An interventional study of Physical Therapy and Physical Therapy + Sleep Guidance in Rotator Cuff Syndrome, Rotator Cuff Injury and Sleep Disorder (Disorder), sponsored by Federal University of São Paulo. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment
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
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.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's planned enrollment of 64 is close to the median of 60 across 456 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Federal University of São Paulo is the lead sponsor of 439 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Physical Therapy
Participants receive a 5-week standard physical therapy protocol (10 sessions, twice weekly) consisting of manual therapy and progressive exercises, plus structured education and guidance on sleeping positions and pillow use to optimize sleep quality.
Procedure: Physical Therapy · Behavioral: Physical Therapy + Sleep Guidance
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.
Participants receive structured education and guidance on sleeping positions and pillow use to optimize sleep quality.
Change in sleep quality between the Physical Therapy Group and the Physical Therapy + Sleeping Posture Guidance Group
Change in Sleep Quality Score as Measured by the Pittsburgh Sleep Quality Index (PSQI) Description: The PSQI is a self-reported questionnaire that assesses sleep quality over a one-month interval. It consists of 19 individual items, creating seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Scoring: The global score ranges from 0 to 21, where lower scores indicate better sleep quality. A global PSQI score greater than 5 is considered an indicator of relevant sleep disturbances.
Time frame: Time Points: Baseline (Week 1), Post-intervention (Week 5), and Follow-up (Week 12)
To compare the change in sleep quality between the Physical Therapy Group and the Physical Therapy + Sleeping Posture Guidance Group
Change in Sleep Quality Score as Measured by the Pittsburgh Sleep Quality Index (PSQI) Description: The PSQI is a self-reported questionnaire that assesses sleep quality over a one-month interval. It consists of 19 individual items, creating seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Scoring: The global score ranges from 0 to 21, where lower scores indicate better sleep quality. A global PSQI score greater than 5 is considered an indicator of relevant sleep disturbances.
Time frame: Time Points: Baseline (Week 1), Post-intervention (Week 5), and Follow-up (Week 12).
Change in Shoulder Function as Measured by the American Shoulder and Elbow Surgeons (ASES) Score
The ASES is a standardized assessment form used to evaluate shoulder function and pain. It consists of two sections: a patient self-evaluation and a clinical assessment. The patient section focuses on pain (measured by a Visual Analog Scale) and 10 items related to activities of daily living (e.g., dressing, grooming, and lifting objects). Scoring: The total score is converted to a 100-point scale, where 100 represents a normal, pain-free shoulder and 0 indicates severe disability and pain.
Time frame: Baseline (Week 1), Post-intervention (Week 5), and Follow-up (Week 12).
Change in Pain Intensity as Measured by the Visual Analog Scale (VAS)
The VAS (Escala Visual Analógica - EVA) is a unidimensional measure of pain intensity. It consists of a 10-centimeter line where the left end represents "no pain" (0) and the right end represents "the worst imaginable pain" (10). Patients are asked to mark the point on the line that best represents their current pain level. Scoring: The score is determined by measuring the distance (in centimeters or millimeters) from the "no pain" end to the patient's mark.
Time frame: Baseline (Week 1), Post-intervention (Week 5), and Follow-up (Week 12)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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