E-Stim and Achilles Tendon Repair Study

Not Applicable

Completed

• Conditions: Achilles Tendon Rupture
• Interventions: Device: Compex® muscle stimulator; Device: (inactive) muscle stimulator

• Registration Number: NCT01833936
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-04-12
• Study First Submitted QC: 2013-04-12
• Study First Posted: 2013-04-17
• Primary Completion: 2016-09-22
• Study Completion: 2016-09-22
• Results First Submitted: 2017-10-30
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-12
• Last Update Submitted: 2017-12-12
• Results First Posted: 2018-01-10
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1- Compex® muscle stimulator	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.
Group 2 -(inactive) muscle stimulator	(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.

Primary Outcome Measures

Name	Time	Method
Reduce Calf Muscle Atrophy	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.

Trial Locations

Locations (1)

Orthopedic Foot and Ankle Center; 🇺🇸 Westerville, Ohio, United States