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

NCT07376811 | Not Yet Recruiting

• 1 other identifier: 93319125.3.0000.5505
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

rotator cuff syndrome; sleep quality; sleeping position; physical therapy; randomized controlled trial; shoulder pain; rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 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 Points: Baseline (Week 1), Post-intervention (Week 5), and Follow-up (Week 12).

Secondary Outcomes (2)

• Change in Shoulder Function as Measured by the American Shoulder and Elbow Surgeons (ASES) Score

  Baseline (Week 1), Post-intervention (Week 5), and Follow-up (Week 12).

• Change in Pain Intensity as Measured by the Visual Analog Scale (VAS)

  Baseline (Week 1), Post-intervention (Week 5), and Follow-up (Week 12)

Study Arms (2)

Active Comparator group (Physical Therapy)

ACTIVE COMPARATOR

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

Experimental group (Physical Therapy combined with Sleeping Posture Guidance)

EXPERIMENTAL

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

Interventions

Physical Therapy PROCEDURE

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.

Active Comparator group (Physical Therapy); Experimental group (Physical Therapy combined with Sleeping Posture Guidance)

Physical Therapy + Sleep Guidance BEHAVIORAL

Participants receive structured education and guidance on sleeping positions and pillow use to optimize sleep quality.

Experimental group (Physical Therapy combined with Sleeping Posture Guidance)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Ability to understand and answer the assessment questionnaires (PSQI, MSQ, ASES, and VAS).
• Voluntarily signing the Informed Consent Form (ICF).

You may not qualify if:

• 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.
• Recent history of corticosteroid injections in the shoulder (within the last 3 months).

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Unifesp Escola Paulista de Medicina: collaborator

Study Sites (1)

Instituto Buran

São Caetano do Sul, São Paulo, 09520070, Brazil

Location

Related Publications (5)

• Hodgetts CJ, Leboeuf-Yde C, Beynon A, Walker BF. Shoulder pain prevalence by age and within occupational groups: a systematic review. Arch Physiother. 2021 Nov 4;11(1):24. doi: 10.1186/s40945-021-00119-w.

  PMID: 34736540 RESULT

• Cofield RH. Rotator cuff disease of the shoulder. J Bone Joint Surg Am. 1985 Jul;67(6):974-9. No abstract available.

  PMID: 4019548 RESULT

• Khazzam MS, Mulligan EP, Brunette-Christiansen M, Shirley Z. Sleep Quality in Patients With Rotator Cuff Disease. J Am Acad Orthop Surg. 2018 Mar 15;26(6):215-222. doi: 10.5435/JAAOS-D-16-00547.

  PMID: 29517624 RESULT

• Finan PH, Goodin BR, Smith MT. The association of sleep and pain: an update and a path forward. J Pain. 2013 Dec;14(12):1539-52. doi: 10.1016/j.jpain.2013.08.007.

  PMID: 24290442 RESULT

• Desmeules F, Roy JS, Lafrance S, Charron M, Dube MO, Dupuis F, Beneciuk JM, Grimes J, Kim HM, Lamontagne M, McCreesh K, Shanley E, Vukobrat T, Michener LA. Rotator Cuff Tendinopathy Diagnosis, Nonsurgical Medical Care, and Rehabilitation: A Clinical Practice Guideline. J Orthop Sports Phys Ther. 2025 Apr;55(4):235-274. doi: 10.2519/jospt.2025.13182.

  PMID: 40165544 RESULT

Related Links

• Survey link for participant data collection (Portuguese)

MeSH Terms

Conditions

Rotator Cuff Injuries; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Shoulder Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Paulo S Belangero, PHD professor

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thiago C Buran

CONTACT

+5511975719815; thiburan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliate Professor Of The Department Of Orthopedics And Traumatology Paulista Medical School / Federal University Of São Paulo (UNIFESP) Sports Medicine And Physical Activity Division

Model Details: This is a two-arm, parallel-group randomized clinical trial designed to compare the efficacy of two conservative treatment approaches. Participants diagnosed with Rotator Cuff Syndrome (RCS) are randomly allocated to one of two groups: an Active Comparator group (Standard Physical Therapy) or an Experimental group (Standard Physical Therapy combined with Sleeping Posture Guidance). The study evaluates outcomes at three distinct time points: baseline (T0), immediate post-intervention at 5 weeks (T5), and a long-term follow-up at 12 weeks (T12).

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 29, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): November 1, 2029
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)