

  The readability of the generated responses will be calculated using the Flesch Reading Ease Score. Scores typically range from 0 to 100, where higher scores indicate that the text is easier to read.

  Baseline (calculated immediately after response generation)

• LLM Prediction Accuracy for Continuous ICF Profiles

  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.

  Within 3 months after the completion of clinical data collection.

• LLM Prediction Accuracy for Categorical ICF Profiles

  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.

  Within 3 months after the completion of clinical data collection.

Secondary Outcomes (5)

• Correlations Between Pain-Activity Patterns and Clinical Variables

  Baseline (single assessment at enrollment)

• Kinesiophobia Level (Tampa Kinesiophobia Scale)

  Baseline (single assessment at enrollment).

• Pain Beliefs Profile (Pain Beliefs Questionnaire)

  Baseline (single assessment at enrollment)

• Anxiety and Depression (Hospital Anxiety and Depression Scale)

  Baseline (single assessment at enrollment).

• Pain Coping Strategies (Pain Coping Questionnaire)

  Baseline (single assessment at enrollment)

Study Arms (1)

TMC OA Group

Individuals diagnosed with trapeziometacarpal osteoarthritis (TMC OA) by an orthopedic surgeon and/or hand surgeon, with symptoms persisting for more than 3 months, aged 25-74 years, referred to the Hand Surgery Rehabilitation Unit. All participants will undergo the same ICF-based comprehensive biopsychosocial assessment battery in a single face-to-face session.

Eligibility Criteria

• Age: 25 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with trapeziometacarpal osteoarthritis referred to the Hand Surgery Rehabilitation Unit at Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Ankara, Turkey.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Hand Surgery Rehabilitation Unit

Ankara, Turkey (Türkiye)

Location

Study Officials

• Cigdem Ayhan Kuru, Professor

  Hacettepe University, Faculty of Physical Therapy and Rehabilitation

  STUDY DIRECTOR

Central Study Contacts

Tugba Ulusoy, MSc

CONTACT

+90 5075097351; tugbaulusoy1@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 9, 2026
• Study Start: February 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-02

Locations

TU (1)