Electrical Stimulation for ACL Surgery

Overseen By Clinical Research Coordinator/Supervisor - Orthopedic Surgery

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Lower limb injury, Spine surgery, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how adding neuromuscular electrical stimulation, a therapy using electrical pulses to strengthen muscles, to regular rehab aids recovery after ACL surgery. Participants will use the Zynex NexWave Electrotherapy Device alongside standard care to determine if it enhances muscle recovery. Individuals who have undergone ACL surgery at the KUMC sports medicine center and have not experienced other significant leg or spine injuries recently may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve recovery for future patients.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that the Zynex NexWave Electrotherapy Device is safe for ACL surgery recovery?

Research has shown that devices like the Zynex NexWave, which use neuromuscular electrical stimulation (NMES), are generally easy to use and well-tolerated. These devices send small electrical signals to muscles to help improve strength and movement. Users place them on the skin using sticky pads called electrodes.

The sources provided do not specify any serious side effects from using the Zynex NexWave for ACL recovery. However, the device should not be used during pregnancy and is not effective for pain originating from the brain or spinal cord. Overall, NMES devices are considered safe for use in many rehabilitation settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Zynex NexWave Electrotherapy Device because it introduces a non-invasive approach to enhance recovery after ACL surgery. Unlike traditional rehab protocols that rely on physical therapy alone, this device uses neuromuscular electrical stimulation (NMES) to potentially accelerate muscle strengthening and reduce recovery time. By delivering targeted electrical pulses, it aims to improve muscle function more quickly and effectively, offering a promising complement to standard ACL rehabilitation methods.

What evidence suggests that the Zynex NexWave Electrotherapy Device is effective for ACL recovery?

Research has shown that using neuromuscular electrical stimulation (NMES) alongside regular rehab can strengthen muscles after ACL surgery. Studies have found that NMES improves knee movement, which is crucial for recovery. Patients using NMES have reported stronger thigh muscles, potentially speeding up healing. In this trial, all participants will use the Zynex NexWave Electrotherapy Device, a specific NMES device, in addition to the standard rehab protocol. This device effectively aids muscle recovery and prevents muscle wasting, making it a valuable tool for recovery after ACL surgery. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals aged 15-50 with a BMI of 18-30 kg/m2 who are undergoing ACL reconstruction at KUMC sports medicine. Participants should not have had any physical function limitations in the last 6 months, excluding their ACL injury. Those with previous lower limb or spine surgeries, non-English speakers, prisoners, and wards of the state cannot join.

Inclusion Criteria

BMI between 18 - 30 kg/m2

I am an ACLR surgery patient at KUMC sports medicine.

I am between 15 and 50 years old.

Exclusion Criteria

Non-English speaking

Vulnerable population, prisoner, or ward of the state

I have had surgery for an injury to my leg or spine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants undergo pre-operative assessments and begin NMES treatment

Up to surgery date

Post-operative Treatment

Participants use NMES device in addition to standard ACLR rehabilitation

3 months

Follow-up

Participants are monitored for muscle strength and recovery outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Zynex NexWave Electrotherapy Device

Trial Overview The study tests if using the Zynex NexWave Electrotherapy Device along with standard care improves muscle strength recovery after an ACL reconstruction surgery compared to standard care alone.

How Is the Trial Designed?

Group I: NMES Experimental Treatment 1 Intervention

All participants will use the NMES device in addition to standard rehab protocol

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Citations

1. patlynk.com patlynk.com/trial/NCT07171346

Zynex NMES for Post-Operative ACL Rehabilitation This study explores the benefits of using Zynex Neuromuscular Electrical Stimulation (NMES) alongside regular rehabilitation for patients recovering from ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07171346

Study Details | NCT07171346 | Post Operative Use of ... The addition of neuromuscular electrical stimulation (NMES) to standard ACLR rehabilitation has been demonstrated to improve knee extension and flexion compared ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28819679/

Neuromuscular electrical stimulation is effective in ... Neuromuscular electrical stimulation is effective in strengthening the quadriceps muscle after anterior cruciate ligament surgery · Authors · Affiliations.

4. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07171346

Zynex NexWave Electrotherapy Device in Muscle Atrophy or ... In this study we will be comparing bi-lateral presurgical and post surgical muscle strength symmetry in patients that follow the standard ACLR rehabilitation ...

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-019-0566-0

Functional electrical stimulation following anterior cruciate ... The aim of this study was to investigate the feasibility of applying quadriceps functional electrical stimulation (FES) during walking in addition to standard ...

6. zynex.com zynex.com/wp-content/themes/zynex/assets/pdf/nexwave-users-manual.pdf

NexWave User's Manual • The safety of NMES devices for use during pregnancy or birth has not been established. • This device is not effective for pain of central origin. (This ...

7. aetna.com aetna.com/cpb/medical/data/600_699/0677.html

Functional Electrical Stimulation and Neuromuscular ... This Clinical Policy Bulletin addresses functional electrical stimulation and neuromuscular electrical stimulation.

8. digital-assets.wellmark.com digital-assets.wellmark.com/adobe/assets/urn:aaid:aem:6130c61c-a2fd-48c0-905e-880915bf649c/original/as/Functional-Electrical-Stimulation-and-Neuromuscular-Electrical-Stimulation.pdf

Functional-Electrical-Stimulation-and-Neuromuscular- ... Neuromuscular electrical stimulation devices are small electronic devices that are affixed externally to the individual's skin by way of electrodes to provide ...