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Enrolling by invitation NCT07171346

Post Operative Use of Neuromuscular Electrical Stimulation (NMES) Device for ACLR Patients

No phase Interventional ACL Reconstruction ACL Surgery ACL Injury Electrotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zynex NexWave Electrotherapy Device.
Who it may be relevant to
Registry conditions: ACL Reconstruction, ACL Surgery, ACL Injury, Electrotherapy. Basic parameters: 15 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects on Patient Outcomes With Post-Operative Use of Zynex Neuromuscular Electrical Stimulation (NMES): Zynex-25

Overview

This study is being conducted to learn about how neuromuscular electrical stimulation (NMES) in addition to standard of care aids in the recovery of muscle strength in patients undergoing ACLR procedure.

Detailed description

The addition of neuromuscular electrical stimulation (NMES) to standard ACLR rehabilitation has been demonstrated to improve knee extension and flexion compared to standard treatment only. NMES has also shown improved lower limb loading symmetry, walking velocity, stance time, cadence, maximum voluntary isometric contraction, motor unit behavior, muscle quality, and an increase in absolute muscle strength in functional tests compared to standard care of ACLR recovery. In this study we will be comparing bi-lateral presurgical and post surgical muscle strength symmetry in patients that follow the standard ACLR rehabilitation program and patients that use the NMES in addition to standard rehab.

Interventions

  • Device Zynex NexWave Electrotherapy Device
    All participants will use the NMES device in addition to standard rehabilitation

Primary outcome measures

  • Bilateral Muscle Symmetry Index [Time frame: pre-operative to 3 months post-op]

Eligibility criteria

Inclusion criteria

  • ACLR surgical patients at KUMC sports medicine
  • 15 to 50 years old
  • BMI between 18 - 30 kg/m2
  • No limitations impacting physical function within the last 6 months (not including the ACL injury)

Exclusion criteria

  • Previous lower limb or spine injury involving surgical treatment
  • Prior spine surgery
  • Lower limb injury (other than ACL) preventing participation in physical activity for over two weeks in the past 6 months
  • Non english speaking
  • Vulnerable population, prisoner, or ward of the state

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Kansas Medical Center — Kansas City

Publications

  • Melkerson MN. Combination Neuromuscular Electrical Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator, Model NexWave. In: Services DoHH, editor. Silver Spring, MD: Food and Drug Administration; 2011.
  • Labanca L, Rocchi JE, Giannini S, Faloni ER, Montanari G, Mariani PP, Macaluso A. Early Superimposed NMES Training is Effective to Improve Strength and Function Following ACL Reconstruction with Hamstring Graft regardless of Tendon Regeneration. J Sports Sci Med. 2022 Feb 15;21(1):91-103. doi: 10.52082/jssm.2022.91. eCollection 2022 Mar. PMID 35250338
  • Snyder-Mackler L, Delitto A, Bailey SL, Stralka SW. Strength of the quadriceps femoris muscle and functional recovery after reconstruction of the anterior cruciate ligament. A prospective, randomized clinical trial of electrical stimulation. J Bone Joint Surg Am. 1995 Aug;77(8):1166-73. doi: 10.2106/00004623-199508000-00004. PMID 7642660
  • Conley CEW, Mattacola CG, Jochimsen KN, Dressler EV, Lattermann C, Howard JS. A Comparison of Neuromuscular Electrical Stimulation Parameters for Postoperative Quadriceps Strength in Patients After Knee Surgery: A Systematic Review. Sports Health. 2021 Mar;13(2):116-127. doi: 10.1177/1941738120964817. Epub 2021 Jan 11. PMID 33428557
  • Paternostro-Sluga T, Fialka C, Alacamliogliu Y, Saradeth T, Fialka-Moser V. Neuromuscular electrical stimulation after anterior cruciate ligament surgery. Clin Orthop Relat Res. 1999 Nov;(368):166-75. PMID 10613165
  • Jo HD, Kim MK. Effects of neuromuscular electrical stimulation on neuromuscular function and muscle quality in patient following anterior cruciate ligament reconstruction. J Exerc Rehabil. 2025 Apr 30;21(2):79-91. doi: 10.12965/jer.2550086.043. eCollection 2025 Apr. PMID 40351372
  • Snyder-Mackler L, Ladin Z, Schepsis AA, Young JC. Electrical stimulation of the thigh muscles after reconstruction of the anterior cruciate ligament. Effects of electrically elicited contraction of the quadriceps femoris and hamstring muscles on gait and on strength of the thigh muscles. J Bone Joint Surg Am. 1991 Aug;73(7):1025-36. PMID 1874764
  • Lepley LK, Wojtys EM, Palmieri-Smith RM. Combination of eccentric exercise and neuromuscular electrical stimulation to improve quadriceps function post-ACL reconstruction. Knee. 2015 Jun;22(3):270-7. doi: 10.1016/j.knee.2014.11.013. Epub 2014 Dec 10. PMID 25819154

Identifiers

NCT: NCT07171346 · STUDY00161884

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗