Randomized Controlled Trial of Home-based Versus Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Victorian Institute of Sports Assessment self-administered Achilles questionnaire (VISA-A)
研究概览
简要总结
The goal of this prospective randomized controlled trial is to compare the effectiveness of a home-based exercise protocol to formal physical therapy in patients who have been diagnosed with Achilles tendinopathy. The null hypothesis is that there will be no difference in the treatment outcomes between patients with Achilles tendinopathy who participate in a home-based program versus patients with Achilles tendinopathy who undergo formal physical therapy. Participants will be randomized to a 12-week home-based or formal physical therapy protocol and asked to complete brief outcomes surveys at their initial visit, and at 6 weeks, 12 weeks, 6 months, and 1 year after their initial visit.
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
- 是
入选标准
- •Must be 18 years of age
- •Must have a new diagnosis of Achilles tendinopathy that has presented with pain, thickening and tenderness at the mid substance of the Achilles tendon
- •Symptoms present for at least 6 weeks
排除标准
- •Patients with insertional Achilles pain or tenderness or concomitant plantar foot pain
- •Patients who have had prior treatment with home eccentric stretching or physical therapy
- •Patients who have prior diagnosis and treatment for Achilles tendinopathy
- •Patients with history of injection (corticosteroid or sclerosing agents) to the Achilles tendon
- •Patients with inflammatory arthritis
- •Recent fluoroquinolone antibiotics (these agents are known to alter Achilles tendon physiology)
- •Patients who have had prior foot or ankle surgery
- •Individuals that do not speak English
- •Bilateral disease
- •Pregnant women
结局指标
主要结局
Victorian Institute of Sports Assessment self-administered Achilles questionnaire (VISA-A)
时间窗: Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment
Achilles tendon-specific questionnaire that asks about patient pain, functional status, and activity level.
次要结局
- PROMIS Depression (4a)(Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment)
- PROMIS Pain Interference (4a)(Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment)
- PROMIS Pain Intensity (3a)(Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment)
- Patient Acceptable Symptom State Questionnaire(Initial presentation, 6 weeks, 12 weeks, 6 months, and one year from the start of treatment)
研究者
Christopher Chiodo
MD
Brigham and Women's Hospital