Completed

E-StimElectrical Stimulation for Muscle Recovery After Achilles Tendon Surgery

Study Aim

This study aims to prevent muscle atrophy after Achilles tendon surgery by using electrical stimulation, with the primary outcome being the reduction in calf muscle loss measured through MRI scans.

What is being tested

Using Compex® for Muscle Stimulation

+ Inactive Muscle Stimulator Use

Device

Who is being recruted

Over 18 Years

See all eligibility criteria

How is the trial designed

Prevention Study

Placebo-Controlled

Interventional

Study Start: January 2013

See protocol details

Summary

Principal SponsorOrthopedic Foot and Ankle Center, Ohio

Last updated: January 10, 2018

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01833936

Principal SponsorOrthopedic Foot and Ankle Center, Ohio

Last updated: January 10, 2018

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

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.

Group II

Sham

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Orthopedic Foot and Ankle Center

Westerville, United StatesOpen Orthopedic Foot and Ankle Center in Google Maps

CompletedOne Study Center