Electrical Stimulation for Ruptured Achilles Tendon

Recruiting in State College (>99 mi)

+1 other 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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment NMES (Neuromuscular Electrical Stimulation) for ruptured Achilles tendon?

The research does not directly address the effectiveness of NMES for ruptured Achilles tendons, but early muscle stimulation is mentioned as part of a surgical technique for Achilles tendon ruptures, suggesting potential benefits in functional recovery. ^{1 2 3 4 5}

Is neuromuscular electrical stimulation (NMES) safe for humans?

Research shows that NMES is generally safe for humans, as studies have not reported significant safety concerns. However, some discomfort may occur, and electrode size and placement can affect comfort levels. ^{6 7 8 9 10}

How does NMES treatment differ from other treatments for ruptured Achilles tendon?

NMES (Neuromuscular Electrical Stimulation) is unique because it uses electrical impulses to stimulate muscle contractions, which can aid in muscle recovery and strength without the need for surgery. This approach is different from traditional treatments that often involve surgical repair or immobilization, as it focuses on enhancing muscle function and potentially speeding up rehabilitation. ^{1 2 5 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

EMG monitoring during functional non-surgical therapy of Achilles tendon rupture. [2017]

2. France pubmed.ncbi.nlm.nih.gov

[Surgical treatment of ruptures of the Achilles tendon. Apropos of 42 cases treated by Bosworth's technique]. [2006]

3. Germany pubmed.ncbi.nlm.nih.gov

Motor performance of the foot after Achilles rupture repair. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Acute Achilles tendon rupture: Skip the surgery? [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Current Consensus for Rehabilitation Protocols of the Surgically Repaired Acute Mid-Substance Achilles Rupture: A Systematic Review and Recommendations From the "GAIT" Study Group. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Does Functional Neuromuscular Electrical Stimulation (NMES) Influence Calf Atrophy Following Achilles Tendon Surgery? Prospective Double-Blind Randomized Controlled Trial on the Use of Immediate Postoperative Electrical Muscle Stimulation to Preserve Muscle Function and Volume. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effects of electrode size and placement on comfort and efficiency during low-intensity neuromuscular electrical stimulation of quadriceps, hamstrings and gluteal muscles. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation for Venous Thromboembolism Prophylaxis and Its Effects on Somatosensory-Evoked Potentials: A Pretrial Study of a New, U.S. Food and Drug Administration-Approved Device. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Comparison of maximum tolerated muscle torques produced by 2 pulse durations. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

The effect of neuromuscular electrical stimulation on quadriceps strength and knee function in professional soccer players: return to sport after ACL reconstruction. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Complete Achilles tendon ruptures. [2005]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Neuromechanical Modulation of the Achilles Tendon During Bilateral Hopping in Patients with Unilateral Achilles Tendon Rupture, Over 1 Year After Surgical Repair. [2018]