NMES + ECC for ACL Injury

(MiACLR Trial)

No longer recruiting at 1 trial location

Overseen By Elizabeth Tropiano

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Previous knee surgery, Knee dislocation, Pregnancy, others

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve muscle function and joint health after surgery for a torn ACL, a major knee ligament. It tests two treatments: neuromuscular electrical stimulation, which uses electric pulses to activate muscles, and eccentric exercise, a specific type of strength training. The goal is to enhance recovery and potentially prevent knee arthritis, a painful joint condition. People with a complete ACL tear who are undergoing surgery at the University of Michigan and are open to follow-up checks might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative recovery methods and improve future treatment options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both Neuromuscular Electrical Stimulation (NMES) and Eccentric Exercise (ECC) are generally well-tolerated, particularly during recovery from ACL surgery, a procedure on a knee ligament. Studies have found that NMES can improve the strength and function of the quadriceps, the large muscle at the front of the thigh, after ACL surgery, making it a popular choice in recovery programs.

Eccentric exercise, which involves slowly lengthening the muscle under tension, is also commonly used in sports recovery. It has been safely used after ACL surgery, and some studies suggest it might provide a better short-term increase in muscle strength compared to other exercises.

While both treatments are usually safe, individual reactions can differ. Prospective trial participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for ACL injuries because they combine neuromuscular electrical stimulation (NMES) and eccentric exercise (ECC) in a unique way. Unlike standard ACL rehabilitation, which typically relies on traditional physical therapy exercises, NMES directly stimulates the quadriceps to enhance muscle strength and recovery. ECC, on the other hand, focuses on lengthening the muscle under tension, which can improve muscle control and prevent future injuries. This combination approach may accelerate recovery and improve outcomes by targeting muscle strength and control more effectively than standard methods alone.

What evidence suggests that NMES and ECC are effective for ACL injury recovery?

This trial will compare the effects of combining Neuromuscular Electrical Stimulation (NMES) and Eccentric Exercise (ECC) with a placebo version of these treatments. Studies have shown that combining electrical muscle stimulation with specific exercises effectively strengthens the thigh muscle, which is crucial after ACL surgery. Research indicates that this approach can restore muscle strength and function to levels similar to those in healthy adults. Electrical stimulation enhances muscle performance, while the exercises boost muscle strength. Together, these methods might improve knee function and potentially prevent future knee issues like arthritis. Evidence suggests that this combination holds promise for better recovery after ACL surgery. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with a complete ACL rupture who are scheduled for ACL reconstruction at the University of Michigan. Participants must be willing to follow the study's procedures and have an autograft procedure. Pregnant women, those planning pregnancy, patients with accompanying bony fractures or knee dislocations, or previous knee surgeries cannot join.

Inclusion Criteria

I had ACL reconstruction using my own tissue.

I am scheduled for ACL reconstruction surgery at the University of Michigan.

I have a completely torn ACL recently.

Exclusion Criteria

I have a broken bone along with an ACL injury.

I have had a knee dislocation.

I have had surgery on one or both of my knees.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NMES or NMES placebo for 8 weeks followed by eccentric exercise or placebo for another 8 weeks, alongside standard ACL rehabilitation

16 weeks

2 visits per week (in-person)

Follow-up

Participants are monitored for muscle strength and cartilage health at 6 and 18 months post-ACL reconstruction

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Eccentric Exercise (ECC)
• Eccentric Exercise (ECC) placebo
• Neuromuscular Electrical Stimulation (NMES)
• Neuromuscular Electrical Stimulation (NMES) placebo

Trial Overview The MiACLR trial is testing whether Neuromuscular Electrical Stimulation (NMES) and Eccentric Exercise (ECC), along with their placebos, can improve muscle function and cartilage health after ACL surgery to prevent post-traumatic knee osteoarthritis.

How Is the Trial Designed?

Group I: NMES+ECC Experimental Treatment 2 Interventions

Neuromuscular electrical stimulation (NMES) and Eccentric Exercise (ECC). Patients randomized to the NMES+ECC group will first receive NMES for 2x/week for 8 weeks, beginning at the first post-operative visit. Beginning at 9 weeks after anterior cruciate ligament reconstruction (ACLR) patients will begin to receive eccentric exercise 2x/week for an additional 8 weeks. For NMES, patients will have electrical stimulation delivered to their quadriceps. Fifteen isometric actions lasting 10 seconds each will be elicited during each session. For eccentric exercise, patients will train for 4 sets of 10 repetitions. This group will also receive standard of care ACL rehabilitation alongside the study interventions.

Group II: NMES placebo + ECC placebo Placebo Group 2 Interventions

Neuromuscular electrical stimulation (NMES) low intensity/placebo + Eccentric Exercise (ECC) low intensity/placebo arm. Patients randomized to the NMES low intesntiy/placebo + ECC low intensity/placebo group will first receive NMES placebo/low-intensity treatment for 2x/week for 8 weeks, beginning at the first post-operative physical therapy visit. Beginning at 9 weeks after anterior cruciate ligament reconstruction (ACLR) patients will begin to receive an eccentric exercise low-intensity/placebo 2x/week for 8 weeks. For the NMES low intensity/placebo, patients will have it delivered to their quadriceps 2x/week for 8 weeks beginning at the first post-operative visit. Fifteen isometric actions lasting 10 seconds each will be elicited during each session. For the eccentric exercise low-intensity/placebo, patients will begin to receive eccentric exercise two times per week for 8 weeks. Patients will train for 4 sets of 10 repetitions.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

University of Delaware

Collaborator

Trials

167

Recruited

25,700+

University of Connecticut

Collaborator

Trials

194

Recruited

162,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25819154/

Combination of eccentric exercise and ... - PubMed Eccentric exercise was capable of restoring levels of quadriceps activation and strength that were similar to those of healthy adults and better than NMES ...

2. jospt.org jospt.org/doi/10.2519/jospt.2010.3184

Effects of Neuromuscular Electrical Stimulation After ... Neuromuscular electrical stimulation is effective in strengthening the quadriceps muscle after anterior cruciate ligament surgery. 17 August 2017 | Knee ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0968016014002816

Combination of eccentric exercise and neuromuscular ... Eccentric exercise post-ACL reconstruction was found to positively improve quadriceps activation and strength.

4. e-jer.org e-jer.org/journal/view.php?number=2013601070

Effects of neuromuscular electrical stimulation on ... This study investigated the effects of NMES on neuromuscular function and muscle quality in individuals with ACLR who could walk normally.

5. thekneejournal.com thekneejournal.com/article/S0968-0160(14)00281-6/references

Combination of eccentric exercise and neuromuscular ... Neuromuscular electrical stimulation (NMES) has been shown to reduce quadriceps activation failure (QAF), and eccentric exercise has been shown to lessen ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3105370/

TENDINOPATHY, HAMSTRING STRAINS, AND ACL ... Eccentric exercise offers promise as an effective means to manage a host of common conditions encountered by the sports rehabilitation specialist.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2214687323000249

Effect of eccentric isokinetic exercise on muscle strength ... Previous studies have shown isokinetic exercise forms an important part in reconditioning the patients after anterior cruciate ligament reconstruction (ACLR) in ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17286094/

Safety, Feasibility, and Efficacy of Negative Work Exercise ... Conclusions: Negative work via an ECC intervention was implemented safely after ACL-R. The addition of negative work exercise also induced superior short-term ...

9. physio-pedia.com physio-pedia.com/Anterior_Cruciate_Ligament_(ACL)_Rehabilitation

Anterior Cruciate Ligament (ACL) Rehabilitation The ACL rehabilitation is both for conservative and surgical options. Conservative treatment of an ACL injury could be the best choice for sedentary patients.

10. btetechnologies.com btetechnologies.com/therapyspark/ultimate-guide-eccentric-training/

PT's Ultimate Eccentric Training Guide: ACL, Fall Prevention ... One study on ACL rehabilitation techniques showed a 30% strength increase with eccentric exercise, compared to concentric alone.13 The research suggests that ...