NCT06601088

Achilles Tendon Rupture - Intervention With Electrical Stimulation

Acute Achilles Tendon Rupture - Intervention With Neuromuscular Electrical Stimulation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Achilles Tendon Ruptures
• Immobilization
• Venous Thromboembolism (VTE)
• Muscle Atrophy

Interventions

Type	Name	Description
DEVICE	Neuromuscular Electrical Stimulation	Patients will be instructed to apply the wearable NMES-therapy continuously, both day and night at least 10h/daily.

Timeline

• Start date: 2025-01-15
• Primary completion: 2026-02-15
• Completion: 2026-12-30
• First posted: 2024-09-19
• Last updated: 2024-09-19