Acute Achilles Tendon Rupture - Intervention With Neuromuscular Electrical Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 主要终点
- Incidence of Venous thromboembolic events (VTE)
研究概览
简要总结
Acute Achilles tendon rupture (ATR) is an injury that is commonly associated with complications, such as blood clotting, muscle loss and tendon lengthening, all of which affect the long-term outcome and return to sports. These complication are related to the treatment of ATR with lower leg immobilization in a boot.
The investigators aim to demonstrate that an intervention with calf neuromuscular electrical stimulation (C-NMES) during leg immobilization after ATR can 1) reduce blood clots, 2) lower the degree of muscle loss, 3) decrease tendon lengthening and 4) improve long-term outcome.
详细描述
The participants will be divided by chance into two separate groups that compare standard treatment (control group) with C-NMES in addition to standard treatment (intervention group).
A total of 220 patients with diagnosed ATR will be included. The control group will be treated according to the standard regimen with a lower leg immobilization in a stable orthosis during eight weeks. The intervention group will during the eight weeks lower limb immobilization receive an additional intervention with C-NMES underneath the orthosis.
The total number of blood clots, venous thromboembolism incidence, up to mobilization, is defined as deep venous thrombosis (leg blood clots) assessed by screening duplex ultrasound, or pulmonary embolism (lung blood clots). Calf muscle loss, tendon length, and weight-bearing, will be studied at two and eight weeks. At six weeks and 12 months, validated self-reported function (ATRS) and self-reported health, return to sports, calf muscle function, and tendon length will be recorded for comparison between the two treatment groups. Secondary outcomes are coagulation factors, healing biomarkers and cardiovascular biomarkers.
The results of this study should contribute to an improved treatment regimen after ATR that allows for a safer and quicker return to activity and sports. Adjuvant NMES can readily be implemented in daily healthcare to lower complication risks, improve healing, reduce healthcare costs and improve return to sports.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with acute unilateral Achilles tendon rupture
- •Included within 10 days after injury.
排除标准
- •Inability to give consent to participate,
- •ongoing treatment with anticoagulants,
- •known allergy to contrast agents,
- •planned follow-up at another hospital,
- •inability to follow instructions,
- •known renal failure,
- •heart failure with pitting edema,
- •thrombophlebitis,
- •thromboembolic disease within the last 3 months,
- •previous surgery of the tendon,
- •known malignancy,
- •hemophilia,
- •pregnancy,
- •treatment with high doses of acetylsalicylic acid.
结局指标
主要结局
Incidence of Venous thromboembolic events (VTE)
时间窗: 8 weeks
VTE, is defined as symptomatic/ asymptomatic DVT assessed at the end of immobilization, i.e. 8 weeks, by compression duplex ultrasound (CDU) screening, or symptomatic pulmonary embolism detected by computer tomography. Assessors of CDU will be skilled ultrasonographists, masked to the treatment allocation. The CDU-examination will document absence/presence of thrombus in the calf, popliteal and femoral veins separately
次要结局
- Patient function(12 months)
- Callus production(8 weeks)
- Treatment adherence(8 weeks)
- Adverse events(8 weeks)
- Fasting blood glucose(8 weeks)
- Cholesterol levels(8 weeks)
- Blood pressure(8 weeks)
- Muscle atrophy(12 months)
- Tendon lengthening(12 months)
- Patient-reported outcome - ATRS(12 months)
- Patient-reported outcome - EuroQol (EQ-5D-5L)(12 months)
- Blood-flow quantification(8 weeks)
- Coagulation factors(8 weeks)
研究者
Paul Ackermann
Professor
Karolinska University Hospital