ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01833936
Recruitment Status : Completed
First Posted : April 17, 2013
Results First Posted : January 10, 2018
Last Update Posted : January 10, 2018
Sponsor:
Collaborator:
DonJoy Orthotics
Information provided by (Responsible Party):
Christopher Hyer, Orthopedic Foot and Ankle Center, Ohio

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Achilles Tendon Rupture Device: Compex® muscle stimulator Device: (inactive) muscle stimulator Not Applicable

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  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Use of Electrical Stimulation on Muscle Cross Sectional Area and Muscle Fascicle Length Following Postoperative Achilles Tendon Repair
Actual Study Start Date : January 2013
Actual Primary Completion Date : September 22, 2016
Actual Study Completion Date : September 22, 2016

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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833936


Locations
United States, Ohio
Orthopedic Foot and Ankle Center
Westerville, Ohio, United States, 43082
Sponsors and Collaborators
Orthopedic Foot and Ankle Center, Ohio
DonJoy Orthotics
Investigators
Principal Investigator: Christopher Hyer, DPM, MS Orthopedic Foot and Ankle Center