NCT07148687

Brief Summary

This study aims to evaluate the effects of rehabilitation programs supported by artificial intelligence-based large language models (LLMs), specifically ChatGPT and DeepSeek, in individuals with subacromial pain syndrome (SAPS). Participants will be randomly assigned to one of three groups: standard physiotherapy, standard physiotherapy plus ChatGPT-guided exercises, and standard physiotherapy plus DeepSeek-guided exercises. Outcomes including pain, disability, quality of life, muscle strength, and joint range of motion will be assessed before and after a 6-week intervention. The results will help determine whether AI-generated exercise recommendations can enhance clinical outcomes when combined with conventional physiotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

September 25, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

August 3, 2025

Last Update Submit

February 26, 2026

Conditions

Keywords

ChatGPTDeepSeekLarge Language ModelsShoulder RehabilitationSubacromial PainArtificial Intelligence

Outcome Measures

Primary Outcomes (1)

  • Change in Disability (Shoulder Pain and Disability Index, SPADI)

    Disability related to shoulder pain will be measured.Shoulder Pain and Disability Index (0-100; higher scores indicate worse disability).

    Baseline and after 6 weeks of intervention

Secondary Outcomes (10)

  • Change in upper extremity function (Quick DASH)

    Baseline and after 6 weeks

  • Change in shoulder range of motion (ROM)

    Baseline and after 6 weeks

  • Change in Quality of Life (Short Form-12, SF-12)

    Baseline and after 6 weeks of intervention

  • Change in Pain Intensity (Numeric Pain Rating Scale, NPRS)

    Baseline and after 6 weeks of intervention

  • Change in shoulder and elbow muscle strength (K-Force)

    Baseline and after 6 weeks

  • +5 more secondary outcomes

Study Arms (3)

Standard Exercise Group

ACTIVE COMPARATOR

Participants receive standard physiotherapy combined with a conventional exercise program for subacromial pain syndrome based on evidence-based clinical guidelines. Each group included 23 participants who completed the 6-week intervention and were included in the final analysis.

Behavioral: Conventional Exercise Program

ChatGPT-Guided Exercise Group

EXPERIMENTAL

Participants receive standard physiotherapy combined with exercises generated by the ChatGPT-4o large language model. Each group included 23 participants who completed the 6-week intervention and were included in the final analysis.

Behavioral: ChatGPT-Guided Rehabilitation

DeepSeek-Guided Exercise Group

EXPERIMENTAL

Participants receive standard physiotherapy combined with exercises generated by the DeepSeek-R1 large language model. Each group included 23 participants who completed the 6-week intervention and were included in the final analysis.

Behavioral: DeepSeek-Guided Rehabilitation

Interventions

AI-generated exercise recommendations from ChatGPT-4 tailored to the patient's profile and applied under physiotherapist supervision.

ChatGPT-Guided Exercise Group

Personalized rehabilitation exercises generated by DeepSeek-R1 and implemented under physiotherapist guidance.

DeepSeek-Guided Exercise Group

Exercise protocol targeting subacromial pain syndrome, including shoulder mobility, strengthening, and posture correction exercises based on established clinical guidelines.

Standard Exercise Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between the ages of 18 and 65
  • Having been diagnosed with Subacromial Pain Syndrome (SAPS) for at least four weeks, diagnosed through clinical and physical examination
  • Actively maintaining shoulder range of motion
  • Being cognitively and physically capable of participating in an exercise program
  • Agreeing to participate voluntarily in the research process and providing written consent

You may not qualify if:

  • Presence of other shoulder pathologies such as rotator cuff tear, frozen shoulder, glenohumeral instability, or labrum tear
  • Presence of conditions included in the differential diagnosis such as cervical radiculopathy, neurological disorders, rheumatological diseases, or fibromyalgia
  • History of shoulder surgery within the last 6 months
  • Pregnancy
  • History of systemic or neuromuscular disease
  • Refusal to consent to voluntary participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University Training and Research Hospital, Physical Medicine and Rehabilitation Department

Kırşehir, Merkez, 40100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants were informed that they would receive one of several supervised exercise-based rehabilitation programmes for subacromial pain syndrome, but were not informed of their specific group assignment or the use of large language models. The physician establishing the diagnosis and the physiotherapist performing all outcome assessments are blinded to group allocation. Treating physiotherapists are aware of group assignment but are not involved in outcome assessments or data analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to three parallel groups: 1. standard physiotherapy combined with a conventional exercise program for subacromial pain syndrome based on current clinical guidelines, 2. standard physiotherapy combined with ChatGPT-guided exercises, and 3. standard physiotherapy combined with DeepSeek-guided exercises.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 3, 2025

First Posted

August 29, 2025

Study Start

September 25, 2025

Primary Completion

December 1, 2025

Study Completion

December 20, 2025

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to ethical restrictions and institutional policy. The study was not designed with external data sharing in scope.

Locations