What side effects are associated with this type of intervention?

Neuromuscular Electrical Stimulation (NMES) for treating a ruptured Achilles tendon is generally considered safe, but mild side effects can occur. These may include skin irritation or redness at the site of electrode placement, muscle soreness, and discomfort during the stimulation. Serious adverse events are rare. Patients should discuss any concerns with their healthcare provider to ensure the treatment is appropriate for their specific condition.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for ruptured Achilles tendon that are exactly like Neuromuscular Electrical Stimulation (NMES) in the provided context. However, NMES is being studied as a potential rehabilitation protocol to reduce muscle atrophy and improve tendon properties in patients with Achilles tendon rupture. This suggests that while NMES may not yet be FDA-approved specifically for this indication, it is under investigation and could be considered a promising approach in the future.

What other types of research exist?

Promising novel alternatives to NMES for treating ruptured Achilles tendon patients include: 1) Platelet-Rich Plasma (PRP) therapy, which uses concentrated platelets to promote healing and reduce inflammation; 2) Stem cell therapy, which involves injecting stem cells to regenerate damaged tissues; 3) Extracorporeal Shock Wave Therapy (ESWT), which uses shock waves to stimulate healing and reduce pain; and 4) Advanced physical therapy techniques, such as eccentric loading exercises, which have been shown to improve tendon healing and strength.

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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

No Placebo-Only Group

Summary

This trial is testing NMES, a technique that uses electrical impulses to strengthen muscles, on patients with Achilles tendon ruptures. These patients often have long-term issues like weak calf muscles. NMES helps by making the muscles work, which supports better tendon healing. Neuromuscular electrical stimulation (NMES) has been used to improve muscle strength and activation in various conditions, including knee osteoarthritis, spinal cord injury, and muscle wasting in heart failure patients.

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.

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.

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

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I have a ruptured Achilles tendon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot understand spoken English.

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I have had tendon ruptures from taking certain antibiotics.

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I am being treated without surgery.

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My surgery involved adding extra tissue at the repair site.

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I am unable to give consent by myself.

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I do not have diabetes or heart conditions that affect my legs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1, 6, 12

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ability to perform a single heel rise

Secondary study objectives

Achilles Total Rupture Score

Foot and Ankle Outcome Score (FAOS)

Gastrocnemius muscle cross-sectional area

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met

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.