Investigating the Impact of Metabolic Syndrome on Pain, Muscle Strength, Kinesthesia, and Functionality in Rotator Cuff Injury Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Shoulder Pain Severity (Visual Analog Scale - VAS)
研究概览
简要总结
This prospective comparative study aims to investigate the effect of Metabolic Syndrome (MetS) on the outcomes of a standardized rehabilitation program in patients with Rotator Cuff Injuries (RCI). Patients diagnosed with RCI will be divided into two groups based on the presence or absence of MetS, determined by NCEP-ATP III criteria. Both groups will receive the same 4-week physiotherapy protocol including hot pack, TENS, ultrasound, and therapeutic exercises. Pain intensity, pain threshold, muscle strength, kinesthesia, and shoulder functionality will be evaluated before and after treatment. The study hypothesizes that the presence of MetS negatively affects rehabilitation outcomes in patients with RCI by altering inflammation and tissue healing processes.
详细描述
This study aims to investigate the differences in shoulder function and rotator cuff tear outcomes between individuals with and without Metabolic Syndrome (MetS). Participants will be divided into two groups: the MetS group, which meets at least three of the NCEP-ATP III criteria for Metabolic Syndrome, and the non-MetS group, which does not have MetS.
Both groups will undergo an initial assessment, focusing on shoulder function, rotator cuff tear status, and associated factors such as age, gender, and general health conditions. The study will explore how MetS may impact the recovery and function of the shoulder in individuals with rotator cuff tears, aiming to provide insights into potential treatment and rehabilitation strategies for this population.
Data will be collected at a single time point (cross-sectional study) to evaluate baseline conditions and differences between the two groups. Statistical analyses will be performed to compare outcomes and explore potential correlations with MetS criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Inclusion Criteria for the Non-MetS Group:
- •Aged between 18-65 years
- •Willing to participate in the study
- •Unilateral Rotator Cuff Tear (RMY)
- •Inclusion Criteria for the MetS Group:
- •In addition to the above criteria, meeting at least three of the NCEP-ATP III consensus criteria for Metabolic Syndrome Stable metabolic syndrome (e.g., no significant medical changes in the last 3 months)
排除标准
- •for All Participants:
- •Inability to cooperate with the tests or presence of mental health issues
- •Presence of cervical radiculopathy symptoms
- •Presence of other orthopedic pathologies in the same shoulder (e.g., fracture, prosthesis, avascular necrosis, advanced shoulder osteoarthritis, frozen shoulder, severe scapular dyskinesia, neurological diseases, etc.)
- •Presence of function-limiting neurological, vascular, or cardiac issues
- •Local steroid injection to the shoulder within the last 3 months
- •Receipt of physiotherapy or rehabilitation within the last 3 months
- •Systemic rheumatic or inflammatory diseases
- •Surgical history due to chronic rotator cuff tear
- •Diagnosis of glenohumeral joint or acromioclavicular joint arthritis
- •Severe scapular dysfunction or significant postural abnormalities
研究组 & 干预措施
RCI with MetS
Participants with rotator cuff injury and diagnosed metabolic syndrome.
RCI without MetS
Participants with rotator cuff injury but without metabolic syndrome.
结局指标
主要结局
Change in Shoulder Pain Severity (Visual Analog Scale - VAS)
时间窗: Baseline and post-treatment (approximately 4 weeks)
Pain severity will be assessed in individuals with Myofascial Pain Syndrome (MPS) affecting the shoulder using the Visual Analog Scale (VAS). The VAS is a 10 cm horizontal line where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Participants will be asked to rate their pain both at rest and during common daily activities (e.g., lifting the arm, brushing hair, dressing, reaching). Measurements will be conducted twice: once before the treatment (baseline) and once after the intervention period to evaluate changes in pain intensity.
Change in Pain Threshold (Algometer)
时间窗: Baseline and post-treatment (approximately 4 weeks)
Pain threshold will be assessed using an algometer. The device measures the point at which pressure induces discomfort or pain. The algometer will be applied to the deltoid muscle of the affected shoulder. Participants will be asked to report when they first feel discomfort or pain, and this point will be recorded as their pain threshold. The measurement will be repeated three times for each participant, with a 30-second rest period between measurements. The average of the three measurements will be used for analysis. This will be measured before and after the treatment to observe any changes in pain threshold. Measure Type: Pain Threshold Unit of Measure: Pressure (in kilopascals, kPa)
次要结局
- Change in Muscle Strength (Digital Hand Dynamometer)(Baseline and post-treatment (approximately 4 weeks))
- Change in Kinesthetic Awareness (Joint Position Sense - JPS)(Baseline and post-treatment (approximately 4 weeks))
- Change in Shoulder Function (Quick Disabilities of the Arm, Shoulder, and Hand - Quick DASH)(Baseline and post-treatment (approximately 4 weeks))
研究者
Elif Dilara Durmaz
Principal Investigator
Istinye University