Blood Flow Restriction Therapy Following Acute Shoulder Injury Patients: Assessment of Efficacy in Return to Activity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (60 Degrees/Second)
研究概览
简要总结
Atrophy and weakness of the shoulder are a common problem following treatment of a number of shoulder and elbow pathologies. Even with relatively short periods of reduced activity, the magnitude of muscle loss can be quite substantial.
详细描述
Blood flow restriction (BFR) therapy is one such therapeutic tool that has received increasing attention, which involves application of a pressurized tourniquet to the injured limb during rehabilitation that limits atrophy when performing strength training with weight that otherwise would not produce enough of a contraction to prevent muscular atrophy. To date, several studies have been performed on BFR therapy, however, the effect of therapy on ligamentous and tendinous injury in the upper extremity remain unclear as most studies have focused on muscular strengthening in healthy individuals and on lower extremity injuries distal to the tourniquet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •injured patient with clinical and magnetic resonance imaging (MRI) consistent with a formal diagnosis of non-operative rotator cuff and/or biceps tendinopathy
- •no prior upper extremity ipsilateral procedures or history of deep vein thrombosis
- •those willing to be part of the study
排除标准
- •patients younger than 18 or older than 55 years of age
- •a history of revision surgery or prior ipsilateral upper extremity surgery
- •concomitant ligamentous, tendinous, or cartilage injury that would alter postoperative rehabilitation protocol
- •inability to comply with the proposed follow-up clinic visits
- •patients lacking decisional capacity
结局指标
主要结局
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (60 Degrees/Second)
时间窗: Week 6
measuring shoulder strength in injured and non-injured arms for both study groups using a Biodex testing machine - Low Score indicates low torque/strength, high score indicates high torque/strength
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (180 Degrees/Second)
时间窗: Week 6
Low Score indicates low torque/strength, high score indicates high torque/strength
Shoulder Muscle Strength Analysis: External Rotation (ER) Peak Torque Average (300 Degrees/Second)
时间窗: Week 6
Low Score indicates low torque/strength, high score indicates high torque/strength
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (60 Degrees/Second)
时间窗: Week 6
Low Score indicates low torque/strength, high score indicates high torque/strength
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (180 Degrees/Second)
时间窗: Week 6
Low Score indicates low torque/strength, high score indicates high torque/strength
Shoulder Muscle Strength Analysis: Internal Rotation (IR) Peak Torque Average (300 Degrees/Second)
时间窗: Week 6
Low Score indicates low torque/strength, high score indicates high torque/strength
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Supraspinatus
时间窗: Week 6
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Rotator Cuff Muscle Cross Sectional Area (CSA) Measurement: Infraspinatus
时间窗: Week 6
Ultrasound will be used to quantify the changes in rotator cuff muscle and distal biceps cross-sectional area before and after therapy. The same multifrequency linear probe (7.5-9.0 MHz, Elegra; Siemens Medical Solutions, Erlangen, Germany) will be used throughout the study.
Visual Analog Scale (VAS) for PAIN - Baseline Scores
时间窗: Baseline
Patients will receive questionnaires (VAS) at Baseline, Week 6, 6 and 12 months after completing rehabilitation - The VAS score can be interpreted into categories of pain or symptom intensity: 0-4 mm: No pain. 5-44 mm: Mild pain. 45-74 mm: Moderate pain. 75-100 mm: Severe pain.
Visual Analog Scale (VAS) for PAIN - Week 6 Scores
时间窗: Week 6
Patients will receive questionnaires (VAS) at Baseline, Week 6, 6 and 12 months after completing rehabilitation - The VAS score can be interpreted into categories of pain or symptom intensity: 0-4 mm: No pain. 5-44 mm: Mild pain. 45-74 mm: Moderate pain. 75-100 mm: Severe pain.
Visual Analog Scale (VAS) for PAIN - Month 6 Scores
时间窗: Month 6
Patients will receive questionnaires (VAS) at Baseline, Week 6, 6 and 12 months after completing rehabilitation - The VAS score can be interpreted into categories of pain or symptom intensity: 0-4 mm: No pain. 5-44 mm: Mild pain. 45-74 mm: Moderate pain. 75-100 mm: Severe pain.
Visual Analog Scale (VAS) for PAIN - Month 12 Scores
时间窗: Month 12
Patients will receive questionnaires (VAS) at Baseline, Week 6, 6 and 12 months after completing rehabilitation - The VAS score can be interpreted into categories of pain or symptom intensity: 0-4 mm: No pain. 5-44 mm: Mild pain. 45-74 mm: Moderate pain. 75-100 mm: Severe pain.
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Baseline Scores
时间窗: Baseline
The American Shoulder and Elbow Surgeons (ASES) shoulder score is a patient-completed assessment for shoulder function and pain, ranging from 0 to 100, with higher scores indicating better function. Scoring involves a 50-point pain component derived from a visual analog scale (VAS), and a 50-point functional component from 10 activities of daily living questions, which are then weighted and added for the final score
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Week 6 Scores
时间窗: Week 6
The American Shoulder and Elbow Surgeons (ASES) shoulder score is a patient-completed assessment for shoulder function and pain, ranging from 0 to 100, with higher scores indicating better function. Scoring involves a 50-point pain component derived from a visual analog scale (VAS), and a 50-point functional component from 10 activities of daily living questions, which are then weighted and added for the final score
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Month 6 Scores
时间窗: Month 6
The American Shoulder and Elbow Surgeons (ASES) shoulder score is a patient-completed assessment for shoulder function and pain, ranging from 0 to 100, with higher scores indicating better function. Scoring involves a 50-point pain component derived from a visual analog scale (VAS), and a 50-point functional component from 10 activities of daily living questions, which are then weighted and added for the final score
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Month 12 Scores
时间窗: Month 12
The American Shoulder and Elbow Surgeons (ASES) shoulder score is a patient-completed assessment for shoulder function and pain, ranging from 0 to 100, with higher scores indicating better function. Scoring involves a 50-point pain component derived from a visual analog scale (VAS), and a 50-point functional component from 10 activities of daily living questions, which are then weighted and added for the final score
Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Baseline Scores
时间窗: Baseline
The DASH score for patients ranges from 0 to 100, with 0 representing no disability and 100 indicating the greatest possible functional impairment of the upper extremity. Patients answer a 30-item questionnaire on a five-point scale (0-4 or 0-5 depending on the scale used), rating their ability to perform tasks and their symptoms. The sum of the raw scores is then transformed into the final 0-100 DASH score
Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Week 6 Scores
时间窗: Week 6
The DASH score for patients ranges from 0 to 100, with 0 representing no disability and 100 indicating the greatest possible functional impairment of the upper extremity. Patients answer a 30-item questionnaire on a five-point scale (0-4 or 0-5 depending on the scale used), rating their ability to perform tasks and their symptoms. The sum of the raw scores is then transformed into the final 0-100 DASH score
Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Month 6 Scores
时间窗: Month 6
The DASH score for patients ranges from 0 to 100, with 0 representing no disability and 100 indicating the greatest possible functional impairment of the upper extremity. Patients answer a 30-item questionnaire on a five-point scale (0-4 or 0-5 depending on the scale used), rating their ability to perform tasks and their symptoms. The sum of the raw scores is then transformed into the final 0-100 DASH score
Disabilities of the Arm, Shoulder, and Hand Scale (DASH) Month 12 Scores
时间窗: Month 12
The DASH score for patients ranges from 0 to 100, with 0 representing no disability and 100 indicating the greatest possible functional impairment of the upper extremity. Patients answer a 30-item questionnaire on a five-point scale (0-4 or 0-5 depending on the scale used), rating their ability to perform tasks and their symptoms. The sum of the raw scores is then transformed into the final 0-100 DASH score
GH Levels - Baseline
时间窗: Baseline
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
GH Levels - Week 3
时间窗: Week 3
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
GH Levels - Week 6
时间窗: Week 6
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IGF-1 Levels - Baseline
时间窗: Baseline
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IGF-1 Levels - Week 3
时间窗: Week 3
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IGF-1 Levels - Week 6
时间窗: Week 6
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IL-6 Levels - Baseline
时间窗: Baseline
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IL-6 Levels - Week 3
时间窗: Week 3
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
IL-6 Levels - Week 6
时间窗: Week 6
Patients will receive the blood draws in the physical therapy clinic - ELISA will be used to quantify plasma levels
次要结局
未报告次要终点