Phase 2 Study of Dextrose Injection for Sport-Limiting Osgood Schlatter Disease in Adolescents.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
研究概览
简要总结
Objective: To examine the potential of dextrose injection versus lidocaine injection versus supervised usual care to change pain/function/activity levels in adolescent athletes with Osgood-Schlatter Disease (OSD).
详细描述
Patients and methods: Girls ages 9-15 years old and boys ages 10-17 years old will be assigned to either therapist-supervised usual care, or to double-blind injection of 1% lidocaine solution with or without 12.5% dextrose. Injections will be administered monthly for three months. All subjects will then be offered dextrose injections monthly as needed. Change in the Nirschl Pain Phase Scale (NPPS) will serve as the primary outcome measure.
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
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:9-15 year old girls and 10-17 year old boys
- •Pain Location: Anterior knee.
- •Sport Type: Jumping or kicking sport.
- •Team Member with Coach: Member of and organized team with a coach.
- •Imitation of exact pain and precise location to the tibial tuberosity with a single leg squat.
- •At least 2 months of formal and gently progressive hamstring stretching, quads strengthening, and gradual sports reintroduction.
- •Pain with sport at least 3 months.
排除标准
- •Patellofemoral crepitus
- •Patellar origin tenderness
研究组 & 干预措施
Dextrose
干预措施: Dextrose Injection (Procedure)
Usual Care
干预措施: Usual Care (Other)
Lidocaine
干预措施: Lidocaine Injection (Procedure)