Clinical Study On Extracorporeal Shock Wave Therapy For Rotator Cuff Injuries
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change from Baseline Isokinetic muscle strength testing at 4 weeks
研究概览
简要总结
This clinical trial aims to learn about the effect of extracorporeal shock wave therapy on rotator cuff injuries. The main question it aims to answer is the efficacy of extracorporeal shock wave therapy on the improvement of pain, shoulder function, and quality of life in patients with rotator cuff injuries. The experimental group of patients received extracorporeal shock wave therapy combined with conventional rehabilitation therapy. The control group only received conventional rehabilitation therapy. Compare the two groups to explore the therapeutic effect of extracorporeal shock wave therapy on rotator cuff injuries.
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)
盲法说明
assessor was blinded. The assessor, who not participated in the study, was experienced, and well qualified in the use.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria of rotator cuff injuries in 2019 American Academy of Orthopaedic Surgeons Clinical Practice Guideline for rotator Cuff Injuries (diagnostic criteria: （1）The clinical signs included positive empty cup test and full cup test, positive internal rotation resistance test in abduction and external rotation position and positive Jobe sign in lateral position. (2) Imaging: magnetic resonance imaging, magnetic resonance arthrography or ultrasound showed rotator cuff injuries, including supraspinatus, infraspinatus, teres minor and subscapularis tendon injuries);
- •Definite imaging diagnosis: magnetic resonance imaging, magnetic resonance arthrography or ultrasound examination;
- •The shoulder joint did not receive surgical treatment;
- •Both sexes, aged 20-80 years old;
- •Stable vital signs, good communication, and active cooperation to complete the relevant evaluation and treatment;
- •Informed consent was obtained from patients or their families before treatment.
排除标准
- •MRI showed medium, large and huge full-thickness rotator cuff tears;
- •Skin damage or skin disease at the application site;
- •Previous history of shoulder surgery;
- •Pregnant or lactating women;
- •Allergic constitution;
- •Patients with primary diseases of the heart, liver, kidney, or hematopoietic system, patients with mental disorders, patients with built-in cardiac pacemaker, and patients with implanted metal medical devices;
- •complicated with other diseases that cause body pain;
- •Unable to cooperate with the completion of the whole treatment and follow-up.
研究组 & 干预措施
extracorporeal shock wave therapy group
The experimental group received extracorporeal shock wave therapy combined with conventional rehabilitation therapy. Conventional rehabilitation therapy includes medium frequency electricity, ultrasound, ultrashort wave, laser, wax therapy, etc.
干预措施: Extracorporeal shock wave therapy (Device)
control group
The control group received conventional rehabilitation therapy. Conventional rehabilitation therapy includes medium frequency electricity, ultrasound, ultrashort wave, laser, wax therapy, etc.
干预措施: conventional rehabilitation therapy (Other)
结局指标
主要结局
Change from Baseline Isokinetic muscle strength testing at 4 weeks
时间窗: baseline and 4 weeks
Isokinetic muscle testing can be used for quantitative measurement of muscle strength, and the evaluation results have objectivity, accuracy, repeatability, and high sensitivity.
Change from Baseline Visual Analogue Scale at 4 weeks
时间窗: baseline and 4 weeks
Visual analogue Scale is the most commonly used single-dimensional measurement of pain intensity. The scale mainly consists of a 10-cm straight line, one end of which indicates "no pain at all" and the other end indicates "the most severe pain imaginable" or "pain to the extreme" etc. The patient will be asked to mark the corresponding position on this line to represent the intensity of the pain they feel at that time.
Change from Baseline Constant-Murley Score at 4 weeks
时间窗: baseline and 4 weeks
Constant-Murley Score is the unified shoulder score of the European Society for Shoulder and Elbow Surgery. The left and right shoulder joints were scored separately. It mainly includes 8 aspects of shoulder joint-related problems: 1, pain; 2. Degree of influence on daily life; 3. The hand can lift the height that can be reached; 4. Upper limb abduction muscle strength; 5. The degree of upper limb forward lifting; 6, the degree of upper limb abduction; 7. The degree of external rotation of the upper limbs; 8, the degree of internal rotation of the upper limb can be achieved.
Change from Baseline Range of Motion at 4 weeks
时间窗: baseline and 4 weeks
The range of motion of the shoulder joint refers to the active and passive range of motion of the shoulder joint measured with a protractor, including forward flexion, back extension, abduction, internal rotation, and external rotation.
Change from Baseline Magnetic resonance imaging at 4 weeks
时间窗: baseline and 4 weeks
Magnetic resonance imaging has good soft tissue resolution and can clearly show the injuries of tendons and ligaments around the shoulder joint. It is one of the main examination methods for the evaluation of rotator cuff injuries.
Change from Baseline Musculoskeletal ultrasound at 4 weeks
时间窗: baseline and 4 weeks
Musculoskeletal ultrasound uses high-frequency ultrasound to diagnose musculoskeletal diseases, which can clearly show the superficial soft tissue structures such as muscles, tendons, ligaments, peripheral nerves, and their lesions. It is one of the main examination methods for the evaluation of rotator cuff injuries.
次要结局
- Change from Baseline Shoulder Pain and Disability Index at 4 weeks(baseline and 4 weeks)
- Change from Baseline Disability of the Arm, Shoulder and Hand Score at 4 weeks(baseline and 4 weeks)
- Change from Baseline University of California at Los Angeles Shoulder Scale at 4 weeks(baseline and 4 weeks)
- Change from Baseline American Shoulder and Elbow Surgeons Score at 4 weeks(baseline and 4 weeks)
- Change from Baseline Pittsburgh sleep quality index at 4 weeks(baseline and 4 weeks)
研究者
Yong Liu, MD
chief physcician
The First Affiliated Hospital of Dalian Medical University