Pre-Visit AI Symptom-Checking and Shared Decision-Making in Spine Physical Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Recent spinal surgery within the past 3 months, due to differing clinical pathways and management strategies.
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
re-visit AI symptom-checker use
Other interventionSelf-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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: AI Users1 intervention
Group B: Non-AI Users0 interventions
Trial outcomes
Primary outcomes
1
Shared Decision-Making (SDM-Q-9)
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.
Time frame
Immediately after the initial physical therapy evaluation (Day 0)Secondary outcomes
1
Stage of Presentation (Symptom Duration)
Self-reported duration of the current spine-related symptoms, in days, recorded at the initial evaluation as an indicator of timeliness/stage of presentation.
Time frame
At initial evaluation (Day 0)2
Diagnostic Agreement (Patient-Clinician Concordance)
Concordance between the patient's expected diagnosis and the clinician's classification, categorized as 0 = match, 1 = partial match, 2 = mismatch.
Time frame
At initial evaluation (Day 0)3
Pain Intensity (Numeric Pain Rating Scale)
Self-reported pain intensity on the 11-point Numeric Pain Rating Scale (0 = no pain, 10 = worst imaginable pain); higher scores indicate greater pain.
Time frame
Day 0, 2 weeks, 6 weeks4
Disability (ODI or NDI)
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).
Time frame
Day 0, 2 weeks, 6 weeksSponsors and contacts
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Source ClinicalTrials.gov