Rotator Cuff SyndromeNCT07376811
Effect Of Sleeping Posture Guidance On Sleep Quality In Patients With Rotator Cuff Syndrome
A study testing Physical Therapy and Physical Therapy + Sleep Guidance in people with Rotator Cuff Syndrome and Rotator Cuff Injury, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Syndrome, Rotator Cuff Injury, Sleep Disorder (Disorder)
- What is being tested?
- Physical Therapy and Physical Therapy + Sleep Guidance
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2026to 1 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Instituto Buran
São Caetano do Sul, São Paulo, 09520070
THIAGO COSTA BURAN, 11975719815, thiburan@hotmail.com
About this study
Official title: Effect Of Sleeping Posture Guidance On Sleep Quality In Patients With Rotator Cuff Syndrome Undergoing Physical Therapy: A Randomized Clinical 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
Read the 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.
- Being tested
- Physical Therapy, Physical Therapy + Sleep Guidance
- Keywords
- rotator cuff syndrome, sleep quality, sleeping position, physical therapy, randomized controlled trial, shoulder pain, rehabilitation
- Medical subject headings
- Rotator Cuff Injuries, Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyProcedure or surgery
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.
Physical Therapy + Sleep GuidanceBehavioural
Participants receive structured education and guidance on sleeping positions and pillow use to optimize sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Physical Therapy; Behavioral: Physical Therapy + Sleep Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: Baseline (Week 1), Post-intervention (Week 5), and Follow-up (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Unifesp Escola Paulista de Medicina
- Responsible party
- Principal investigator, Paulo Santoro Belangero, Federal University of São Paulo
- Investigators
- Paulo S Belangero, PHD professor, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376811
- Sponsor's protocol ID
- 93319125.3.0000.5505
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34736540Cofield RH. Rotator cuff disease of the shoulder. J Bone Joint Surg Am. 1985 Jul;67(6):974-9. No abstract available.
PubMed 4019548Khazzam 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.
PubMed 29517624Finan 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.
PubMed 24290442Desmeules 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.
PubMed 40165544
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Sleeping Posture Guidance On Sleep Quality In Patients With Rotator Cuff Syndrome Undergoing Physical Therapy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07376811
- Acronym / sponsor ID
- 93319125.3.0000.5505
- Keywords
- rotator cuff syndrome, sleep quality, sleeping position, physical therapy, randomized controlled trial, shoulder pain, rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Unifesp Escola Paulista de Medicina
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Active Comparator group (Physical Therapy) | Active comparator | Procedure: Physical TherapyParticipants 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. |
| Experimental group (Physical Therapy combined with Sleeping Posture Guidance) | Experimental | Procedure: Physical Therapy, Behavioral: Physical Therapy + Sleep GuidanceParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyThis 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. | Procedure or surgery | Active Comparator group (Physical Therapy), Experimental group (Physical Therapy combined with Sleeping Posture Guidance) |
| Physical Therapy + Sleep GuidanceParticipants receive structured education and guidance on sleeping positions and pillow use to optimize sleep quality. | Behavioural | Experimental group (Physical Therapy combined with Sleeping Posture Guidance) |
Primary outcome
Change in sleep quality between the Physical Therapy Group and the Physical Therapy + Sleeping Posture Guidance Group
Time frame: Time Points: Baseline (Week 1), Post-intervention (Week 5), and Follow-up (Week 12)
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.
To compare the change in sleep quality between the Physical Therapy Group and the Physical Therapy + Sleeping Posture Guidance Group
Time frame: Time Points: Baseline (Week 1), Post-intervention (Week 5), and Follow-up (Week 12).
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.
2 secondary outcomes
Change in Shoulder Function as Measured by the American Shoulder and Elbow Surgeons (ASES) Score
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)
Time frame: Baseline (Week 1), Post-intervention (Week 5), and Follow-up (Week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Results publication: PubMed 34736540Hodgetts 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.
- Results publication: PubMed 4019548Cofield RH. Rotator cuff disease of the shoulder. J Bone Joint Surg Am. 1985 Jul;67(6):974-9. No abstract available.
- Results publication: PubMed 29517624Khazzam 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.
- Results publication: PubMed 24290442Finan 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.
- Results publication: PubMed 40165544Desmeules 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.
- Survey link for participant data collection (Portuguese)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paulo S Belangero, PHD professor principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy and Physical Therapy + Sleep Guidance in people with Rotator Cuff Syndrome and Rotator Cuff Injury, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thiago C Buran (+5511975719815, thiburan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep quality between the Physical Therapy Group and the Physical Therapy + Sleeping Posture Guidance Group (time frame: Time Points: Baseline (Week 1), Post-intervention (Week 5), and Follow-up (Week 12)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07376811, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.