Platelet-rich Plasma, Glucocorticoid, Saline Injection in the Treatment of Lateral Epicondylitis. Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- CHANGE İN VAS: Visual Analog Skala
研究概览
简要总结
The aim of the study is to compare the effectiveness of injection techniques in the treatment of elbow lateral epicondylitis. The functional and pain levels of the patients will be evaluated with scores such as DASH, VAS, PRTEE. At the same time, USG imaging will be evaluated before injection and in the third month after injection. The study was planned as a randomized controlled prospective study.
详细描述
Patients diagnosed with epicondylitis in our outpatient clinic will be divided into 3 groups, and patients who will receive saline in 1 group and betamethasone sodium in a group will be selected in accordance with the specified conditions and their treatment will be started, and the treatment will be started, which patient will receive which treatment will be determined by the computerized randomization program. ), 1ml prp (plate-rich plasma to be prepared with the blood taken from the patient on the day of injection), 1 ml saline (0.9 NACI), while the patient is in the supine position, the affected elbow is 90 flexion and neutral rotation, The non-dominant thumb will be placed at the sensitive point in the lateral epicondyle. The injection will be applied to the point with a 23 g needle. After the injection, the subjects will be taught a stretching exercise of the joint extensors of the wrist and fingers. Subjects will be asked to do this exercise five times in one session, two sessions a day.Examination and functional scores to be applied to the patients during follow-up: VAS, DASH and PRTEE scores will be checked in the 1st 6th week, 3rd month, 6th month and 12th month VAS: Visual Analog Scale DASH: The Disabilities of the Arm, Shoulder and Hand PRTEE: The Patient-Rated Tennis Elbow Evaluation 2. It will be evaluated by USG in the 3rd month.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 18
- •Clinical diagnosis-
- •Symptoms lasting more than 3 months and no injection within this period
- •Radiologically diagnosed -
排除标准
- •symptoms for less than 3 months
- •Having been given injection treatment within 3 months
- •Surgical procedure for lateral epicondylitis
- •Having pain caused by the cervical spine
- •Restricted elbow range of motion 6.Having an elbow bony deformity
研究组 & 干预措施
saline injection
2ml %0.9 NACI(Saline )injection to effected lateral epicondyle
干预措施: plate-rich plasma (Drug)
platet riched plasma injection
2 ml prp )injection to effected lateral epicondyle
干预措施: saline (0.9 NACI) (Drug)
betametazon injection
2 ml betametazon )injection to effected lateral epicondyle
干预措施: betametazon (Drug)
结局指标
主要结局
CHANGE İN VAS: Visual Analog Skala
时间窗: baseline and 6th week, 3rd month, 6th month and 12th month
we ask questions for vas score ıt has explained https://www.orthopaedicscore.com/, minum score 1 maximum 10 The higher the score, the greater the pain, and we expect it to decrease after the process.
CHANGE İN DASH: The Disabilities of the Arm, Shoulder and Hand
时间窗: baseline and 6th week, 3rd month, 6th month and 12th month
we ask questions which has explained in https://www.orthopaedicscore.com/ The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)-this is called the DASH score. we expect it to decrease after the process.
CHANGE İN PRTEE: The Patient-Rated Tennis Elbow Evaluation
时间窗: baseline and 6th week, 3rd month, 6th month and 12th month
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is designed to evaluate pain and disability in subjects with lateral elbow tendinopathy. This questionnaire is available in Swedish, Italian, and some other languages. A Persian language version of the questionnaire is needed for both research and clinical purposes. The higher the score, the greater the pain, and we expect it to decrease after the process.
次要结局
- evaluation common extensor morphology and vascularity with ultrasound(baseline and 3 months after enjection)
研究者
Ahmet Serhat Aydın
asistant doctor
Istanbul University
