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

September 15, 2024 updated by: Paul Ackermann, Karolinska University Hospital

Acute Achilles Tendon Rupture - Intervention With Neuromuscular Electrical Stimulation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Device: Neuromuscular Electrical Stimulation
Patients will be instructed to apply the wearable NMES-therapy continuously, both day and night at least 10h/daily.
Other Names:
  • NMES
  • Electrical Stimulation
  • C-NMES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Venous thromboembolic events (VTE)
Time Frame: 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
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient function
Time Frame: 12 months
Functional evaluation of healing will be performed by the validated heel-rise test at one-year post-injury.
12 months
Callus production
Time Frame: 8 weeks
Callus production will be assessed at eight weeks using microdialysis followed by quantification of procollagens for tendon healing.
8 weeks
Treatment adherence
Time Frame: 8 weeks
Treatment adherence to allocated treatment, NMES, will be registered by the patient and by the device.
8 weeks
Adverse events
Time Frame: 8 weeks
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.
8 weeks
Fasting blood glucose
Time Frame: 8 weeks
Fasting blood glucose will be assessed at inclusion and at eight weeks. A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) will be considered normal. A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) will be considered considered prediabetes. If it is 126 mg/dL (7 mmol/L) or higher it will be considered diabetic.
8 weeks
Cholesterol levels
Time Frame: 8 weeks
Will be assessed at inclusion and at eight weeks. Total cholesterol less than 200 Mmol/l will be considered good. Total cholesterol 200-239 Mmol/l will be considered moderately elevated. Total cholesterol 240 Mmol/l or higher will be considered high.
8 weeks
Blood pressure
Time Frame: 8 weeks

Systolic blood pressure less than 120 mmHg and diastolic blood pressure less than 80 mmHg will be considered optimal.

Systolic blood pressure between 120-129 mmHg and diastolic blood pressure between 80-84 mmHg will be considered normal.

Systolic blood pressure between 130-139 mmHg and diastolic blood pressure between 85-89 mmHg will be considered slightly high.

Systolic blood pressure greater or equal to 140 mmHg and diastolic blood pressure greater or equal to 90 mmHg will be considered high.
8 weeks
Muscle atrophy
Time Frame: 12 months
At 2 and 6 weeks and 6 and 12 months postoperatively, B-mode ultrasound imaging will be performed to assess the cross-sectional area (CSA) of the Achilles tendon, the gastrocnemius CSA, as well as the thickness of soleus. The injured and healthy sides will be compared.
12 months
Tendon lengthening
Time Frame: 12 months
At 2 and 6 weeks and 6 and 12 months postoperatively, B-mode ultrasound imaging will be performed to assess the length of the Achilles tendon. The injured and healthy sides will be compared. A larger difference between the sides will be considered a worse outcome.
12 months
Patient-reported outcome - ATRS
Time Frame: 12 months
The validated Achilles Tendon total Rupture Score (ATRS) will be assessed at 6 and 12 months. [0-100, a higher score mean a better outcome].
12 months
Patient-reported outcome - EuroQol (EQ-5D-5L)
Time Frame: 12 months
The validated EuroQol (EQ-5D-5L), will be assessed at 6 and 12 months. [A five-digit code will be generated, where each digit will be between 1-5, a lower digit in each position mean a better outcome in that dimension]. The five-digit code will generate an index between 0-1, where a lower value is worse outcome. The index will be compared with a country specific index.
12 months
Blood-flow quantification
Time Frame: 8 weeks
VTE-preventive mechanisms will be analyzed at the eight week visit by assessments by blood-flow quantification using ultrasound. Peak popliteal/femoral blood velocity (cm/second) will be calculated using custom ultrasound software.
8 weeks
Coagulation factors
Time Frame: 8 weeks
VTE-preventive mechanisms will be analyzed at the baseline and eight week visit by assessments of coagulation factors. Overall hemostatic potential (OHP), D-dimer, endogen trombin potential, fibrinogen, trombin antitrombin complex, plasmin antiplasmin complex, will be assessed in blood samples. The percentage increase/decrease between baseline and eight weeks assessment will be compared between groups.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Danderyd Hospital

Investigators

  • Principal Investigator: Paul Ackermann, Prof,MD,PhD, Karolinska Institutet and Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2025

Primary Completion (Estimated)

February 15, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

September 7, 2024

First Submitted That Met QC Criteria

September 15, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 15, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-NMES-ATR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

On reasonabe request data will be shared.

IPD Sharing Time Frame

June 2025 and will be available 2 years

IPD Sharing Access Criteria

On reasonabe request data will be shared.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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