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Pre-Visit AI Symptom-Checking and Shared Decision-Making in Spine Physical Therapy

24 июля 2026 г. обновлено: Mariam ibrahim, Assiut University

When AI Is the First Clinician: Impact of Pre-Visit AI Use on Presentation, Diagnostic Expectations, and Shared Decision-Making in Spine Physical Therapy

Artificial intelligence (AI) symptom-checking tools, including large language models such as ChatGPT, are increasingly used by patients before they seek care. These tools may shape patients' beliefs about their diagnosis, how serious they think their condition is, and when they decide to seek treatment. It is not yet known how this pre-visit AI use affects the initial physical therapy encounter for spine-related problems.

This prospective observational cohort study examines whether prior use of AI symptom-checking tools influences the first physical therapy evaluation in adults presenting with spine-related musculoskeletal complaints (neck, thoracic, or low back pain, with or without radicular symptoms). Consecutive patients attending an outpatient physical therapy clinic for a new evaluation are grouped as AI users or non-AI users based on whether they used such a tool for their current complaint in the previous 30 days.

The primary outcome is shared decision-making, measured with the SDM-Q-9 immediately after the initial evaluation. Secondary outcomes include stage of presentation, agreement between the patient's expected diagnosis and the clinician's classification, baseline pain and disability, functional performance, and clinical outcomes at 2 and 6 weeks. The investigators hypothesize that prior AI use is associated with differences in shared decision-making and in how patients present for care.

Обзор исследования

Статус

Рекрутинг

Вмешательство/лечение

Подробное описание

Background and Rationale AI-based symptom-checking tools, including large language models, are increasingly used by patients as a first point of clinical interpretation before seeking care. Available evidence suggests these tools show moderate and variable diagnostic accuracy and can influence patients' diagnostic beliefs, perceived symptom severity, and healthcare-seeking behavior, raising concerns about pre-diagnostic anchoring. In spine and musculoskeletal care, early presentation, accurate classification, and patient engagement are important determinants of outcomes, and current practice relies on history, physical examination, and shared decision-making under the assumption that patients present without strongly preformed diagnostic expectations. The growing use of AI may alter this dynamic. Evidence on the real-world impact of pre-visit AI use on the physical therapy encounter is currently limited.

Objective The primary objective is to determine whether prior use of AI symptom-checking tools influences shared decision-making during the initial physical therapy evaluation in patients presenting with spine-related musculoskeletal conditions. Secondary objectives examine associations between prior AI use and stage of presentation, agreement between patient-expected and clinician diagnosis, baseline clinical status, functional performance, health-seeking behavior, and short-term clinical outcomes.

Design and Setting This is a prospective observational cohort study conducted in outpatient physical therapy clinics. No study-specific interventions are introduced; all participants receive standard physical therapy care determined by their treating clinician.

Participants and Grouping Consecutive adults (≥18 years) presenting for a new evaluation for a spine-related musculoskeletal complaint (neck, thoracic, or low back pain, with or without radicular symptoms) who can provide informed consent and complete study questionnaires in English are eligible. Patients are excluded for recent spinal surgery within the past 3 months, serious spinal pathology under active medical management (e.g., malignancy, spinal infection, acute fracture), cognitive impairment limiting consent or reliable completion of measures, or current enrollment in another study that may influence clinical decision-making or spine-related outcomes. Participants are classified into two groups based on whether they used an AI symptom-checking tool for their current complaint within the prior 30 days: AI users and non-AI users.

Study Instruments and Measures AI exposure is captured at baseline via a questionnaire assessing AI use (yes/no), tool type, frequency, degree of personalization, and reported influence on care-seeking. Clinical measures include symptom duration, pain intensity (Numeric Pain Rating Scale, 0-10), region-specific disability (Oswestry Disability Index for low back pain or Neck Disability Index for neck pain), and the Five Times Sit-to-Stand test. Diagnostic expectation is assessed by comparing the patient-expected diagnosis with the clinician's classification, categorized as match, partial match, or mismatch. Shared decision-making is measured with the SDM-Q-9 (score range 0-45; higher scores indicate greater patient involvement) immediately after the initial evaluation. Follow-up outcomes at 2 and 6 weeks include pain, disability (ODI/NDI), Global Rating of Change, self-reported adherence, and healthcare utilization.

Procedures At baseline (pre-visit), AI exposure, symptom duration, pain, and disability are collected. During the initial evaluation, the clinician performs a standard physical therapy assessment and classification, and patient expectations are recorded. Immediately post-visit, participants complete the SDM-Q-9. At 2-week and 6-week follow-up, clinical outcomes and adherence are assessed and AI use is re-evaluated. Data are recorded on standardized forms and stored securely using coded identifiers.

Sample Size The primary outcome is SDM-Q-9 following the initial evaluation. Using G*Power (v3.1.9.7), a sample of 128 participants (64 per group) provides 80% power to detect a moderate between-group difference (Cohen's d = 0.5) at a two-sided alpha of 0.05. To account for potential group imbalance and an anticipated attrition of 15-20%, approximately 200 consecutive patients will be recruited.

Statistical Analysis Continuous variables are summarized as mean ± standard deviation and categorical variables as frequencies and percentages. AI users and non-AI users are compared using independent-samples t-tests for continuous variables and chi-square tests for categorical variables. Statistical significance is set at p ≤ 0.05.

Тип исследования

Наблюдательный

Регистрация (Оцененный)

200

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Mariam A Ibrahim Principal investigator
  • Номер телефона: +20 10 01539399
  • Электронная почта: Mariam.A.ibrahim@med.aun.edu.eg

Места учебы

      • Asyut, Египет
        • Рекрутинг
        • Faculty of Medicine, Assiut University, Egypt
        • Контакт:

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Метод выборки

Невероятностная выборка

Исследуемая популяция

Adults aged 18 years or older presenting for a new evaluation at outpatient physical therapy clinics for a spine-related musculoskeletal complaint - neck, thoracic, or low back pain, with or without radicular symptoms. Consecutive eligible patients are enrolled and grouped by their use of AI-based symptom-checking tools for the current complaint in the 30 days preceding the visit (AI users vs. non-AI users). Patients with recent spinal surgery, serious spinal pathology under active management, cognitive impairment limiting participation, or concurrent enrollment in a study affecting spine-related decision-making are not included.

Описание

Inclusion Criteria:

  • Age: 18 years or older
  • Presenting for a new evaluation at an outpatient physical therapy clinic for a spine-related musculoskeletal complaint, including Neck, Thoracic, and Low back pain With or without radicular symptoms
  • Able to provide informed consent.
  • Able to read, understand, and complete study questionnaires

Exclusion Criteria:

  • Recent spinal surgery within the past 3 months, due to differing clinical pathways and management strategies.
  • Presence of serious spinal pathology under active medical management, such as:

Malignancy (e.g., metastatic disease) Spinal infection Acute fracture

  • Cognitive impairment or other conditions that limit the ability to provide informed consent or reliably complete study measures.
  • Patients currently enrolled in another study that may influence clinical decision-making or outcomes related to spine care.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
AI Users
Patients who reported using an AI-based symptom-checking tool (e.g., a large language model such as ChatGPT) for their current spine-related complaint within the 30 days before their initial physical therapy evaluation.
Self-reported use of an AI-based symptom-checking tool (e.g., a large language model such as ChatGPT) for the current spine-related complaint during the 30 days before the initial physical therapy evaluation. This exposure occurs naturally prior to presentation and is not assigned by the investigator. Exposure status is ascertained at baseline via a questionnaire capturing whether AI was used (yes/no), the type of tool, frequency of use, degree of personalization, and the reported influence of AI use on care-seeking timing.
Non-AI Users
Patients who reported no use of any AI-based symptom-checking tool for their current spine-related complaint within the 30 days before their initial physical therapy evaluation.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Shared Decision-Making (SDM-Q-9)
Временное ограничение: Immediately after the initial physical therapy evaluation (Day 0)
Patient-perceived involvement in shared decision-making during the initial physical therapy evaluation, measured with the 9-item Shared Decision-Making Questionnaire (SDM-Q-9). Raw total score ranges from 0 to 45; higher scores indicate greater perceived patient involvement in decision-making.
Immediately after the initial physical therapy evaluation (Day 0)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Stage of Presentation (Symptom Duration)
Временное ограничение: At initial evaluation (Day 0)
Self-reported duration of the current spine-related symptoms, in days, recorded at the initial evaluation as an indicator of timeliness/stage of presentation.
At initial evaluation (Day 0)
Diagnostic Agreement (Patient-Clinician Concordance)
Временное ограничение: At initial evaluation (Day 0)
Concordance between the patient's expected diagnosis and the clinician's classification, categorized as 0 = match, 1 = partial match, 2 = mismatch.
At initial evaluation (Day 0)
Pain Intensity (Numeric Pain Rating Scale)
Временное ограничение: Day 0, 2 weeks, 6 weeks
Self-reported pain intensity on the 11-point Numeric Pain Rating Scale (0 = no pain, 10 = worst imaginable pain); higher scores indicate greater pain.
Day 0, 2 weeks, 6 weeks
Disability (ODI or NDI)
Временное ограничение: Day 0, 2 weeks, 6 weeks
Region-specific self-reported disability, using the Oswestry Disability Index for low back pain or the Neck Disability Index for neck pain. Both are scored 0-100% (0 = no disability; higher scores indicate greater disability).
Day 0, 2 weeks, 6 weeks
Health-Seeking Behavior (AI Influence on Care Timing)
Временное ограничение: At initial evaluation (Day 0)
Self-reported influence of prior AI symptom-checker use on the timing of seeking care, categorized as earlier, delayed, or no change.
At initial evaluation (Day 0)
Adherence and Healthcare Utilization
Временное ограничение: 2 weeks, 6 weeks
Self-reported adherence to the recommended treatment plan.
2 weeks, 6 weeks

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

10 июня 2026 г.

Первичное завершение (Оцененный)

10 декабря 2026 г.

Завершение исследования (Оцененный)

10 февраля 2027 г.

Даты регистрации исследования

Первый отправленный

24 июля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

24 июля 2026 г.

Первый опубликованный (Действительный)

29 июля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

29 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

24 июля 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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