Prospective Single-Arm Observational Study on the Efficacy and Safety of Ultrasound-Guided Peritendinous Injection of Low-Molecular-Weight Hyaluronic Acid (Hyalotend®; 500-730 kDa) for Chronic Non-Calcific Supraspinatus Tendinopathy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- QuickDASH questionary
研究概览
简要总结
This study aims to evaluate whether ultrasound-guided injections of low-molecular-weight hyaluronic acid (Hyalotend®) can safely reduce pain and improve shoulder function in people with chronic non-calcific supraspinatus tendinopathy. Participants will receive two injections as part of their treatment and will be followed over time to assess changes in pain, shoulder function, medication use, treatment satisfaction, and any side effects. The information collected may help improve the treatment of this condition in future patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥18 years.
- •Clinical and ultrasound-confirmed diagnosis of chronic (>12 weeks) supraspinatus tendinopathy.
- •No structural tendon tear, confirmed by ultrasound.
- •No tendon calcification, confirmed by ultrasound.
- •Previous failure of conservative treatment, including physical therapy and/or analgesic or anti-inflammatory medication.
- •Written informed consent provided.
排除标准
- •Partial- or full-thickness supraspinatus tendon tear identified by ultrasound.
- •Calcific supraspinatus tendinopathy identified by ultrasound.
- •Subacromial-subdeltoid bursitis identified by ultrasound
- •Previous treatment with extracorporeal focus shock wave therapy within the last 3 months.
- •Previous corticosteroid or platelet-rich plasma (PRP) injection within the last 3 months.
- •History of hypersensitivity or allergy to hyaluronic acid or any of its components.
- •Uncontrolled systemic disease.
- •Other chronic rheumatologic or autoimmune diseases.
- •Pregnancy or breastfeeding.
结局指标
主要结局
QuickDASH questionary
时间窗: 1. Before infiltrations 2. 4 weeks after second infiltration 3. 12 weeks after second infiltration
The QuickDASH is a validated patient-reported outcome measure used to evaluate changes in upper extremity symptoms and functional disability after treatment.
Constant-Murley questionary
时间窗: 1. Before infiltrations 2. 4 weeks after second infiltration 3. 12 weeks after second infiltration
The Constant-Murley Score is a validated shoulder-specific outcome measure used to assess changes in pain, activities of daily living, range of motion, and shoulder strength following treatment
Visual Analog Scale
时间窗: 1. Before infiltrations 2. 4 weeks after second infiltration 3. 12 weeks after second infiltration
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS). Scores range from 0 (no pain) to 10 (worst imaginable pain), with lower scores indicating less pain.
次要结局
- Secondary effects(-immediately after the first intervention -immediately after the second intervention -4 weeks after intervention -12 weeks after intervention)
- Analgesic and nonsteroidal anti-inflammatory drug (NSAID) consumption will be recorded throughout the study.(1. Before infiltrations 2. 4 weeks after second infiltration 3. 12 weeks after second infiltration)
- Patient global satisfaction with the received treatment will be assessed.(12 weeks after second infiltration)
研究者
Marcos Rufino Navarro
Resident Physician in Physical Medicine and Rehabilitation
University Hospital of the Nuestra Señora de Candelaria