Achilles Tendon Rupture - Intervention With Electrical Stimulation

NCT06601088 | Not Yet Recruiting

• 1 other identifier: C-NMES-ATR
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

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

Keywords

neuromuscular electrical stimulation; duplex ultrasound

Outcome Measures

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

  8 weeks

Secondary Outcomes (13)

• Patient function

  12 months

• Callus production

  8 weeks

• Treatment adherence

  8 weeks

• Adverse events

  8 weeks

• Fasting blood glucose

  8 weeks

Study Arms (2)

Control group with standard lower-limb immobilization

NO INTERVENTION

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

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

Interventions

Neuromuscular Electrical Stimulation DEVICE

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

Also known as: Electrical Stimulation, NMES, C-NMES

Intervention group with additional Neuromuscular Electrical Stimulation'

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Danderyd Hospital: collaborator

Related Publications (5)

• 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.

  PMID: 37887696 BACKGROUND

• 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.

  PMID: 29161465 BACKGROUND

• 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.

  PMID: 32206673 BACKGROUND

• 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.

  PMID: 38796725 BACKGROUND

• 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.

  PMID: 39040046 BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism; Muscular Atrophy

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Paul Ackermann, Prof,MD,PhD

  Karolinska Institutet and Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Belcatro, Res.Nurse

CONTACT

0046-735060907; luigi.belcastro@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: January 15, 2025
• Primary Completion: February 15, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: June 2025 and will be available 2 years
• Access Criteria: On reasonabe request data will be shared.