Effectiveness of Hydrolyzed Collagen Peptide Injection for the Treatment of Collateral Ligament Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- WOMAC
研究概览
简要总结
Conducted by Binh Luu Thi, Lan Tran Thi, and Minh Hang Hoang Thi at Thai Nguyen National Hospital, the study investigates a new approach to treating persistent collateral ligament pain, common among athletes. The research examines the therapeutic use of hydrolyzed collagen peptide injections, a treatment that addresses pain and inflammation in ways previous methods have not.
The study involves a randomized controlled trial with 62 patients, all diagnosed with inflammation in the collateral ligament site. The patients are split into two groups: one receiving collagen injections alongside oral painkillers and the other receiving depo-medrol injections with oral painkillers.
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
- Single (Participant)
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 above 18 years,
- •lateral knee pain with a duration of 3 months or longer,
- •ultrasound evidence of inflammation of the femoral condyle attachment point,
- •agreement to participate in the study
排除标准
- •infection,
- •dermatitis at the site of the inflammation,
- •damage to surrounding knee structures,
- •history of chronic inflammatory arthritis (such as gout or rheumatoid arthritis),
- •local corticosteroid injection within 3 months before participating in the study.
研究组 & 干预措施
Collagen Peptide Group
The Collagen Peptide Group (31 patients) received oral pain relievers (paracetamol and anti-inflammatory NSAIDs) for 3-7 days (if the pain was severe) and one injection of collagen peptide solution (Tiss'You, Republic of San Marino) at the site of the inflamed ligament attachment point (femoral condyle).
干预措施: Arthrys (Collagen Peptide solution) (Device)
Cortison Group
The Cortison Group (31 patients) received oral painkillers (paracetamol and anti-inflammatory NSAIDs) for 3-7 days (if the pain was severe) and one injection of depo-medrol at the site of inflamed ligament attachment point (femoral condyle), combined with oral slow-acting symptomatic drugs (glucosamine 1500mg, atrodar 50mg) for 3 consecutive months.
干预措施: Depo medrol (Drug)
结局指标
主要结局
WOMAC
时间窗: 6 months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) assessing functionality from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status.
次要结局
- VAS (Visual Analogue Pain)(Baseline, 3 months, 6 months)
- Ultrasound(Baseline, 3 months, 6 months)
- Likert(Baseline, 6 months)
- WOMAC(Baseline, 3 months)
研究者
Prof. Binh Luu Thi
Prof
Tiss'You srl