Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder: Randomized Comparative Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Shoulder Pain and Disability Index (SPADI) questionnaire
研究概览
简要总结
Aim of This study is to compare between the effect of ultrasound-guided local injection of Platelet Rich Plasma (PRP)versus Hyaluronic (HA) for the treatment of chronic shoulder pain.
详细描述
This study was prospective randomized comparative trial on patients with chronic shoulder pain presented at outpatient Clinic of Physical Medicine, Rheumatology and Rehabilitation Department at Assiut University Hospitals from June 2019 to December 2020. Our study started by 70 patient with chronic shoulder pain 20 of them were missed in follow up period, the range of age from 36 - 56 years, history, clinical examination, Laboratory investigation, and imaging (X-ray or MRI) done for all patient to complete the diagnosis, patient divided randomly into two groups, Group (A) included 25 patients were treated by PRP injection and group (B) included 25 patients were treated by HA injection, both injections were performed under ultrasound (US) guidance. Randomization by sealed envelopes technique, the follow up was at the baseline, 4 weeks and 6 months post injection.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient age >18 years.
- •Patients with chronic shoulder pain more than 6 months not responding to medical treatment or physical therapy.
- •Frozen shoulder.
- •Rotator cuff disorders (partial tear).
排除标准
- •Shoulder joint instability or traumatic shoulder pain.
- •Patients with local infection at the shoulder, systemic infection, or inflammatory disease (e.g., rheumatoid arthritis and hepatitis)
- •Patients with a history of diabetes mellitus and malignancy (either hematological or non-hematological).
- •Pregnancy.
- •Patients on anticoagulant therapy.
- •Injection of shoulder with corticosteroids in the preceding 6 months.
结局指标
主要结局
Shoulder Pain and Disability Index (SPADI) questionnaire
时间窗: 6 months post injection follow up
is a self-introduction administered index designed to measure the effects of different pathologic conditions on the functional status of the shoulder. All items are rated by using a visual analogue scale from "no pain" or "no difficulty" to "worst imaginable pain" or "so difficult it required help". A numerical value was obtained by dividing the scale into 11 segments from 0 to 10 for each item
Visual Analogue Scale (VAS)
时间窗: 6 months post injection follow up
0-10 visual analogue scale of pain
Constant score (CS)
时间窗: 6 months post injection follow up
This scoring system combines physical examination tests with subjective evaluations by the patients. The subjective assessment consists of 35 points and the remaining 65 points are assigned for the physical examination assessment. The subjective assessment includes a single item for pain (15 points) and 4 items for activities of daily living (20 points) (work 4, sport 4, sleep2 and positioning the hand in space 10 points). The objective assessment includes: range of motion (40 points) (forward elevation, 10 points; lateral elevation, 10 points; internal rotation, 10 points; external rotation, 10 points) and power (25 points) (scoring based on the number of pounds of pull the patient can resist in abduction to a maximum of 25 points). The total possible score is therefore 100 points.
次要结局
未报告次要终点
研究者
Eman Mohamed H. ElHakeim
Associate Professor
Assiut University