Effectiveness of Lyophilized Growth Factors for Subacromial Impingement: Randomized Double Blind Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- VAS (Visual Analogue Scale)
研究概览
简要总结
The aim of this study is to evaluate the efficacy of ultrasound-guided injection of platelet-derived lyophilized growth factors in treatment of subacromial impingement.
详细描述
A new patented product named lyophilized Growth Factors has been developed. It is a novel advanced and refined form of conventional platelet-rich plasma. Effectiveness of intra-articular lyophilized Growth Factors injection has been studied in thirty patients with symptomatic primary knee osteoarthritis and has shown encouraging results regarding improvement of pain, stiffness and function in addition to decreasing knee effusion.
The lack of good quality evidence to support the efficacy of injecting platelet-derived lyophilized growth factors in treatment of subacromial impingement highlights the need for thorough evaluation of the outcome of this novel therapeutic option in patients with subacromial impingement.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically:
- •Anterolateral shoulder and/or lateral upper arm pain.
- •Painful arc of motion between 70° and 120°.
- •Positive impingement sign (Neer's test or Hawkins-Kennedy test).
- •Ultrasonographically:
- •The elicitation of a transient arc of pain during shoulder abduction which coincides with passage of the supraspinatus insertion beneath the coraco-acromial arch.
排除标准
- •History of shoulder surgery, fracture, dislocation or subluxation.
- •Patients with full-thickness rotator cuff tear, weakness on arm elevation, or positive "drop arm sign".
- •Patients who have been diagnosed with a frozen shoulder or degenerative arthropathy of the glenohumeral joint.
- •Patients with disorders of the cervical spine or upper extremity that have a significant impact on the shoulder
- •Patients with diabetes mellitus, rheumatoid arthritis, hypothyroidism or other painful or function limiting disorders of the shoulder.
- •Significant cardiovascular, renal or hepatic disease.
- •Active infection in the area to be treated.
结局指标
主要结局
VAS (Visual Analogue Scale)
时间窗: 8 weeks
Pain assessment scale. The minimum value is zero and the maximum value is 10. A higher score indicates a worse outcome.
SPADI (Shoulder Pain and Disability Index)
时间窗: 8 weeks
An index measuring the impact of shoulder pathology in terms of pain and disability. Total pain score: / 50 x 100 = % Total disability score: / 80 x 100 = % Total Spadi score: / 130 x 100 = % (Note: If a person does not answer all questions divide by the total possible score, eg. if 1 question missed divide by 120) The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst). A higher score indicates a worse outcome.
次要结局
未报告次要终点