Effect Of Sleeping Posture Guidance On Sleep Quality In Patients With Rotator Cuff Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFederal University of São Paulo
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical and/or radiological diagnosis of Rotator Cuff Syndrome (RCS).
Presence of shoulder pain for at least 3 months (chronic pain).
Patients aged between 18 and 65 years.
Patients referred for conservative physical therapy treatment.
Disqualifiers
History of surgical procedures on the affected shoulder.
Presence of fractures or recent acute trauma in the shoulder or upper limb.
Associated neurological disorders, inflammatory systemic diseases (e.g., Rheumatoid Arthritis), or adhesive capsulitis (frozen shoulder).
Previous diagnosis of primary sleep disorders unrelated to pain (e.g., severe obstructive sleep apnea) already under clinical treatment.
Trial design
Design model
Parallel
Treatments tested in this trial
Physical Therapy
Procedure/SurgeryThis 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.
Physical Therapy + Sleep Guidance
BehavioralParticipants receive structured education and guidance on sleeping positions and pillow use to optimize sleep quality.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Active Comparator group (Physical Therapy)Active comparator 1 intervention
Group B: Experimental group (Physical Therapy combined with Sleeping Posture Guidance)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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)2
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).Secondary outcomes
1
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).2
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Federal University of São Paulo
Lead sponsor
Unifesp Escola Paulista de Medicina
Collaborator
Source ClinicalTrials.gov
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