Electrical Stimulation for Ruptured Achilles Tendon

No longer recruiting at 1 trial location

Overseen By Andrea Myers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Must not be taking: Fluoroquinolones

Disqualifiers: Non-English speakers, Non-operative treatment, Augmented repair, Allergy to gel, Walking impairment, Diabetes, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new rehabilitation method for individuals with a torn Achilles tendon using Neuromuscular Electrical Stimulation (NMES), which sends electrical pulses to muscles. The researchers aim to determine if NMES can reduce muscle loss and improve tendon healing compared to the usual recovery process. Participants will receive either standard therapy or standard therapy plus NMES, with the stimulation level gradually increasing over six weeks. This trial suits those who had surgery for an Achilles tendon rupture but excludes those whose tendon tear was treated without surgery, involved extra tissue during repair, or was linked to certain antibiotics. As an unphased trial, this study provides a unique opportunity to explore innovative rehabilitation techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if your tendon rupture is associated with the use of fluoroquinolones (a type of antibiotic), you would be excluded from participating.

What prior data suggests that this rehabilitation protocol using NMES is safe for Achilles tendon rupture?

Research has shown that Neuromuscular Electrical Stimulation (NMES) is generally well-tolerated. In past studies on NMES for various health issues, such as Achilles tendon problems, most participants did not experience serious side effects. The treatment sends small electrical pulses to muscles, aiding in contraction and strengthening.

Some participants have reported mild side effects, like skin irritation at electrode sites, but these are uncommon. Since NMES is already used for other health conditions, it appears to be quite safe. However, discussing potential risks with a healthcare provider before joining a trial is essential. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Neuromuscular Electrical Stimulation (NMES) for Achilles tendon repair because it offers a unique approach to rehabilitation. Unlike traditional treatments, which typically involve rest, physical therapy, and sometimes surgery, NMES directly stimulates the calf muscles with electrical impulses. This technique could enhance muscle strength and recovery speed by actively engaging the muscles during the healing process. By potentially accelerating recovery and improving muscle function, NMES represents a promising advancement in treating ruptured Achilles tendons.

What evidence suggests that this protocol is effective for Achilles tendon rupture?

Research has shown that Neuromuscular Electrical Stimulation (NMES), which participants in this trial may receive, can aid muscle recovery after an Achilles tendon rupture. NMES uses electrical signals to strengthen muscles, potentially preventing muscle wasting and improving tendon healing. One study found that NMES helped regain muscle strength more effectively than standard therapy alone. This is important because many patients struggle to fully recover strength after an Achilles injury. Early results suggest that NMES may support better long-term function in the injured leg. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have a ruptured Achilles tendon.

Exclusion Criteria

I cannot understand spoken English.

I have had tendon ruptures from taking certain antibiotics.

Allergy to ultrasound gel

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Neuromuscular Electrical Stimulation (NMES) is applied to the calf muscles, with stimulation levels increased weekly from 10 to 30 mA during the first 6 weeks after surgery

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of heel rise ability, tendon length, and muscle cross-sectional area

6 weeks

Long-term Follow-up

Participants are further monitored for long-term outcomes such as tendon and muscle measurements and functional scores

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NMES

Trial Overview 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.

How Is the Trial Designed?

Group I: Control Active Control 1 Intervention

Patients will follow standard therapy for Achilles tendon repair.

Group II: Neuromuscular Electrical Stimulation Active Control 1 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.

NMES is already approved in United States, European Union for the following indications:

Approved in United States as Neuromuscular Electrical Stimulation for:

• Muscle wasting and weakness after subarachnoid hemorrhage (SAH)
• Rehabilitation post-SAH

Approved in European Union as Neuromuscular Electrical Stimulation for:

• Muscle weakness and wasting in critically ill patients
• Rehabilitation post-SAH

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Published Research Related to This Trial

In a study involving 10 adults, neuromuscular electrical stimulation (NMES) with a 200-microsecond pulse duration allowed participants to tolerate significantly greater muscle torques compared to a 50-microsecond pulse duration, indicating enhanced efficacy for muscle strengthening.

The findings suggest that medium pulse durations may be more effective for maximizing muscle torque responses, despite the common belief that shorter pulses are preferable due to lower pain thresholds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of maximum tolerated muscle torques produced by 2 pulse durations. Scott, WB., Causey, JB., Marshall, TL.[2014]

Citations

1. jospt.org jospt.org/doi/10.2519/jospt.2025.13151

Neuromuscular Electrical Stimulation for Tendon Loading Most participants were healthy (60%), whereas others had patellar tendinopathy (20%), spinal cord injury (10%), or Achilles tendon rupture (10%) ...

2. etda.libraries.psu.edu etda.libraries.psu.edu/catalog/21653spr5679

NMES Rehab Protocol for Achilles Tendon Rupture Recovery from an Achilles tendon rupture (ATR), whether treated conservatively or surgically, can take up to a year, with many patients failing to regain pre- ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01833936?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22DonJoy%20Orthotics%22)&viewType=Table&rank=1

NCT01833936 | E-Stim and Achilles Tendon Repair Study The purpose of this study is to determine if the use of neuromuscular electrical stimulation (NMES) after Achilles tendon surgery will reduce calf muscle ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11898158/

Muscle Contraction Is Essential for Tendon Healing and ... Incomplete tendon healing and postponed muscle weakness after Achilles tendon rupture and surgical repair lead to poor performance in patient activities.

5. withpower.com withpower.com/trial/phase-rupture-4-2021-99cd4

Electrical Stimulation for Ruptured Achilles Tendon This trial is testing NMES, a technique that uses electrical impulses to strengthen muscles, on patients with Achilles tendon ruptures.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04727047

NCT04727047 | NMES for Achilles Tendon Rupture The objective of this study is to develop a neuromuscular electrical stimulation (NMES) rehabilitation protocol for Achilles tendon ruptures. Our preliminary ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40589239/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=0Oqr798sG9mliJMwEZpTfThl3ttUsvqIRGpWUgYffNX&fc=None&ff=20251026004452&v=2.18.0.post22+67771e2

Neuromuscular Electrical Stimulation for Patellar and ... Most participants were healthy (60%), whereas others had patellar tendinopathy (20%), spinal cord injury (10%), or Achilles tendon rupture (10%) ...

8. jfas.org jfas.org/article/S1067-2516(21)00001-6/abstract

Does Functional Neuromuscular Electrical Stimulation ... Surgical repair of the Achilles tendon can lead to prolonged calf atrophy and functional limitations, even with early weightbearing.