Achilles Tendon Rupture - Intervention With Electrical Stimulation (C-NMES-ATR)

Karolinska University Hospital

Status: Not yet enrolling

Conditions: Muscle Atrophy; Venous Thromboembolism (VTE); Achilles Tendon Ruptures; Immobilization

Treatments: Device: Neuromuscular Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06601088

C-NMES-ATR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with acute unilateral Achilles tendon rupture
• Included within 10 days after injury.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Control group with standard lower-limb immobilization

No Intervention group

Description:

The control group will be treated according to the standard regimen with a lower limb immobilization in a stable orthosis during eight weeks.

Intervention group with additional Neuromuscular Electrical Stimulation'

Experimental group

Description:

The intervention group will during the eight weeks lower limb immobilization receive an additional intervention with calf Neuromuscular Electrical Stimulation (C-NMES) underneath the orthosis.

Treatment:

Device: Neuromuscular Electrical Stimulation