Pilot Investigation to Evaluate Effectiveness of Shockwave Therapy, a Combination of Shockwave Therapy and Photobiomodulation and Physical Therapy in the Management of Non-insertional Achilles Tendinopathy: A Randomized Control Trial With Elective Cross-Over Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Calf Raises Performed to Fatigue and Inability to Continue
研究概览
简要总结
This is a randomized control trial with an elective cross over after three months to evaluate three different treatments in the management of non-insertional Achilles Tendinopathy. The treatment methods include physical therapy, shockwave therapy and photobiomodulation.
详细描述
This is a randomized control study with an elective cross over. In part 1 of the study participants will be randomized into one of three treatment arms: 1) physical therapy only; 2) physical therapy and shockwave therapy; 3) physical therapy, shockwave therapy and photobiomodulation. At 3 months, patients can choose to switch to a different treatment arm than they were initially randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of mid-portion Achilles tendinopathy (including both unilateral and bilateral)
- •Running is the pre-injury primary form of physical activity and pre-injury would complete on average 10 miles per week or more of running
- •VISA-A <80 at baseline to be eligible
排除标准
- •Less than 3 months of symptoms
- •Primary insertional Achilles tendinopathy
- •Diagnosis of rheumatological disease/connective tissue condition, symptomatic arthritis of foot and ankle, a primary running related injury outside Achilles tendinopathy, other contraindications to PBMT or SWT
- •Have received SWT within the past 3 months to their Achilles
- •Prior injection within 3 months
- •Currently enrolled in PT for more than 4 weeks for their condition
- •Women who are pregnant.
- •known history of Achilles tendon tear
- •currently taking oral steroid or fluoroquinolone class of antibiotics
结局指标
主要结局
Calf Raises Performed to Fatigue and Inability to Continue
时间窗: Difference from 0-3 months
Calf raises performed to fatigue and inability to continue
Ultrasound Measurements in Change of Cross Sectional Area
时间窗: Difference from 0-3 months
Changes in the cross-sectional area measured on ultrasound
Victorian Institute of Sports Assessment (VISA-A) Questionnaire
时间窗: change from baseline to 3 month follow-up measure
Victorian Institute of Sports Assessment Questionnaire. The score of the questionnaire ranges from 0-100, where 100 is a person who is completely asymptomatic (better).
次要结局
未报告次要终点
研究者
Adam Tenforde
Principal Investigator
Spaulding Rehabilitation Hospital