E-Stim and Achilles Tendon Repair Study

Achilles Tendon Rupture Clinical Trial

— E-Stim  

Official title:

The Use of Electrical Stimulation on Muscle Cross Sectional Area and Muscle Fascicle Length Following Postoperative Achilles Tendon Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833936
• Other study ID #: OH1-12-00389
• Status: Completed
• Phase: N/A
• First received: April 12, 2013
• Last updated: December 12, 2017
• Start date: January 2013
• Est. completion date: September 22, 2016

Study information

• Verified date: December 2017
• Source: Orthopedic Foot and Ankle Center, Ohio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 22, 2016
• Est. primary completion date: September 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

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.
• (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.

Locations

Country	Name	City	State
United States	Orthopedic Foot and Ankle Center	Westerville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Orthopedic Foot and Ankle Center, Ohio	DonJoy Orthotics

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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