Comparison of the Efficiency of Low Intensity Extracorporeal Shock Wave Therapy and Low Intensity Laser Therapy in Adhesive Capsulitis Treatment: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Visual analogue scale (VAS)
研究概览
简要总结
The aim of this study is to compare the effects of extracorporeal shock wave therapy(eswt) applied in addition to conventional physical therapy on pain, mobility, functional ability, sleep quality and activities of daily living in patients with adhesive capsulitis compared to low-level laser therapy and to investigate whether they are superior to the control group.
详细描述
In this study, 60 adhesive capsulitis with age range 18-65 who applied to Kırsehir Ahi Evran University Training and Research Hospital were examined.Adhesive capsulitis is also called arthrofibrosis, which involves excessive adhesion formation along the glenohumeral joint. It is a disease of unknown etiology and is classified as primary and secondary. Primary adhesive capsulitis includes cases of idiopathic origin resulting from chronic inflammation with fibroblast proliferation. Secondary adhesive capsulitis, central nervous system involvement, arm immobilized for a long time, trauma or fracture, infectious diseases, etc. Includes post-mortem situations.
Adhesive capsulitis progression is characterized by four stages, each stage presenting a distinctive clinical picture.
low-level laser therapy supports cell proliferation and tissue regeneration with its anti-inflammatory and photobiostimulation properties.The pressure waves of ESWT pass through fluids and soft tissues and exert their effects in areas of impedance change such as bones and soft tissue spaces. These waves have mechanical and cellular effects. The most important of these effects are temporary damage to the neuronal cell membrane or increased permeability. These mechanisms may facilitate neovascularization and cellular regeneration in tissues.
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 (Investigator)
盲法说明
Patients will be randomly divided into 3 groups. (They will be selected by simple random sampling using the closed envelope method.) They will be divided into Group A (Low-intensity eswt, hot pack and exercise) and Group B (low intensity laser, hot pack and exercise) Group C (hot pack and exercise).
Outcome evaluations in the study will be carried out by a researcher who is blind to group allocation.
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
- •male and female patients who have received "adhesive capsulitis" by clinical and examination
- •Patients with loss of range of motion in the capsular pattern (external rotation > abduction > internal rotation) will be included in the study.
- •Patients who consent to participate in the study according to the informed consent form will be included in the study.
排除标准
- •Upper extremity injury in the last 6 months
- •Shoulder injection in the last 6 months
- •Existing open wound in the upper extremity area
- •Prior upper extremity surgery
- •The patient has a systemic infection
- •Uncontrolled hypertension in the patient
- •Inability of the patient to cooperate
- •The patient's unwillingness to participate in the study
- •The patient has a malignancy
结局指标
主要结局
Visual analogue scale (VAS)
时间窗: 12. week
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity
CONSTANT (MURLEY) SCORE (CS)
时间窗: 12.week
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function
次要结局
- The Short Form Health Survey (SF-36)(12. week)
- Pittsburgh Sleep Quality Index(12. week)
研究者
İSMAİL CEYLAN
Head of hand therapy clinic. PhD.
Ahi Evran University Education and Research Hospital