CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Compex® muscle stimulator +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01833936
NCT01833936N/ACompleted
CompareCT.gov

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

Orthopedic Foot and Ankle Center, Ohio·interventional·Posted Apr 17, 2013·Updated Jan 10, 2018

In Brief

A clinical study evaluating Compex® muscle stimulator and (inactive) muscle stimulator for Achilles Tendon Rupture. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAchilles Tendon Rupture
CountriesUnited States
CollaboratorsDonJoy Orthotics

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 17, 2013
Enrollment StartJan 1, 2013
Primary CompletionSep 22, 2016
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 13.2 years ago

Interventions

Compex® muscle stimulatordevice

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 stimulatordevice

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.