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

Primary Purpose

Achilles Tendon Rupture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compex® muscle stimulator
(inactive) muscle stimulator
Sponsored by
Orthopedic Foot and Ankle Center, Ohio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Achilles Tendon Rupture focused on measuring Achilles

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthopedic Foot and Ankle Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Group 1- Compex® muscle stimulator

Group 2 -(inactive) muscle stimulator

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Reduce Calf Muscle Atrophy
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.

Secondary Outcome Measures

Full Information

First Posted
April 12, 2013
Last Updated
December 12, 2017
Sponsor
Orthopedic Foot and Ankle Center, Ohio
Collaborators
DonJoy Orthotics
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1. Study Identification

Unique Protocol Identification Number
NCT01833936
Brief Title
E-Stim and Achilles Tendon Repair Study
Acronym
E-Stim
Official Title
The Use of Electrical Stimulation on Muscle Cross Sectional Area and Muscle Fascicle Length Following Postoperative Achilles Tendon Repair
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
September 22, 2016 (Actual)
Study Completion Date
September 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orthopedic Foot and Ankle Center, Ohio
Collaborators
DonJoy Orthotics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture
Keywords
Achilles

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1- Compex® muscle stimulator
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2 -(inactive) muscle stimulator
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Compex® muscle stimulator
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
(inactive) muscle stimulator
Intervention Description
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 Measure Information:
Title
Reduce Calf Muscle Atrophy
Description
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.
Time Frame
Pre-operative, 2 weeks, and 6 weeks post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Hyer, DPM, MS
Organizational Affiliation
Orthopedic Foot and Ankle Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedic Foot and Ankle Center
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43082
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17331181
Citation
Gomes AR, Cornachione A, Salvini TF, Mattiello-Sverzut AC. Morphological effects of two protocols of passive stretch over the immobilized rat soleus muscle. J Anat. 2007 Mar;210(3):328-35. doi: 10.1111/j.1469-7580.2007.00697.x.
Results Reference
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PubMed Identifier
20688546
Citation
Gorodetskyi IG, Gorodnichenko AI, Tursin PS, Reshetnyak VK, Uskov ON. Use of noninvasive interactive neurostimulation to improve short-term recovery in patients with surgically repaired bimalleolar ankle fractures: a prospective, randomized clinical trial. J Foot Ankle Surg. 2010 Sep-Oct;49(5):432-7. doi: 10.1053/j.jfas.2010.05.007. Epub 2010 Aug 5.
Results Reference
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PubMed Identifier
21502118
Citation
Lieber RL, Ward SR. Skeletal muscle design to meet functional demands. Philos Trans R Soc Lond B Biol Sci. 2011 May 27;366(1570):1466-76. doi: 10.1098/rstb.2010.0316.
Results Reference
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PubMed Identifier
20453461
Citation
Takano Y, Haneda Y, Maeda T, Sakai Y, Matsuse H, Kawaguchi T, Tagawa Y, Shiba N. Increasing muscle strength and mass of thigh in elderly people with the hybrid-training method of electrical stimulation and volitional contraction. Tohoku J Exp Med. 2010 May;221(1):77-85. doi: 10.1620/tjem.221.77.
Results Reference
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E-Stim and Achilles Tendon Repair Study

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