NCT07376811

Effect Of Sleeping Posture Guidance On Sleep Quality In Patients With Rotator Cuff Syndrome

Effect Of Sleeping Posture Guidance On Sleep Quality In Patients With Rotator Cuff Syndrome Undergoing Physical Therapy: A Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study investigates sleep quality in patients with Rotator Cuff Syndrome (RCS) undergoing physical therapy treatment. Existing literature presents a gap regarding longitudinal studies evaluating the impact of physical therapy and different sleeping positions on sleep quality within this specific population. The central hypothesis is that physical therapy, combined with guidance on the best sleeping positions, reduces pain, improves shoulder function, and consequently promotes an improvement in sleep quality for RCS patients over time. The justification for this research lies in the need to better understand the relationship between physical therapy and sleep quality in RCS patients, aiming for the development of more effective and less invasive interventions. Previous studies have demonstrated that chronic pain, a common symptom of RCS, is intrinsically linked to sleep disturbances, which can lead to deleterious effects such as dopamine reduction, alterations in the descending pain modulation system, and central sensitization. Improvements in sleep quality have been observed after surgical procedures such as shoulder arthroscopy and arthroplasty, often associated with improved function and pain reduction. Thus, this study seeks to longitudinally evaluate whether physical therapy is capable of promoting a sustained improvement in sleep quality for patients with RCS

Detailed description

Background and Rationale Rotator Cuff Syndrome (RCS) is a prevalent musculoskeletal condition characterized by pain and functional limitation, which significantly impacts patients' quality of life. While physical therapy is a standard conservative treatment for reducing pain and restoring shoulder function, its longitudinal effect on sleep quality remains under-researched. Chronic pain in RCS is intrinsically linked to sleep disturbances, potentially leading to central sensitization and alterations in the pain modulation system. This study aims to address the gap in literature regarding the added benefit of structured sleep posture guidance when combined with standard rehabilitation. Study Design and Procedures This is a parallel-group, randomized controlled clinical trial with a 1:1 allocation ratio. The study is designed as a simple-blind trial, where the outcome assessors will be blinded to the participants' group assignments. Participants will be recruited from a specialized orthopedic and physical therapy center. Following the initial assessment (T0), eligible participants will be randomly assigned to either the Control Group or the Intervention Group using a set of sealed, opaque envelopes generated by an independent researcher. Intervention Protocols Control Group (Standard Physical Therapy): Participants will undergo a standardized physical therapy protocol consisting of 10 sessions (twice weekly for 5 weeks). The sessions follow evidence-based clinical practice guidelines for RCS and include: Education on ergonomics and modifications of activities of daily living. Articular mobilization and manual therapy techniques. Progressive resisted exercises, including both isometric and isotonic modalities, focused on analgesia and functional recovery. Intervention Group (Physical Therapy + Sleep Posture Guidance): Participants in this group will receive the exact same 10-session physical therapy protocol as the Control Group. Additionally, they will receive structured and personalized sleep posture guidance during the first week, with monthly reinforcements. This additional intervention includes: Specific instructions on ideal sleeping positions to minimize nocturnal shoulder stress (e.g., avoiding sleeping on the affected shoulder). Practical guidance on the use of supportive pillows to maintain the shoulder in a neutral and comfortable position throughout the night. Follow-up and Data Management The total duration of the active treatment phase is 5 weeks. Data collection occurs at three specific time points: baseline (Week 1), post-intervention (Week 5), and a late follow-up (Week 12). Assessments at Week 1 and Week 5 are conducted in person, while the Week 12 follow-up is conducted remotely via an online platform. Data will be stored and managed using secure digital platforms to ensure participant confidentiality and data integrity. Statistical Plan Overview The sample size of 64 participants was calculated to detect significant changes in sleep quality based on established PSQI score variances from similar populations. Statistical analysis will utilize both descriptive and inferential methods, applying a significance level of p ≤ 0.05 with a 95% confidence interval. Univariate and bivariate analyses will be performed to examine the relationships between pain levels, shoulder function, and sleep quality over time.

Conditions

• Rotator Cuff Syndrome
• Rotator Cuff Injury
• Sleep Disorder (Disorder)

Interventions

Type	Name	Description
PROCEDURE	Physical Therapy	This intervention is applied to all study participants (both groups). Participants receive the same 5-week standard physical therapy protocol (10 sessions, twice weekly) including manual therapy and progressive exercises, following evidence-based clinical practice guidelines for Rotator Cuff Syndrome.
BEHAVIORAL	Physical Therapy + Sleep Guidance	Participants receive structured education and guidance on sleeping positions and pillow use to optimize sleep quality.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-09-01
• Completion: 2029-11-01
• First posted: 2026-01-29
• Last updated: 2026-01-29

Locations

1 site across 1 country: Brazil