NCT01833936

E-Stim and Achilles Tendon Repair Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Orthopedic Foot and Ankle Center, Ohio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Achilles Tendon Rupture

Interventions

Type	Name	Description
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.
DEVICE	(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.

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-09-22
• Completion: 2016-09-22
• First posted: 2013-04-17
• Last updated: 2018-01-10
• Results posted: 2018-01-10

Locations

1 site across 1 country: United States