E-Stim and Achilles Tendon Repair Study (E-Stim)

December 12, 2017 updated by: Christopher Hyer, Orthopedic Foot and Ankle Center, Ohio

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

  • United States
    • Ohio
      • Westerville, Ohio, United States, 43082
        • Orthopedic Foot and Ankle Center

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  1. Body mass index (BMI) greater than or equal to 45
  2. Inability to consent to participate in clinical research
  3. Any patient younger than 18 years old

  4. Any limitations that would interfere with the delivery of electrical stimulation including, but not limited to:

    1. Presence of an insulin pump
    2. Pacemaker, defibrillators or other implanted electrical device
    3. Neurostimulation implants
    4. History of epilepsy/seizure
    5. 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.
    6. Active malignancy
    7. Peripheral neuropathy
    8. Diabetes Mellitus
    9. Ischemia of lower limbs
    10. Active infection
    11. Following acute trauma or fracture

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1- Compex® muscle stimulator
Group 1 will receive an active 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 use the stimulator for three 20 minute sessions per day.
Device: Compex® muscle stimulator
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.
Sham Comparator: Group 2 -(inactive) muscle stimulator
Group 2 will receive 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.
Device: (inactive) muscle stimulator
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-operative, 2 weeks, and 6 weeks post-operative

Collaborators and Investigators

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

Sponsor

Orthopedic Foot and Ankle Center, Ohio

Collaborators

DonJoy Orthotics

Investigators

  • Principal Investigator: Christopher Hyer, DPM, MS, Orthopedic Foot and Ankle Center

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 (Actual)

January 1, 2013

Primary Completion (Actual)

September 22, 2016

Study Completion (Actual)

September 22, 2016

Study Registration Dates

First Submitted

April 12, 2013

First Submitted That Met QC Criteria

April 12, 2013

First Posted (Estimate)

April 17, 2013

Study Record Updates

Last Update Posted (Actual)

January 10, 2018

Last Update Submitted That Met QC Criteria

December 12, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OH1-12-00389

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.

Clinical Trials on Achilles Tendon Rupture

Clinical Trials on Compex® muscle stimulator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe