Clinical trial NCT06601088: Achilles Tendon Rupture - Intervention With Electrical Stimulation
Official title: Acute Achilles Tendon Rupture - Intervention With Neuromuscular Electrical Stimulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Achilles Tendon Ruptures
Immobilization
Venous Thromboembolism (VTE)
Muscle Atrophy
Keywords: neuromuscular electrical stimulation
duplex ultrasound
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Danderyd Hospital
First posted: 2024-09-19
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Venous thromboembolic events (VTE)
timeFrame: 8 weeks
Secondary outcomes:
measure: Patient function
timeFrame: 12 months
measure: Callus production
timeFrame: 8 weeks
measure: Treatment adherence
timeFrame: 8 weeks
measure: Adverse events
timeFrame: 8 weeks
measure: Fasting blood glucose
timeFrame: 8 weeks
measure: Cholesterol levels
timeFrame: 8 weeks
measure: Blood pressure
timeFrame: 8 weeks
measure: Muscle atrophy
timeFrame: 12 months
measure: Tendon lengthening
timeFrame: 12 months
measure: Patient-reported outcome - ATRS
timeFrame: 12 months
measure: Patient-reported outcome - EuroQol (EQ-5D-5L)
timeFrame: 12 months
measure: Blood-flow quantification
timeFrame: 8 weeks
measure: Coagulation factors
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet and Karolinska University Hospital
name: Paul Ackermann, Prof,MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.