NCT01833936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 10, 2018

Completed
Last Updated

January 10, 2018

Status Verified

December 1, 2017

Enrollment Period

3.7 years

First QC Date

April 12, 2013

Results QC Date

October 30, 2017

Last Update Submit

December 12, 2017

Conditions

Achilles Tendon Rupture

Keywords

Achilles

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pre-operative, 2 weeks, and 6 weeks post-operative

Study Arms (2)

Group 1- Compex® muscle stimulator

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.

Device: Compex® muscle stimulator

Group 2 -(inactive) muscle stimulator

SHAM COMPARATOR

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

Interventions

Compex® muscle stimulatorDEVICE

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.

Group 1- Compex® muscle stimulator
(inactive) muscle stimulatorDEVICE

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.

Group 2 -(inactive) muscle stimulator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedic Foot and Ankle Center

Westerville, Ohio, 43082, United States

Location

Related Publications (4)

  • 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.

    PMID: 17331181BACKGROUND

  • 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.

    PMID: 20688546BACKGROUND

  • 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.

    PMID: 21502118BACKGROUND

  • 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.

    PMID: 20453461BACKGROUND

Results Point of Contact

Title
Dr. Christopher Hyer
Organization
Orthopedic Foot and Ankle Center
ofacresearch@orthofootankle.com
6148958747

Study Officials

  • Christopher Hyer, DPM, MS

    Orthopedic Foot and Ankle Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DPM, MS

Study Record Dates

First Submitted

April 12, 2013

First Posted

April 17, 2013

Study Start

January 1, 2013

Primary Completion

September 22, 2016

Study Completion

September 22, 2016

Last Updated

January 10, 2018

Results First Posted

January 10, 2018

Record last verified: 2017-12

Locations

US(1)