Trapeziometacarpal OsteoarthritisICFNCT07458971
ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model
An observational study of Trapeziometacarpal Osteoarthritis and Thumb Osteoarthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 74 years
- Conditions the study is for
- Trapeziometacarpal Osteoarthritis, Thumb Osteoarthritis, Carpometacarpal Osteoarthritis
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Feb 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with trapeziometacarpal osteoarthritis referred to the Hand Surgery Rehabilitation Unit at Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Ankara, Turkey.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Hand Surgery Rehabilitation Unit
Ankara
Tugba Ulusoy, MSc, +90 5075097351, tugbaulusoy1@gmail.com
About this study
Official title: ICF-Based Biopsychosocial Assessment With Artificial Intelligence-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model
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:
Read more
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.
Read the detailed description
This research consists of three independent but interrelated work packages with different methods and targets.
Work Package 1 (Clinical Data Collection and ICF-Based Profile Analysis): Participants with TMC OA will undergo a single face-to-face comprehensive assessment using a cross-sectional design. The assessment battery is structured according to the ICF framework and covers five domains: (a) Body Structure/Function: pain, joint mobility, grip and pinch strength, joint stability, and OA staging; (b) Activity: daily activity limitations and pain-activity patterns (avoidance, overdoing, pacing); (c) Participation: social, domestic, and occupational participation; (d) Personal Factors: pain beliefs, coping strategies, kinesiophobia, anxiety, and depression; (e) Environmental Factors: family support and ergonomic adaptations.
Work Package 2 (Comparison of Large Language Models' Clinical Knowledge Performance): Forty patient questions derived from search-engine "People Also Ask" data are submitted programmatically, through provider application programming interfaces, to four large language models (GPT-5.2, Claude Opus 4.6, Gemini 2.5 Pro, LLaMA 4 Maverick) under two prompting conditions: zero-shot, and with a clinician-oriented system prompt. This yields 320 responses. Two experts (a hand therapist and a hand surgeon), blinded to model identity and prompting condition, independently rate each response for accuracy, comprehensiveness and clinical relevance on anchored 5-point scales. Criterion-level disagreements of two points or more are referred to a third blinded hand surgeon, whose rating is substituted for that criterion. Readability is computed automatically as Flesch Reading Ease and Flesch-Kincaid Grade Level.
Work Package 3 (LLM-Based Predictive Profile Modeling): The best-performing LLM identified in WP2 will be provided with core clinical predictors from WP1 data. The model's predictions for multidimensional ICF-based patient profiles will be compared against actual assessment results using established agreement and performance metrics.
Sample size: Based on a priori power analysis (alpha=0.05, power=0.80, effect size=0.131), a minimum of 93 participants is required.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (single assessment at enrollment)
Pinch Strength
Measured using a pinchmeter to assess tip-to-tip and key pinch strength. Unit of Measure: Kilograms
Measured: 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.
Measured: 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.
Measured: Baseline (single assessment at enrollment)
Pain Duration
Total duration of thumb pain reported by the participant.
Measured: 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).
Measured: Baseline (single assessment at enrollment)
Radial Subluxation Ratio
Radiographic measurement of the radial subluxation of the metacarpal base on the trapezium.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 3 months after the completion of clinical data collection.
Secondary outcomes (5)
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
Measured: Baseline (single assessment at enrollment)
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).
Measured: Baseline (single assessment at enrollment).
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).
Measured: Baseline (single assessment at enrollment)
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).
Measured: Baseline (single assessment at enrollment).
Pain Coping Strategies (Pain Coping Questionnaire)
Evaluation of the various methods used by participants to manage their pain using the unabbreviated Pain Coping Questionnaire (PCQ). The questionnaire assesses different subscales such as Information Seeking, Problem Solving, and Distraction. Each subscale is scored, and higher scores indicate a more frequent use of that specific coping strategy (higher scores generally represent better or more active coping, depending on the specific subscale).
Measured: Baseline (single assessment at enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start19 Feb 2026
- Primary completionOct 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trapeziometacarpal OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cigdem Ayhan, Hacettepe University
- Investigators
- Cigdem Ayhan Kuru, Professor, Study director, Hacettepe University, Faculty of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458971
- Sponsor's protocol ID
- FTREK25/168
- Acronym
- ICF
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICF-Based Biopsychosocial Assessment With Artificial Intelligence-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model
- ClinicalTrials.gov ID
- NCT07458971
- Acronym / sponsor ID
- ICF / FTREK25/168
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This research consists of three independent but interrelated work packages with different methods and targets.
Work Package 1 (Clinical Data Collection and ICF-Based Profile Analysis): Participants with TMC OA will undergo a single face-to-face comprehensive assessment using a cross-sectional design. The assessment battery is structured according to the ICF framework and covers five domains: (a) Body Structure/Function: pain, joint mobility, grip and pinch strength, joint stability, and OA staging; (b) Activity: daily activity limitations and pain-activity patterns (avoidance, overdoing, pacing); (c) Participation: social, domestic, and occupational participation; (d) Personal Factors: pain beliefs, coping strategies, kinesiophobia, anxiety, and depression; (e) Environmental Factors: family support and ergonomic adaptations.
Work Package 2 (Comparison of Large Language Models' Clinical Knowledge Performance): Forty patient questions derived from search-engine "People Also Ask" data are submitted programmatically, through provider application programming interfaces, to four large language models (GPT-5.2, Claude Opus 4.6, Gemini 2.5 Pro, LLaMA 4 Maverick) under two prompting conditions: zero-shot, and with a clinician-oriented system prompt. This yields 320 responses. Two experts (a hand therapist and a hand surgeon), blinded to model identity and prompting condition, independently rate each response for accuracy, comprehensiveness and clinical relevance on anchored 5-point scales. Criterion-level disagreements of two points or more are referred to a third blinded hand surgeon, whose rating is substituted for that criterion. Readability is computed automatically as Flesch Reading Ease and Flesch-Kincaid Grade Level.
Work Package 3 (LLM-Based Predictive Profile Modeling): The best-performing LLM identified in WP2 will be provided with core clinical predictors from WP1 data. The model's predictions for multidimensional ICF-based patient profiles will be compared against actual assessment results using established agreement and performance metrics.
Sample size: Based on a priori power analysis (alpha=0.05, power=0.80, effect size=0.131), a minimum of 93 participants is required.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 25 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with trapeziometacarpal osteoarthritis referred to the Hand Surgery Rehabilitation Unit at Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Ankara, Turkey.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Grip Strength
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Baseline (single assessment at enrollment)
Total duration of thumb pain reported by the participant.
Radiographic Severity (Eaton-Littler Stage)
Time frame: 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
Time frame: Baseline (single assessment at enrollment)
Radiographic measurement of the radial subluxation of the metacarpal base on the trapezium.
Upper Extremity Disability (QuickDASH)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Baseline (single assessment at enrollment)
Active range of motion of the thumb joints measured using a goniometer. Unit of Measure: Degrees
Provocative Tests
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
5 secondary outcomes
Correlations Between Pain-Activity Patterns and Clinical Variables
Time frame: Baseline (single assessment at enrollment)
Kinesiophobia Level (Tampa Kinesiophobia Scale)
Time frame: Baseline (single assessment at enrollment).
Pain Beliefs Profile (Pain Beliefs Questionnaire)
Time frame: Baseline (single assessment at enrollment)
Anxiety and Depression (Hospital Anxiety and Depression Scale)
Time frame: Baseline (single assessment at enrollment).
Pain Coping Strategies (Pain Coping Questionnaire)
Time frame: Baseline (single assessment at enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes. 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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Hand, Hand Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cigdem Ayhan Kuru, Professor study director
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trapeziometacarpal Osteoarthritis and Thumb Osteoarthritis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tugba Ulusoy, MSc (+90 5075097351, tugbaulusoy1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip Strength (time frame: Baseline (single assessment at enrollment)). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.