Effect of ChatGPT and DeepSeek-Guided Rehabilitation on Clinical Outcomes in Individuals With Subacromial Pain Syndrome
Phase: NA
Conditions: Subacromial Pain Syndrome
Sponsor: Kirsehir Ahi Evran Universitesi

Trial title: Effect of ChatGPT and DeepSeek-Guided Rehabilitation on Clinical Outcomes in Individuals With 
Subacromial Pain Syndrome 
ClinicalTrials.gov: NCT07148687 
Version date: 24 February 2026 
Design: Triple-masked (participant-, diagnosing clinician-, and outcome assessor–blinded), 3-arm, parallel-group 
randomized controlled trial 
Setting: Outpatient Physical Medicine and Rehabilitation clinic, Kırşehir Ahi Evran University Training and 
Research Hospital (Kırşehir, Türkiye) 
Ethics and Registration 
The trial was prospectively registered at ClinicalTrials.gov (NCT07148687). Ethical approval was obtained from 
Selçuk University Faculty of Health Sciences Ethics Committee for Non-Interventional Clinical Investigations 
(Approval No: 2025/874). All participants provided written informed consent prior to enrollment. The study was 
conducted in accordance with the Declaration of Helsinki. Recruitment occurred from 25 Sep 2025 to 1 Dec 2025, 
and final follow-up assessments were completed on 20 Dec 2025. 
Participants 
Adults with shoulder pain were screened and referred when subacromial pain syndrome (SAPS) was diagnosed 
based on standardized history and physical examination consistent with rotator cuff–related shoulder pain. SAPS 
classification was supported using a test-cluster approach (painful arc, Hawkins–Kennedy, and resisted external 
rotation/infraspinatus strength test); SAPS was considered clinically supported when ≥2 tests were positive. 
Inclusion criteria: age 18–65 years; clinical SAPS ≥4 weeks; sufficient active shoulder ROM to participate; able 
to attend supervised sessions; written consent. 
Exclusion criteria: suspected/confirmed full-thickness rotator cuff tear, adhesive capsulitis, glenohumeral 
instability, 
or 
labral 
tear; 
cervical 
radiculopathy/neurological 
disorders/inflammatory 
rheumatic 
disease/fibromyalgia; shoulder surgery in past 6 months; systemic or neuromuscular disease; pregnancy; 
withdrawal/refusal of consent. 
Randomization, Allocation Concealment, and Masking 
After baseline assessment, participants were randomized (1:1:1) to: 
Conventional physiotherapy + conventional exercise program 
Conventional physiotherapy + ChatGPT-guided exercise program 
Conventional physiotherapy + DeepSeek-guided exercise program 
 
An independent administrative staff member (not involved in recruitment, treatment delivery, or outcome 
assessment) generated and implemented allocation using Randomizer.org with simple randomization. The 

allocation list was stored as an encrypted file and remained inaccessible to recruiters, treating physiotherapists, 
and outcome assessors until baseline assessments were completed. Group assignment was revealed to the treating 
physiotherapist after baseline measurements. 
Masking: Participants were informed that they would receive one of several supervised exercise-based 
rehabilitation programs for SAPS, but were not informed of their specific group assignment or the use of large 
language models. The diagnosing clinician and the outcome assessor were blinded to allocation. Treating 
physiotherapists were aware of group assignment but were not involved in outcome assessments or data analysis. 
Data management and statistical analysis were performed using coded group labels until primary analyses were 
completed. At week 6, the outcome assessor recorded a forced guess of group allocation to descriptively evaluate 
assessor blinding. 
Interventions (6 weeks; 3 sessions/week; 18 sessions) 
All participants completed supervised outpatient sessions (60 min; duration recorded). Attendance (0–18) was 
recorded. Pain response was monitored with a prespecified rule: acceptable pain during/after exercise ≤4/10 
(NPRS) without meaningful increase in night pain or next-day baseline pain; if exceeded, exercises were regressed 
(reduced load/ROM/lever arm/sets/reps, added support). 
Common physiotherapy modalities (all groups; identical co-interventions): 
Moist hot pack 20 min 
Conventional TENS 100 Hz, 60 μs; 20 min 
Therapeutic ultrasound 1 MHz, 1.5 W/cm²; 5 min 
Delivered 3 sessions/week for 6 weeks. 
Exercise programs: All programs were structured into early/middle/late phases and progressed using the same 
pain-monitoring rule and performance criteria (technique, tolerance, symptom stability). 
Conventional program: developed a priori by experienced musculoskeletal physiotherapists; mobility/active-
assisted 
elevation, 
scapular 
stabilization, 
progressive 
rotator 
cuff 
strengthening, 
upper-quadrant 
stretching/strengthening. 
LLM-guided programs: 
ChatGPT group: ChatGPT-4o (OpenAI; web interface) 
DeepSeek group: DeepSeek-R1 (DeepSeek; web interface) 
A standardized English prompt requested a 6-week (18-session) supervised outpatient, exercise-only program for 
SAPS 
with 
basic 
clinic 
equipment, 
3 
phases, 
with 
exercise-specific 
dosage, 
symptom-based 
progression/regression, and the pain-monitoring rule. The identical prompt was submitted in 3 independent 
sessions per model. A musculoskeletal physiotherapist synthesized a single master program per model, retaining 
safe/feasible items aligned with SAPS rehabilitation principles and removing potentially unsafe/disproportionate 

items (examples documented in Supplementary Table S2). Final session-by-session programs are provided in 
Supplementary Table S1; prompt text is provided in Supplementary Appendix S1. 
Outcomes and Assessment Schedule 
Outcomes were assessed at baseline (week 0) and post-intervention (week 6) by the same blinded assessor. 
Primary outcome: 
SPADI (0–100; higher = worse pain/disability) 
Key secondary outcomes: 
NPRS activity pain (0–10) 
QuickDASH (0–100) 
SF-12 Physical Component Summary (PCS) 
Exploratory outcomes: NPRS rest/night; SF-12 MCS; active shoulder ROM (goniometer); isometric strength 
(Kinvent K-Force; Newtons); TSK; ASES; PCS; HADS; WORC. Internal rotation strength was not analyzed due 
to measurement standardization concerns in the handheld dynamometry setup. 
Safety Monitoring 
Adverse events were monitored at each supervised session and at week 6 using standardized questioning and 
spontaneous reporting. No intervention-related adverse events were reported. 
Sample Size 
A priori sample size estimation (G*Power 3.1) targeted detection of a clinically meaningful difference in SPADI, 
assuming medium effect size (f=0.25), α=0.05, 80% power for a 3-group, 2-time-point repeated-measures 
framework, yielding a minimum of 54 participants (18/group). To allow for attrition and equal group sizes, the 
target was 75 participants (25/group). 
Statistical Analysis Plan (SAP) 
Analyses were conducted in IBM SPSS Statistics v25.0. Continuous variables are summarized as mean (SD) or 
median (IQR); categorical variables as n (%). Baseline comparability was assessed with 1-way ANOVA (or 
Kruskal–Wallis as appropriate) and chi-square tests. 
Primary inference: For each outcome, between-group comparisons were based on change scores (week 6 minus 
baseline). Change scores were compared across 3 groups using 1-way ANOVA; Kruskal–Wallis was used when 
assumptions were not met. If an omnibus test was significant, pairwise post hoc comparisons of change scores 
were conducted with Bonferroni adjustment. 
 

Multiplicity control: SPADI primary hypothesis tested at two-tailed α=0.05. Holm–Bonferroni adjustment was 
applied across prespecified key secondary outcomes (NPRS-activity, QuickDASH, SF-12 PCS). Exploratory 
outcomes were analyzed similarly but interpreted as hypothesis-generating without multiplicity adjustment. 
Effect sizes: η² for omnibus between-group comparisons; Hedges g (or Cohen’s d) for pairwise differences. 
Missing data: Complete-case approach (participants with both baseline and week-6 data); missing outcomes not 
imputed. Participant flow and attrition were documented; discontinuations were due to scheduling conflicts (2 per 
group). 
IPD/Data Sharing 
Individual participant data (IPD) will not be shared due to ethical restrictions and institutional policy.