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Completed

NCT Number: NCT01833936

E-Stim and Achilles Tendon Repair Study

Calf muscle atrophy (muscle degeneration) is common following Achilles tendon repair due to the immobilization period necessary to ensure optimal healing.

The purpose of this study is to determine if the use of neuromuscular electrical stimulation (NMES) after Achilles tendon surgery will reduce calf muscle atrophy.

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Key information

Conditions

Achilles Tendon Rupture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopedic Foot and Ankle Center

Westerville, Ohio, 43082, United States

About this study

The specific aims of this study are to evaluate the use of electrical stimulation on muscle cross-sectional area and muscle fascicle length following post-operative Achilles tendon surgery.

Patients will be randomly assigned to receive an electrical stimulation unit (Compex®, DJO Global, San Diego, CA). Twenty of these units will be experimental and 20 will be sham.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Any patient who is having surgery to treat an acute Achilles tendon rupture or any surgery that involves reflecting or repairing the distal Achilles tendon.

Exclusion criteria

  • Body mass index (BMI) greater than or equal to 45
  • Inability to consent to participate in clinical research
  • Any patient younger than 18 years old
  • Any limitations that would interfere with the delivery of electrical stimulation including, but not limited to:
  • Presence of an insulin pump
  • Pacemaker, defibrillators or other implanted electrical device
  • Neurostimulation implants
  • History of epilepsy/seizure
  • Current pregnancy. A pregnancy test will be performed for any female prior to surgical intervention per hospital protocol unless she is post-menopausal or has been sterilized.
  • Active malignancy
  • Peripheral neuropathy
  • Diabetes Mellitus
  • Ischemia of lower limbs
  • Active infection
  • Following acute trauma or fracture

Treatment and study plan

Compex® muscle stimulator

Device

The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy.

(inactive) muscle stimulator

Device

A placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.

Primary outcomes

  1. Reduce Calf Muscle Atrophy

    Time frame: Pre-operative, 2 weeks, and 6 weeks post-operative

    Magnetic resonance imaging (MRI) scans were conducted preoperatively and postoperatively at weeks 2 and 6 to measure cross sectional muscle volumes of the calf muscle. By measuring the muscle volume, the investigators hope to show the use of electrical stimulation will reduce calf muscle atrophy.

Sponsors and collaborators

Lead sponsor

Orthopedic Foot and Ankle Center, Ohio

Other

Collaborators

  • DonJoy Orthotics

Registry information

Official study title

The Use of Electrical Stimulation on Muscle Cross Sectional Area and Muscle Fascicle Length Following Postoperative Achilles Tendon Repair

Acronym: E-Stim

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 17, 2013
Registry last updated
Jan 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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