Clinical trial NCT01833936: E-Stim and Achilles Tendon Repair Study
Official title: The Use of Electrical Stimulation on Muscle Cross Sectional Area and Muscle Fascicle Length Following Postoperative Achilles Tendon Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendon Rupture
Keywords: Achilles
Lead sponsor: Orthopedic Foot and Ankle Center, Ohio
Sponsor class: OTHER
Collaborators: name: DonJoy Orthotics
First posted: 2013-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

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

Primary outcomes:
measure: Reduce Calf Muscle Atrophy
timeFrame: Pre-operative, 2 weeks, and 6 weeks post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Westerville
country: United States
facility: Orthopedic Foot and Ankle Center
state: Ohio
Study officials:
affiliation: Orthopedic Foot and Ankle Center
name: Christopher Hyer, DPM, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.