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Achilles Tendon Rupture - Intervention With Electrical Stimulation

ConditionsAchilles Tendon RupturesImmobilizationVenous Thromboembolism (VTE)Muscle Atrophy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKarolinska University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with acute unilateral Achilles tendon rupture

Included within 10 days after injury.

Disqualifiers

Inability to give consent to participate,

ongoing treatment with anticoagulants,

known allergy to contrast agents,

planned follow-up at another hospital,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neuromuscular Electrical Stimulation

    Device

    Patients will be instructed to apply the wearable NMES-therapy continuously, both day and night at least 10h/daily.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Control group with standard lower-limb immobilizationNo intervention 0 interventions
Group B: Intervention group with additional Neuromuscular Electrical Stimulation'Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Venous thromboembolic events (VTE)

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

Time frame
8 weeks

Secondary outcomes

1

Patient function

Functional evaluation of healing will be performed by the validated heel-rise test at one-year post-injury.

Time frame
12 months
2

Callus production

Callus production will be assessed at eight weeks using microdialysis followed by quantification of procollagens for tendon healing.

Time frame
8 weeks
3

Treatment adherence

Treatment adherence to allocated treatment, NMES, will be registered by the patient and by the device.

Time frame
8 weeks
4

Adverse events

Adverse events that will be registered are 1) Any damage to the skin of the legs including infection. 2) Any reasons for prematurely stopping the NMES. 3) Any fall associated with significant injury occurring within 6 weeks of enrollment. The frequency of the adverse events of each group will be presented.

Time frame
8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska University Hospital

Lead sponsor

Danderyd Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: