Collagen and PRP in Partial Thickness Rotator Cuff Injuries: Friends or Only Indifferent Neighbors: Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 24 weeks
研究概览
简要总结
The aim of the trial is comparison of the effectiveness of three methods of conservative treatment in partial thickness rotator cuff injury (PTRCI): collagen with PRP injections, PRP injections alone and collagen injections alone.
详细描述
BACKGROUND: Rotator cuff injury (RCI) occupy third place in the population among the musculoskeletal system pathologies (16%) after low back pain (25%) and knee pain (19%). Partial thickness RCI (PTRCI) is the sum of degenerative, overload and microtrauma processes and their incidence increases significantly with age (up to 30% over 60). One of the factors contributing to the injury is a negative collagen balance and slowed tendon metabolism in proportion to its blood supply disorders. Conservative treatment of PTRCI of degenerative origin is the first choice management, but there are no clear guidelines. External supply of collagen and PRP could potentially counteract these processes.
AIM: Comparison of the effectiveness of three treatment concepts: collagen with PRP, PRP alone, collagen alone in the treatment of PTRCI.
DESIGN: Randomized prospective trial without blinding SETTING: Open study for outpatients, single center study POPULATION: local population METHODS: Three groups of patients (each group 30 patients) with PTRCI confirmed by ultrasound (N=90). The assessment of the supraspinatus tendon (SSP) in standard position of internal rotation of the upper limb for ultrasound examination, assessment of the thickness of the RC in cross-section (mm). Each group treated by three ultrasound guided injections into the shoulder bursa every consecutive week: Group A - collagen (3 amp Collagen MD Shoulder) together with PRP (2ml); Group B - collagen alone (3 amp Collagen MD Shoulder); Group C - PRP alone. All patients were allowed to continue rehabilitation protocol. Primary control tools: NRS, QuickDash, EQ-5D-5L in control points: IA (initial assessment), 6, 12 and 24 weeks after last injection. Secondary control tools: percentage of patients where the RC continuity were preserved and percentage of patients who had ultrasonographic signs of RC regeneration (crossection width increase, improvement of echogenicity) during the observation period between W0 and 24 weeks.
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
- None
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
- •clinical signs and symptoms of rotator cuff pathology
- •an adult person consenting to injections
- •partial thickness rotator cuff injury confirmed by ultrasound examination without coexisting severe pathologies (systemic inflammatory disease, malignancy, severe stage OA)
- •no traumatic event
- •no injections or any other local treatment in previous 1 month
排除标准
- •full thickness rotator cuff injury
- •acute, traumatic injuries requiring surgical treatment
- •coexisting injuries of the shoulder joint requiring other intervention
- •severe pathologies of the shoulder of another origin (systemic inflammatory disease, malignancy, severe stage OA)
- •no consent
结局指标
主要结局
QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 24 weeks
时间窗: Change from baseline to 24 weeks
Range: 0 (the best outcome) - 100 (the worst outcome).
Change in EQ-5D-5L index from baseline to 24 week
时间窗: Change from baseline to 24 weeks
EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.
次要结局
- QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 12 weeks(Change from baseline to 12 weeks)
- Preservation of rotator cuff continuity in ultrasound imaging(Change from baseline to 24 weeks)
- Change in EQ-5D-5L index from baseline to 12 week(Change from baseline to 12 weeks)
- Pain according to Numeric Rating Scale (NRS)(Change from baseline to 24 weeks)
- Width of rotator cuff in ultrasound imaging(Change from baseline to 24 weeks)
- Regenaration of rotator cuff in ultrasound imaging(24 weeks)
- Change in EQ-5D-5L index from baseline to 6 week(Change from baseline to 6 weeks)
- QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 6 weeks(Change from baseline to 6 weeks)
研究者
Piotr Godek
Principal Investigator
Sutherland Medical Center