Calcific Tendinitis of the Rotator Cuff: a Randomized Controlled Trial to the Effects of the Adjuvant Application of Platelet-rich Plasma After Needle Aspiration of Calcific Deposits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale (NRS) pain
研究概览
简要总结
Needle aspiration of calcific deposits (NACD ) is the treatment of choice for calcific tendinitis which does not respond to conservative treatment. NACD is effective in approximately 70% of the patients.When NACD is not effective, surgery is often the only treatment that remains.Surgery, however, is discouraged by th e Dutch guidelines for diagnosing and treating patients with subacromial pain syndrome.Therefore,both patients and the doctors treating those patients will benefit from a more effective minimal invasive treatment for calcific tendinitis.Injection of platelet-rich plasma (PRP) might, considering its positive effect on tissue repair, be a possible solution here.Previous research investigating the effects of PRP on other tendinopathies did, however, show controversial results. The aim of this double-blind randomized controlled trial is to investigate the effect of the adjuvant application of PRP after NACD on pain reduction ,recovery of shoulder function, tendon recovery,resorption of calcific deposits, the percentage of patients with persistent complaints and quality of life.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 yrs
- •clinical manifestions of tendinitis calcarea (pain, stifness, lock sensations, muscle atrophy)
- •persistent pain sympoms >6 months
- •standardized AP x-ray shows calcific deposit of > 5mm & morphologic Type I & II deposits (classification of Gärtner en Simons)
- •ineffective intervention > 2 types of conservative treatment (among which are non-steroidal anti-inflammatory drugs, physiotherapy, local anesthesia injection and/or corticosteroids, extracorporele shock wave therapy)
- •indication and referral for barbotage by orthopeadic surgeon
排除标准
- •age > 55 years
- •morphological type III deposits according to classification of Gärtner and Simons) (as indicated by standardized x-ray AP)
- •bigliani type III acromion, and acromial spur of acromioclavicular osteovyt
- •previous (ineffective) barbotage
- •the existence of other shoulder related injuries next to calcific tendinitis (full-thickness rupture of the rotator cuff, adhesive capsulitis (frozen shoulder), arthrosis of the glenohumeral- or acromioclavicalar joint
- •shoulder joint instability
- •shoulder injury due to trauma or previous shoulder surgeries
- •other types of disorders that could negatively influence the outcomes (rheumatic arthritis. cervical spine disorders, neurological upper extremity disorders, diabetes mellitus, infections, blood disorders, malignity, pregnancy)
- •known allergic responses to one of the medications applied in the current study (lidocaine, bupivacaine, kenacort)
- •usage of anti-coagulants other than ascal of plavix
研究组 & 干预措施
Control group
Regular barbotage
干预措施: Control (Other)
PRP group
PRP during barbotage
干预措施: PRP (Other)
结局指标
主要结局
Numeric Rating Scale (NRS) pain
时间窗: 6 months post barbotage
Score to assess the amount of pain
次要结局
- Constant-Murley Score (CMS)(6 weeks, 3 - 6- 12- 25 months post barbatoge)
- Quality of Life (EQ-5D)(6 weeks, 3- 6- 12- 24 months post barbotage)