Why do Asymptomatic Rotator Cuff Tears Become Painful? Effect of Biomechanical, Psychosocial and Painrelated Factors.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Pressure Pain Thresholds (PPT)
研究概览
简要总结
In this prospective study, subjects older than 55 years with a degenerative asymptomatic rotator cuff tears will be followed for a period of 2 years. After testing, a symptom registration form will be filled in every 3 months. The test moment consists of pain measurements (pain pressure thresholds and conditioned pain modulation), biomechanical measurements (strength (including hand grip strength), range of motion, ultrasound (while measuring electromyographic activity) and shear wave elastography) and psychosocial measurements (psychosocial questionnaires).
详细描述
In this prospective study, the aim is to determine the risk factors for developing a symptomatic rotator cuff (RC) tear. It is still unknown why some patients with a RC tear develop complaints and others do not. Better understanding of the etiological factors that underlie RC pathology will increase the efficacy of early clinical intervention. A prospective study with a minimum of 2 year follow-up will be conducted. Biomechanical, psychosocial and painrelated factors will be screened as possible risk factors. We hypothesize that negative psychosocial factors and biomechanical impairments will be risk factors for an asymptomatic tear to become symptomatic over time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •55+ years old
- •male or female
- •asymptomatic rotator cuff tear diagnosed with ultrasound by a medical doctor
- •mean visual analogue score (VAS) of < 3 during daily life activities
- •no shoulder complaints having a significant influence on daily life activities
排除标准
- •recent shoulder trauma
- •massive rotator cuff tears
- •small partial thickness tears
- •neck complaints
- •history of shoulder surgery
- •history of proximal upper arm fracture
- •frozen shoulder
- •inflammatory arthritis
- •peripheral or central disorders
- •cognitive disorders
结局指标
主要结局
Pressure Pain Thresholds (PPT)
时间窗: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
PPTs will be measured on three local locations around the shoulder (supraspinatus, infraspinatus and posterior deltoid). Additionally, two more distal PPTs will be measured (erector spinae and triceps surae).
Acromiohumeral distance (AHD)
时间窗: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
The AHD is the shortest linear distance between the inferior edge of the acromion and the superior edge of the humeral head. This will be measured during rest and during muscle activity.
次要结局
- Clinical tests - mobility(Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic)
- Conditioned Pain Modulation (CPM)(Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic)
- Central Sensitization Inventory (CSI)(Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic)
- Clinical test - strength(Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic)
- Tampa Scale for Kinesiophobia (TSK)(Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic)
- Short Form-36 (SF-36)(Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic)
- Shoulder Pain and Disability Index (SPADI)(Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic)
- Depression, anxiety and stress scale (DASS-21)(Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic)
- International Physical Activity Questionnaire (IPAQ)(Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic)
- Insomnia Severity Index (ISI)(Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic)
- General Self-Efficacy Scale (GSES)(Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic)
- Shear Wave Elastography (SWE)(Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic)
- Supraspinatus muscle thickness(Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic)
- Humeral glenoid distance (HGD)(Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic)
- Electromyographic activity (EMG)(Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic)