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ACL ReconstructionNCT07171346

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

A study testing Zynex NexWave Electrotherapy Device in people with ACL Reconstruction and ACL Surgery, run by University of Kansas Medical Center at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 15 to 50 years
Conditions the study is for
ACL Reconstruction, ACL Surgery, ACL Injury
What is being tested?
Zynex NexWave Electrotherapy Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
10 Feb 2026to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Zynex NexWave Electrotherapy Device
Keywords
Electrotherapy, muscle strength, ACLR
Medical subject headings
Anterior Cruciate Ligament Injuries, Muscular Atrophy, Asthenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zynex NexWave Electrotherapy DeviceDevice

    All participants will use the NMES device in addition to standard rehabilitation

Study groups in NCT07171346
Study groupRoleWhat they receive
NMESExperimentalAll participants will use the NMES device in addition to standard rehab protocol
Receives: Device: Zynex NexWave Electrotherapy Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bilateral Muscle Symmetry Index

    Comparing muscle size strength and function between operative and non-operative limbs

    Measured: pre-operative to 3 months post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2025
  2. Study start10 Feb 2026
  3. Primary completionNov 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07171346
Sponsor's protocol ID
STUDY00161884
Status last verified
Mar 2026
First submitted
22 Aug 2025
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 25819154

  • Makihara Y, Nishino A, Fukubayashi T, Kanamori A. Decrease of knee flexion torque in patients with ACL reconstruction: combined analysis of the architecture and function of the knee flexor muscles. Knee Surg Sports Traumatol Arthrosc. 2006 Apr;14(4):310-7. doi: 10.1007/s00167-005-0701-2. Epub 2005 Oct 6.

    PubMed 16208458

  • Konrath JM, Vertullo CJ, Kennedy BA, Bush HS, Barrett RS, Lloyd DG. Morphologic Characteristics and Strength of the Hamstring Muscles Remain Altered at 2 Years After Use of a Hamstring Tendon Graft in Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2016 Oct;44(10):2589-2598. doi: 10.1177/0363546516651441. Epub 2016 Jul 18.

    PubMed 27432052

  • Nomura Y, Kuramochi R, Fukubayashi T. Evaluation of hamstring muscle strength and morphology after anterior cruciate ligament reconstruction. Scand J Med Sci Sports. 2015 Jun;25(3):301-7. doi: 10.1111/sms.12205. Epub 2014 Mar 20.

    PubMed 24646218

  • Currier DP, Ray JM, Nyland J, Rooney JG, Noteboom JT, Kellogg R. Effects of electrical and electromagnetic stimulation after anterior cruciate ligament reconstruction. J Orthop Sports Phys Ther. 1993 Apr;17(4):177-84. doi: 10.2519/jospt.1993.17.4.177.

    PubMed 8467342

  • Heidland A, Fazeli G, Klassen A, Sebekova K, Hennemann H, Bahner U, Di Iorio B. Neuromuscular electrostimulation techniques: historical aspects and current possibilities in treatment of pain and muscle waisting. Clin Nephrol. 2013 Jan;79 Suppl 1:S12-23.

    PubMed 23249528

Questions about this trial

What is this clinical trial studying?

A study testing Zynex NexWave Electrotherapy Device in people with ACL Reconstruction and ACL Surgery, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bilateral Muscle Symmetry Index (time frame: pre-operative to 3 months post-op). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07171346, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.

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