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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment VPOD Wireless Tens Unit for ankle fractures?

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 bone healing in foot and ankle fractures and for reducing pain after surgeries, suggesting it may be beneficial for ankle fractures too. ^{1 2 3 4 5}

Is electrical stimulation safe for treating ankle fractures?

Transcutaneous electrical nerve stimulation (TENS), which is similar to the VPOD Wireless Tens Unit, is generally considered safe for humans. Studies have shown it to be a noninvasive and low-risk method for managing pain in various conditions, with few complications reported. ^{3 6 7 8 9}

How does the VPOD Wireless Tens Unit treatment for ankle fractures differ from other treatments?

The VPOD Wireless Tens Unit is unique because it uses electrical stimulation to help with bone healing and pain reduction, which is different from traditional treatments that may rely on immobilization or surgery alone. This noninvasive approach can be used at home and may enhance bone healing and reduce pain without the need for medication. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a pilot randomized controlled trial, wherein the intervention group will undergo NMES five days a week beginning three weeks postoperative and lasting for ten weeks. Both the control and intervention groups will start standard physical therapy six weeks postoperative. Primary outcome measure will be the isometric strength of the gastrocnemius muscle. The secondary outcomes will comprise subjective clinical evaluations (using the Lower Extremity Functional Scale \[LEFS\]), functional assessments such as the sit-to-stand test, 2-minute walk test, stair climb test and objective clinical evaluation using contralateral comparison of calf circumference.

Research Team

Raymond J. Walls, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

I have had cancer in the past.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Effect of transcutaneous electrical acupoint stimulation on bone loss for patients with foot and ankle fracture: a pragmatic randomized controlled trial. [2022]

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

Transcutaneous electrical nerve stimulation for nonunited fractures; a clinical report. [2019]

3. New Zealand 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. [2022]

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

Healing in the new millennium: bone stimulators: an overview of where we've been and where we may be heading. [2022]

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

Bone growth stimulation for foot and ankle nonunions. [2009]

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

Efficacy of hypothermia and transcutaneous electrical nerve stimulation in podiatric surgery. [2009]

7. England 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). [2022]

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

Multiple rib fractures: transcutaneous nerve stimulation versus conventional analgesia. [2019]

9. England 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. [2019]