Phase 1/2 Prospective Double-blind, Placebo-controlled Randomized Clinical Trial Using Losartan to Treat Grade II and III Hamstring Strains
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Recovery of Hamstring Structure
研究概览
简要总结
The goal of this study is to determine safety and tolerability of Losartan when used for treatment of an acute grade II or III hamstring strain and determining the effect of losartan on recovery of hamstring muscle function. Subjects will be adults age 18 and older with grade 2 or 3 hamstring injury who participate in greater than 100 hours per year in Level 1 or Level 2 athletics or have a similar activities or physical work load (e.g. military personnel). Subjects will undergo examination, MRI, and functional assessment before, during, and after 4 weeks of losartan (50mg QD) or placebo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- •Have had previous hamstring injury on the same side or chronic symptoms;
- •Have an injury that requires surgical intervention (e.g. avulsion with associated bony involvement, grade III complete tears);
- •Have concurrent lower back symptoms;
- •Pregnant or breast feeding;
- •Is a smoker;
- •Has contraindications for Losartan therapy (hypersensitivity to Losartan, hepatic involvement);
- •Currently use angiotensin I converting enzyme inhibitor (ACEI)/ Angiotensin II receptor blocker (ARB);
- •Have hypertension (blood pressure greater than or equal to 140 mmHg systolic pressure or greater than or equal to 90 mmHg diastolic pressure);
- •Have hypotension (blood pressure less than or equal to 90 mmHg systolic pressure or less than or equal to 60 mmHg diastolic pressure);
- •Have orthostatic hypotension defined as a drop in systolic pressure greater than or equal to 2 0mmHg or a drop in diastolic blood pressure greater than or equal to 10 mmHg or reports of lightheadedness or dizziness upon standing;
- •Have diabetes mellitus, cardiovascular, renal or hepatic co-morbidities;
- •Sickle cell anemia/trait;
- •Have contraindications for MRI - including:
- •Prior surgery for an aneurysm;
- •Have cardiac pacemaker;
- •Have metal fragments in the eyes, brain, or spinal cord from shrapnel, metal work, or welding;
- •Have surgical implants, such as ear implant or neurostimulator;
- •Have a history of claustrophobia;
- •Have a history of not tolerating previous MRI scans without medication
研究组 & 干预措施
Losartan
Subjects will taken 50mg of losartan per day for 4 weeks
干预措施: Losartan (Drug)
Placebo
Subjects will be given placebo to replicate appearance of losartan pills. Placebo pill will be taken once per day.
干预措施: Placebo (Drug)
结局指标
主要结局
Recovery of Hamstring Structure
时间窗: 6 months
For specific aim 2, hamstring structure was measured in terms of the volume of fibrosis at 6 month MRI, as such smaller volume of fibrosis represents greater healing of the hamstring muscle. Hamstring structure was also determined by comparing the change of pre-treatment volume of the injury on the baseline MRI to the volume of fibrosis on the 6 month MRI.
Recovery of Hamstring Muscle Function
时间窗: 6 weeks; 6 months
For specific aim 2, hamstring muscle function of the injured leg was measured and compared to the contralateral leg using isometric hamstring force at 30, 60, and 90 degrees of knee flexion at 6 weeks and 6 months. Data are expressed as a Limb Symmetry Index (LSI), which is the percent force of the injured hamstring compared to the force of the non-injured hamstring muscle.
Return to Prior Level of Function
时间窗: 12 months
Return to prior level of function will be measured by the number of days from injury to full, unrestricted return to practice. This could have occurred at any timepoint after 6 weeks, so this did not necessarily occur at 12 months but it was monitored until the 12 month timepoint.
Reported Effects of Losartan for Hamstring Injury for Safety and Tolerability
时间窗: 4 weeks
Directly related to specific aim 1- Side effects, safety, and tolerability will be monitored by measuring vital signs, lab values via blood work, and number of adverse events, serious adverse events, and patient reported side effects.
Recurrence of Injury
时间窗: 12 months
Number of recurrent injuries will be monitored during the duration of the subjects participation.
次要结局
- Recovery of Hamstring Structure(6 months)
- Return to Prior Level of Function(4 Weeks, 6 Weeks, 3 Months, 4 Months, 6 Months, 12 Months)
- Recovery of Hamstring Flexibility(6 weeks; 6 months)
- Recovery of Hamstring Muscle Function(6 weeks, 6 months)
研究者
James J. Irrgang
PT, PhD
University of Pittsburgh