ICF
Sponsor study identifier
observational
93
1 country
1
Study Start
February 19, 2026
Actual (reported)Primary Completion
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 19, 2026
Actual (reported)February 19, 2026
Actual (reported)March 9, 2026
Actual (reported)October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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)
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.
Individuals with trapeziometacarpal osteoarthritis referred to the Hand Surgery Rehabilitation Unit at Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Ankara, Turkey.
Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Hand Surgery Rehabilitation Unit
Ankara, Turkey (Türkiye)
Cigdem Ayhan Kuru, Professor
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
First Submitted
February 19, 2026
First Posted
March 9, 2026
Study Start
February 19, 2026
Actual (reported)Primary Completion
October 2026
Estimated (date passed)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
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.
Baseline (single assessment during the data collection period)
Large Language Model Content Comprehensiveness
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.
Baseline (single assessment at enrollment)
Large Language Model Clinical Relevance
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.
Baseline (single assessment)
Large Language Model Readability Score
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.
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.
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)
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 16, 2026
Record last verified: 2026-02
De-identified study data underlying the large language model component (Work Package 2), comprising all 320 model responses, expert ratings and analysis code, will be deposited in a public repository with a DOI at the time of publication.
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Source: ClinicalTrials.gov.
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