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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25-74
SponsorHacettepe University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

93 Participants
are grouped into 1 trial group
Group A: TMC OA Group

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline (single assessment at enrollment)
2

Pinch Strength

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

Time frame
Baseline (single assessment at enrollment)
3

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.

Time frame
Baseline (single assessment at enrollment)
4

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.

Time frame
Baseline (single assessment at enrollment)

Secondary outcomes

1

Correlations Between Pain-Activity Patterns and Clinical Variables

This measure evaluates the correlation between the subscale scores of the Patterns of Activity Measure-Pain (POAM-P) questionnaire (Avoidance, Overdoing, and Pacing) and clinical parameters, including pain intensity (VAS), grip strength (kg), upper extremity disability (QuickDASH), and emotional status (HADS). Correlation will be analyzed using Spearman's or Pearson's correlation coefficients depending on the data distribution. Unit of Measure: Correlation Coefficient

Time frame
Baseline (single assessment at enrollment)
2

Kinesiophobia Level (Tampa Kinesiophobia Scale)

Level of fear of movement or re-injury will be assessed using the unabbreviated 17-item Tampa Scale of Kinesiophobia (TSK-17). Total scores range from a minimum of 17 to a maximum of 68. Higher scores indicate a greater level of kinesiophobia (worse outcome).

Time frame
Baseline (single assessment at enrollment).
3

Pain Beliefs Profile (Pain Beliefs Questionnaire)

This measure assesses the patients' beliefs about the cause of their pain using the unabbreviated Pain Beliefs Questionnaire (PBQ). The PBQ consists of two subscales: Organic Beliefs and Psychological Beliefs. Each subscale score is evaluated, and their correlation with coping strategies and emotional status is analyzed. For each subscale, scores range from 1 to 6 (calculated as an average of items), where higher scores indicate a stronger belief in that specific dimension (e.g., higher organic scores mean a stronger belief that pain has a physical cause).

Time frame
Baseline (single assessment at enrollment)
4

Anxiety and Depression (Hospital Anxiety and Depression Scale)

Emotional status will be assessed using the Hospital Anxiety and Depression Scale (HADS). The scale consists of two subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D). Each subscale ranges from 0 to 21, where higher scores indicate greater levels of anxiety or depression (worse outcome).

Time frame
Baseline (single assessment at enrollment).

Other outcomes

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