← Back to Search

Neuromuscular Electrical Stimulation

Electrical Stimulation for Ruptured Achilles Tendon

N/A
Recruiting
Research Sponsored by Penn State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Achilles tendon rupture
Be older than 18 years old
Must not have
Those unable to understand spoken English
Tendon ruptures associated with the use of fluoroquinolones (Examples include ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin))
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, 6, 12
Awards & highlights

Summary

This trial will test a new rehabilitation protocol using electrical stimulation to improve outcomes for patients who have ruptured their Achilles tendon.

Who is the study for?
This trial is for individuals who have experienced an Achilles tendon rupture and are undergoing recovery. It's not suitable for those who can't understand English, were treated non-operatively, had ruptures related to fluoroquinolone antibiotics use, or have conditions like diabetes or poor leg circulation that affect healing. People with augmented surgical repairs or allergies to ultrasound gel aren't eligible either.Check my eligibility
What is being tested?
The study is testing a new rehab method using Neuromuscular Electrical Stimulation (NMES) on patients with Achilles tendon ruptures. The aim is to see if NMES helps reduce muscle loss and improve the quality of the repaired tendon compared to standard care.See study design
What are the potential side effects?
While NMES is generally safe, potential side effects may include discomfort at the stimulation site, skin irritation from electrode placement, muscle fatigue after treatment sessions, and in rare cases mild pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a ruptured Achilles tendon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot understand spoken English.
Select...
I have had tendon ruptures from taking certain antibiotics.
Select...
I am being treated without surgery.
Select...
My surgery involved adding extra tissue at the repair site.
Select...
I am unable to give consent by myself.
Select...
I do not have diabetes or heart conditions that affect my legs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, 6, 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1, 6, 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ability to perform a single heel rise
Secondary outcome measures
Achilles Total Rupture Score
Foot and Ankle Outcome Score (FAOS)
Gastrocnemius muscle cross-sectional area
+4 more

Trial Design

2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Patients will follow standard therapy for Achilles tendon repair.
Group II: Neuromuscular Electrical StimulationActive Control1 Intervention
Neuromuscular electrical stimulation will be applied to the calf muscles. The level of stimulation will be increased weekly from 10 to 30 mA during the first 6 weeks after surgery. In addition, patients will follow standard therapy for Achilles tendon repair.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for ruptured Achilles tendon include surgical repair, physical therapy, and Neuromuscular Electrical Stimulation (NMES). Surgical repair involves stitching the torn ends of the tendon together to restore its integrity. Physical therapy focuses on exercises to strengthen the surrounding muscles and improve flexibility. NMES uses electrical impulses to stimulate muscle contractions, which helps reduce muscle atrophy and improve tendon properties by promoting blood flow and enhancing the healing process. These mechanisms are crucial for patients as they aim to restore function, reduce recovery time, and prevent long-term deficits in the affected leg.
Comparison of the Effects of Pulsed Electromagnetic Field and Extracorporeal Shockwave Therapy in a Rabbit Model of Experimentally Induced Achilles Tendon Injury.Paradigms of Lower Extremity Electrical Stimulation Training After Spinal Cord Injury.Tendinosis-like histologic and molecular changes of the Achilles tendon to repetitive stress: a pilot study in rats.

Find a Location

Who is running the clinical trial?

Penn State UniversityLead Sponsor
359 Previous Clinical Trials
125,897 Total Patients Enrolled

Media Library

NMES (Neuromuscular Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04727047 — N/A
Ruptured Achilles Tendon Research Study Groups: Control, Neuromuscular Electrical Stimulation
Ruptured Achilles Tendon Clinical Trial 2023: NMES Highlights & Side Effects. Trial Name: NCT04727047 — N/A
NMES (Neuromuscular Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04727047 — N/A
~11 spots leftby Dec 2024