Electrical Stimulation for Ankle Fractures

Overseen By Raymond J. Walls, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Corticosteroids

Disqualifiers: Rheumatoid arthritis, Cancer, Neurological disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how electrical stimulation can aid in regaining strength after an ankle fracture. Participants will use the VPOD Wireless Tens Unit, a wireless device that delivers electrical impulses to muscles, in conjunction with regular physical therapy. The primary goal is to determine if this method enhances muscle strength and overall leg function compared to standard therapy alone. Individuals who have recently undergone surgery for an ankle fracture and are willing to participate may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve recovery methods for future 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 you are using chronic corticosteroids, you may not be eligible to participate.

What prior data suggests that this electrical stimulation technique is safe for ankle fracture recovery?

Research has shown that transcutaneous electrical nerve stimulation (TENS), such as the VPOD Wireless Tens Unit, is generally safe. Studies have found that this type of electrical stimulation is well tolerated. In a previous study with individuals recovering from ankle injuries, neuromuscular electrical stimulation (NMES) was well accepted and significantly aided recovery. The VPOD device uses low-voltage electrical currents to relieve pain and discomfort by sending gentle impulses through pads placed on the skin. Users have not reported any major safety concerns, making it a promising option for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VPOD Wireless Tens Unit for ankle fractures because it uses neuromuscular electrical stimulation (NMES) to potentially speed up recovery. Unlike standard physical therapy, which typically begins six weeks after surgery, this treatment starts electrical stimulation just three weeks post-surgery and continues for ten weeks. This approach might enhance muscle function and promote healing earlier than traditional methods, offering a new way to support recovery.

What evidence suggests that the VPOD Wireless Tens Unit is effective for ankle fractures?

Research shows that electrical stimulation, such as the VPOD Wireless Tens Unit, can aid bone healing and reduce pain. Studies have found it effective for enhancing recovery after ankle injuries. In this trial, participants in the intervention group will use neuromuscular electrical stimulation (NMES) with the VPOD Wireless Tens Unit. Previous studies have shown that this approach significantly improves strength and movement after an ankle sprain. This treatment strengthens muscles and improves balance, which is crucial for healing after fractures. Overall, promising evidence suggests that NMES could help people recover better and faster from ankle fractures. ^{1 2 3 4 6}

Who Is on the Research Team?

Raymond J. Walls, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals recovering from ankle fractures. Participants should be starting their recovery and will be split into two groups: one receiving neuromuscular electrical stimulation (NMES) along with standard physical therapy, and the other just standard physical therapy.

Inclusion Criteria

I am able and willing to agree to the study's procedures.

I am having surgery to fix a broken ankle.

Exclusion Criteria

History of connective tissue disorders

History of implanted electrical devices

History of abdominal hernia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Postoperative Recovery

Participants recover from foot and ankle surgery before starting interventions

3 weeks

Treatment

Intervention group undergoes NMES five days a week for ten weeks; both groups start standard physical therapy at six weeks postoperative

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments like LEFS, sit-to-stand test, and stair climb test

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VPOD Wireless Tens Unit

Trial Overview The study tests if NMES can improve muscle strength in the calf after an ankle fracture when started three weeks post-surgery. It's a pilot study where participants are randomly chosen to receive either NMES or no NMES, alongside regular physical therapy.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 3 Interventions

Participants randomized to the intervention group will undergo neuromuscular electrical stimulation (NMES) five days a week beginning three weeks postoperative and lasting for ten weeks. The intervention group will begin standard physical therapy at six weeks postoperative.

Group II: Control Group Active Control 2 Interventions

Participants randomized to the control group will begin standard physical therapy at six weeks postoperative.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

In a study involving 70 male athletes recovering from ACL reconstruction, adding transcutaneous electrical nerve stimulation (TENS) to a rehabilitation exercise program did not provide any additional benefits in pain relief or knee function compared to exercise alone.

Both groups showed improvements in pain and knee function over time, but the results indicate that TENS is not an effective enhancement to the rehabilitation process during the first four weeks post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding high-frequency transcutaneous electrical nerve stimulation to the first phase of post anterior cruciate ligament reconstruction rehabilitation does not improve pain and function in young male athletes more than exercise alone: a randomized single-blind clinical trial. Forogh, B., Aslanpour, H., Fallah, E., et al.[2019]

In a study of 41 patients recovering from hip fracture surgery, the use of active TENS significantly reduced pain during walking compared to sham TENS, indicating its efficacy in managing acute postoperative pain.

Active TENS also improved walking distance and mobility on the fifth day post-surgery, suggesting it can enhance functional recovery when added to standard rehabilitation care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous electrical nerve stimulation (TENS) on acute postoperative pain intensity and mobility after hip fracture: A double-blinded, randomized trial. Elboim-Gabyzon, M., Andrawus Najjar, S., Shtarker, H.[2022]

Transcutaneous electrical nerve stimulation (TENS) significantly reduces pain intensity during or immediately after treatment compared to placebo, based on a systematic review of 381 randomized controlled trials involving over 24,500 participants.

TENS also shows lower pain intensity compared to standard pharmacological and non-pharmacological treatments, with moderate-certainty evidence indicating it is effective and generally safe, as adverse events were mild and similar to those of comparators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study). Johnson, MI., Paley, CA., Jones, G., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06370325?term=AREA%5BConditionSearch%5D(%22Ankle%20Fractures%22)&rank=5

Neuromuscular Electrical Stimulation in Foot and Ankle ... Primary outcome measure will be the isometric strength of the gastrocnemius muscle. The secondary outcomes will comprise subjective clinical evaluations (using ...

2. withpower.com withpower.com/trial/phase-ankle-fractures-3-2024-78967

Electrical Stimulation for Ankle Fractures · Info for Participants Research shows that electrical stimulation, like the VPOD Wireless Tens Unit, can help with bone healing and reduce pain. Studies have found it effective for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6535900/

Does Neuromuscular Electrical Stimulation Improve Recovery ... In this pilot, randomised controlled trial, NMES was well tolerated by patients following ankle sprain and demonstrated statistically significant improvements ...

4. smartpatients.com smartpatients.com/trials/NCT06370325

Neuromuscular Electrical Stimulation in Foot and Ankle ... This is a pilot randomized controlled trial, wherein the intervention group will undergo NMES five days a week beginning three weeks postoperative and lasting ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36634453/

The effects of neuromuscular electrical stimulation to ... Main outcome measures: Participants were assessed for reflexive and corticospinal excitability to the ankle muscles, dynamic balance, side-hop test performance ...

6. amazon.com amazon.com/Wireless-Tens-Unit-TUW20-Electrotherapy/dp/B0842BWJ7W

Massage Therapy Concepts VPOD Wireless TENS Unit The VPOD TENS and EMS Unit uses low-voltage electrical currents to relieve aches and pains, sending impulses through electrodes on the skin, reducing discomfort ...