E-Stim and Achilles Tendon Repair Study

Orthopedic Foot & Ankle Center

Status: Completed

Conditions: Achilles Tendon Rupture

Treatments: Device: (inactive) muscle stimulator; Device: Compex® muscle stimulator

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01833936

OH1-12-00389

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups

Group 1- Compex® muscle stimulator

Active Comparator group

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.

Treatment:

Device: Compex® muscle stimulator

Group 2 -(inactive) muscle stimulator

Sham Comparator group

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.

Treatment:

Device: (inactive) muscle stimulator