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

NCT ID: NCT07171346

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2028-06-30

Brief Summary

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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

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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.

Conditions

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ACL Reconstruction ACL Surgery ACL Injury Electrotherapy Muscle Atrophy or Weakness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NMES

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

Group Type EXPERIMENTAL

Zynex NexWave Electrotherapy Device

Intervention Type DEVICE

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

Interventions

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Zynex NexWave Electrotherapy Device

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Scott Mullen

Associate Professor Orthopedic Surgery & Sports Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Central Contacts

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Clinical Research Coordinator/Supervisor - Orthopedic Surgery

Role: CONTACT

913-945-6289

Facility Contacts

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Clinical Research Coordinator/Supervisor - Orthopedic Surgery

Role: primary

913-945-6289

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 35250338 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7642660 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33428557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10613165 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 40351372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1874764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25819154 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16208458 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27432052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24646218 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8467342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23249528 (View on PubMed)

Related Links

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Other Identifiers

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STUDY00161884

Identifier Type: -

Identifier Source: org_study_id

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