Effect Of Sleeping Posture Guidance On Sleep Quality In Patients With Rotator Cuff Syndrome Undergoing Physical Therapy: A Randomized Clinical Trial
Phase: NA
Conditions: Rotator Cuff Syndrome, Rotator Cuff Injury, Sleep Disorder (Disorder)
Sponsor: Federal University of São Paulo

COVER PAGE 
 
 
Study Title: Effect of Sleeping Posture Guidance on Sleep 
Quality in Patients with Rotator Cuff Syndrome Undergoing 
Physical Therapy: A Randomized Controlled Trial 
 
 
 
Institution: Federal University of São Paulo – Paulista Medical 
School (EPM) 
 
Principal Investigator: Paulo Santoro Belangero 
Date: 04/11/2025 
Document Type: Study Protocol and Statistical Analysis Plan 
(SAP) 
 
 
 
 
 
 
 
 
 

STUDY PROTOCOL 
 
1. Objectives 
The primary objective is to evaluate the effect of sleeping posture 
guidance combined with physical therapy on the sleep quality of 
patients diagnosed with Rotator Cuff Syndrome (RCS). Secondary 
objectives include assessing improvements in shoulder function and 
pain intensity. 
2. Study Design 
This is a single-blind, two-arm, parallel-group randomized controlled 
clinical trial. 
• Experimental Group (n=32): Standard Physical Therapy + 
Sleeping Posture Guidance. 
• Control Group (n=32): Standard Physical Therapy only. 
3. Intervention Protocol 
Both groups will undergo 10 physical therapy sessions (twice weekly 
for 5 weeks). 
• Standard Physical Therapy: Includes manual therapy 
(articular mobilization), stretching, and progressive 
strengthening exercises (isometric and isotonic). 
• Sleeping Posture Guidance (Experimental only): In the 1st 
week, patients will receive specific instructions on optimal 
sleeping positions to reduce nocturnal subacromial pressure, 
including the use of supportive pillows. Monthly reinforcements 
will be conducted. 
4. Data Collection and Follow-up 
Assessments will be conducted at three points: 
• T0 (Baseline): Week 1, before intervention. 
• T5 (Post-intervention): Week 5, immediately after 10 
sessions. 
• T12 (Follow-up): Week 12, remote assessment via online 
questionnaire. 

STATISTICAL ANALYSIS PLAN 
 
1. Sample Size Calculation 
Based on previous studies using the Pittsburgh Sleep Quality Index 
(PSQI) as the primary outcome, a sample size of 64 participants 
(32 per group) was determined to achieve a power of 80% and a 
significance level of 0.05, accounting for a 20% expected dropout 
rate. 
2. Primary and Secondary Outcomes 
• Primary Outcome: Change in sleep quality scores (PSQI and 
Mini-Sleep Questionnaire). 
• Secondary Outcomes: Change in shoulder function (ASES 
score) and pain intensity (Visual Analog Scale - VAS). 
3. Statistical Methods 
• Descriptive Analysis: Quantitative data will be expressed as 
mean and standard deviation (or median and interquartile 
range for non-normal data). Qualitative data will be expressed 
as frequencies. 
• Normality Testing: The Shapiro-Wilk test will be used to 
determine data distribution. 
• Inference: * To compare baseline characteristics between 
groups, Independent T-tests or Mann-Whitney U tests will be 
used. 
o To evaluate the effect of the intervention over time (T0, 
T5, T12) and between groups, Generalized Estimating 
Equations (GEE) or Mixed-Model ANOVA will be 
applied. 
o The level of significance is set at p ≤ 0.05 with a 95% 
Confidence Interval (CI). 
• Software: All analyses will be performed using SPSS 
(Statistical Package for the Social Sciences) or R software.