NCT07733752

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Jun 2026Feb 2027

Study Start

First participant enrolled

June 10, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 24, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2027

Last Updated

July 29, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

July 24, 2026

Last Update Submit

July 24, 2026

Conditions

Keywords

Artificial intelligenceChatGPTShared decision-makingSDM-Q-9SpinePatient expectations

Outcome Measures

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.

    Immediately after the initial physical therapy evaluation (Day 0)

Secondary Outcomes (6)

  • Stage of Presentation (Symptom Duration)

    At initial evaluation (Day 0)

  • Diagnostic Agreement (Patient-Clinician Concordance)

    At initial evaluation (Day 0)

  • Pain Intensity (Numeric Pain Rating Scale)

    Day 0, 2 weeks, 6 weeks

  • Disability (ODI or NDI)

    Day 0, 2 weeks, 6 weeks

  • Health-Seeking Behavior (AI Influence on Care Timing)

    At initial evaluation (Day 0)

  • +1 more secondary outcomes

Study Arms (2)

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.

Other: re-visit AI symptom-checker use

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.

Interventions

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.

AI Users

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMales, and Females
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Assiut University, Egypt

Asyut, Egypt

RECRUITING

Related Publications (13)

  • Harvey D, White S, Reid D, Cook C. Patient perspectives of process variables in musculoskeletal care pathways. Musculoskelet Sci Pract. 2025 Apr;76:103287. doi: 10.1016/j.msksp.2025.103287. Epub 2025 Feb 14.

    PMID: 39978029BACKGROUND
  • Meyer AND, Giardina TD, Spitzmueller C, Shahid U, Scott TMT, Singh H. Patient Perspectives on the Usefulness of an Artificial Intelligence-Assisted Symptom Checker: Cross-Sectional Survey Study. J Med Internet Res. 2020 Jan 30;22(1):e14679. doi: 10.2196/14679.

    PMID: 32012052BACKGROUND
  • Kuroiwa T, Sarcon A, Ibara T, Yamada E, Yamamoto A, Tsukamoto K, Fujita K. The Potential of ChatGPT as a Self-Diagnostic Tool in Common Orthopedic Diseases: Exploratory Study. J Med Internet Res. 2023 Sep 15;25:e47621. doi: 10.2196/47621.

    PMID: 37713254BACKGROUND
  • Kumar R, Dougherty C, Sporn K, Khanna A, Ravi P, Prabhakar P, Zaman N. Intelligence Architectures and Machine Learning Applications in Contemporary Spine Care. Bioengineering (Basel). 2025 Sep 9;12(9):967. doi: 10.3390/bioengineering12090967.

    PMID: 41007212BACKGROUND
  • Bensel VA, Habeck A, Brunot MH, Becton EJ, Ray M, Brackett AL, Lisi AJ. Artificial intelligence in spine care: A scoping review of treatment applications. N Am Spine Soc J. 2025 Nov 20;25:100827. doi: 10.1016/j.xnsj.2025.100827. eCollection 2026 Mar.

    PMID: 41536317BACKGROUND
  • Muelbauer EJ, Alvi MA, Kennedy DJ, Fehlings MG. The future is now: How AI is reshaping spine care. N Am Spine Soc J. 2025 Nov 14;24:100825. doi: 10.1016/j.xnsj.2025.100825. eCollection 2025 Dec.

    PMID: 41458002BACKGROUND
  • Rossettini G, Bargeri S, Cook C, Guida S, Palese A, Rodeghiero L, Pillastrini P, Turolla A, Castellini G, Gianola S. Accuracy of ChatGPT-3.5, ChatGPT-4o, Copilot, Gemini, Claude, and Perplexity in advising on lumbosacral radicular pain against clinical practice guidelines: cross-sectional study. Front Digit Health. 2025 Jun 27;7:1574287. doi: 10.3389/fdgth.2025.1574287. eCollection 2025.

    PMID: 40657647BACKGROUND
  • Basharat A, Shah R, Wilcox N, Tur G, Tripati S, Kansal P, Gandhi N, Pokuri S, Chong G, Odonkor CA, Varhabhatla N, Chow R. ChatGPT and low back pain - Evaluating AI-driven patient education in the context of interventional pain medicine. Interv Pain Med. 2025 Sep 2;4(3):100636. doi: 10.1016/j.inpm.2025.100636. eCollection 2025 Sep.

    PMID: 40978326BACKGROUND
  • Li YH, Li N, Liu ZX, Du S, Shuai Y, Yang R, Xu L, Li X, Jiang Y, Li W. The effectiveness of artificial intelligence health education accurately linking system on self-management in non-specific lower back pain patients. Front Public Health. 2025 Sep 11;13:1630329. doi: 10.3389/fpubh.2025.1630329. eCollection 2025.

    PMID: 41018793BACKGROUND
  • Baldus SG, Wiesmann M, Habel U, Gerhards A, Hasan D, Weyland CS, Truhn D, Hasl MM, Clemens B, Nikoubashman O. Patients' views on the use of artificial intelligence in healthcare: Artificial Intelligence Survey Aachen (AISA)-a prospective survey. Insights Imaging. 2026 Jan 5;17(1):6. doi: 10.1186/s13244-025-02159-3.

    PMID: 41491377BACKGROUND
  • Alzubaidi H, Hussein A, Mc Namara K, Scholl I. Psychometric properties of the Arabic version of the 9-item Shared Decision-Making Questionnaire: the entire process from translation to validation. BMJ Open. 2019 Apr 4;9(4):e026672. doi: 10.1136/bmjopen-2018-026672.

    PMID: 30948608BACKGROUND
  • Algarni AS, Ghorbel S, Jones JG, Guermazi M. Validation of an Arabic version of the Oswestry index in Saudi Arabia. Ann Phys Rehabil Med. 2014 Dec;57(9-10):653-63. doi: 10.1016/j.rehab.2014.06.006. Epub 2014 Aug 4.

    PMID: 25262247BACKGROUND
  • Zhou M, Pan Y, Zhang Y, Song X, Zhou Y. Evaluating AI-generated patient education materials for spinal surgeries: Comparative analysis of readability and DISCERN quality across ChatGPT and deepseek models. Int J Med Inform. 2025 Jun;198:105871. doi: 10.1016/j.ijmedinf.2025.105871. Epub 2025 Mar 13.

    PMID: 40107040BACKGROUND

MeSH Terms

Conditions

Low Back PainNeck PainRadiculopathy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Mariam A Ibrahim Principal investigator

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 29, 2026

Study Start

June 10, 2026

Primary Completion (Estimated)

December 10, 2026

Study Completion (Estimated)

February 10, 2027

Last Updated

July 29, 2026

Record last verified: 2026-06

Locations