Effect Of Sleeping Posture Guidance On Sleep Quality In Patients With Rotator Cuff Syndrome Undergoing Physical Therapy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change in sleep quality between the Physical Therapy Group and the Physical Therapy + Sleeping Posture Guidance Group
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
Active Comparator group (Physical Therapy)
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.
干预措施: Physical Therapy (Procedure)
Experimental group (Physical Therapy combined with Sleeping Posture Guidance)
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.
干预措施: Physical Therapy (Procedure)
Experimental group (Physical Therapy combined with Sleeping Posture Guidance)
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.
干预措施: Physical Therapy + Sleep Guidance (Behavioral)
结局指标
主要结局
Change in sleep quality between the Physical Therapy Group and the Physical Therapy + Sleeping Posture Guidance Group
时间窗: 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
时间窗: 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.
次要结局
- 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))
研究者
Paulo Santoro Belangero
Affiliate Professor Of The Department Of Orthopedics And Traumatology Paulista Medical School / Federal University Of São Paulo (UNIFESP) Sports Medicine And Physical Activity Division
Federal University of São Paulo