E-Stim and Achilles Tendon Repair Study
Completed · Not applicable · Has a placebo group
Conditions studied: Achilles Tendon Rupture
In brief
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.
Key facts
- Study ID
- NCT01833936
- Run by
- Orthopedic Foot and Ankle Center, Ohio
- People needed
- 40
- Starts
- 2013-01-01
- Expected to finish
- 2016-09-22
- Last updated by the study team
- 2018-01-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Body mass index (BMI) greater than or equal to 45
- Inability to consent to participate in clinical research
- Any patient younger than 18 years old
- Any limitations that would interfere with the delivery of electrical stimulation including, but not limited to:
- Presence of an insulin pump
- Pacemaker, defibrillators or other implanted electrical device
- Neurostimulation implants
- History of epilepsy/seizure
- 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.
- Active malignancy
- Peripheral neuropathy
- Diabetes Mellitus
- Ischemia of lower limbs
- Active infection
- Following acute trauma or fracture
Where it is running
- Orthopedic Foot and Ankle Center — Westerville, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.