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Achilles Tendon RupturesC-NMES-ATRNCT06601088

Achilles Tendon Rupture - Intervention With Electrical Stimulation

A study testing Neuromuscular Electrical Stimulation in people with Achilles Tendon Ruptures and Immobilization, run by Karolinska University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Neuromuscular Electrical Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
No sites listed yet
Study dates
15 Jan 2025to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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,
Show all 14Show fewer
  • 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 locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Luigi Belcatro, Res.Nurse contact

0046-735060907

luigi.belcastro@regionstockholm.se

About this study

Official title: 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.

Read the 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.

Being tested
Neuromuscular Electrical Stimulation
Keywords
neuromuscular electrical stimulation, duplex ultrasound
Medical subject headings
Venous Thromboembolism, Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular Electrical StimulationDevice

    Also called Electrical Stimulation, NMES, C-NMES

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

Study groups in NCT06601088
Study groupRoleWhat they receive
Control group with standard lower-limb immobilizationNo interventionThe 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'ExperimentalThe intervention group will during the eight weeks lower limb immobilization receive an additional intervention with calf Neuromuscular Electrical Stimulation (C-NMES) underneath the orthosis.
Receives: Device: Neuromuscular Electrical Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 8 weeks

Secondary outcomes (13)

  1. Patient function

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

    Measured: 12 months

  2. Callus production

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

    Measured: 8 weeks

  3. Treatment adherence

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

    Measured: 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.

    Measured: 8 weeks

  5. Fasting blood glucose

    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.

    Measured: 8 weeks

  6. Cholesterol levels

    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.

    Measured: 8 weeks

  7. Blood pressure

    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.

    Measured: 8 weeks

  8. Muscle atrophy

    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.

    Measured: 12 months

  9. Tendon lengthening

    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.

    Measured: 12 months

  10. Patient-reported outcome - ATRS

    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].

    Measured: 12 months

  11. Patient-reported outcome - EuroQol (EQ-5D-5L)

    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.

    Measured: 12 months

  12. Blood-flow quantification

    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.

    Measured: 8 weeks

  13. Coagulation factors

    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.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start15 Jan 2025 (estimated)
  3. Primary completion15 Feb 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06601088
Sponsor's protocol ID
C-NMES-ATR
Acronym
C-NMES-ATR
Status last verified
Sep 2024
First submitted
7 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: On reasonabe request data will be shared.

Publications

  • Alharbi A, Li J, Womack E, Farrow M, Yarar-Fisher C. The Effect of Lower Limb Combined Neuromuscular Electrical Stimulation on Skeletal Muscle Signaling for Glucose Utilization, Myofiber Distribution, and Metabolic Function after Spinal Cord Injury. Int J Environ Res Public Health. 2023 Oct 21;20(20):6958. doi: 10.3390/ijerph20206958.

    PubMed 37887696

  • Hajibandeh S, Hajibandeh S, Antoniou GA, Scurr JR, Torella F. Neuromuscular electrical stimulation for the prevention of venous thromboembolism. Cochrane Database Syst Rev. 2017 Nov 21;11(11):CD011764. doi: 10.1002/14651858.CD011764.pub2.

    PubMed 29161465

  • Aufwerber S, Heijne A, Edman G, Silbernagel KG, Ackermann PW. Does Early Functional Mobilization Affect Long-Term Outcomes After an Achilles Tendon Rupture? A Randomized Clinical Trial. Orthop J Sports Med. 2020 Mar 16;8(3):2325967120906522. doi: 10.1177/2325967120906522. eCollection 2020 Mar.

    PubMed 32206673

  • Aufwerber S, Svedman S, Silbernagel KG, Ackermann PW. Long-term patient outcome is affected by deep venous thrombosis after Achilles tendon rupture repair. Knee Surg Sports Traumatol Arthrosc. 2024 Aug;32(8):2184-2193. doi: 10.1002/ksa.12240. Epub 2024 May 26.

    PubMed 38796725

  • Svedman S, Marcano A, Ackermann PW, Fellander-Tsai L, Berg HE. Acute Achilles tendon ruptures between 2002-2021: sustained increased incidence, surgical decline and prolonged delay to surgery-a nationwide study of 53 688 ruptures in Sweden. BMJ Open Sport Exerc Med. 2024 Jul 18;10(3):e001960. doi: 10.1136/bmjsem-2024-001960. eCollection 2024.

    PubMed 39040046

Questions about this trial

What is this clinical trial studying?

A study testing Neuromuscular Electrical Stimulation in people with Achilles Tendon Ruptures and Immobilization, run by Karolinska University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Luigi Belcatro, Res.Nurse (0046-735060907, luigi.belcastro@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Venous thromboembolic events (VTE) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06601088, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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