Achilles Tendon Rupture - Intervention With Electrical Stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2026-12-30

Brief Summary

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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.

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Detailed Description

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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

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Achilles Tendon Ruptures Immobilization Venous Thromboembolism (VTE) Muscle Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group with standard lower-limb immobilization

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group with additional Neuromuscular Electrical Stimulation'

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.

Group Type EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type DEVICE

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

Interventions

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Neuromuscular Electrical Stimulation

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

Intervention Type DEVICE

Other Intervention Names

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Electrical Stimulation NMES C-NMES

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No