A Novel Mobile App-based Neuromuscular Electrical Stimulation Therapy for the Management of Knee Osteoarthritis: Results From an Extension Study of a Randomized, Double-blind, Sham-controlled, Multicenter Trial

Authors

• Vinod Dasa, LSU Health Sciences Center - New OrleansFollow
• Nebojsa V. Skrepnik, Tucson Orthopaedic Institute, Tucson, AZ
• Dena Petersen, Noble Clinical Research, Tucson, AZ
• Ronald E. Delanois, Sinai Hospital of Baltimore, Baltimore, MD

Document Type

Article

Publication Date

9-12-2022

Publication Title

Journal of the American Academy of Orthopaedic Surgeons. Global Research & Reviews

Abstract

BACKGROUND: Mobile app-based neuromuscular electrical stimulation (NMES) is a promising treatment of knee osteoarthritis as previously demonstrated in a 12-week, randomized, double-blind, sham-controlled, multicenter trial (parent study). METHODS: Sixty-four of the 253 patients with knee osteoarthrosis who completed the 12-week parent study were enrolled in a 14-week extension study during which they continued to receive double-blind, home-based NMES (two 20-minute daily sessions, 5 d/wk) with either the original device ("active NMES") or a low-voltage version ("sham NMES"). All subjects who enrolled in the extension study comprised the intent-to-treat population and subjects who applied NMES (compliance monitored through the mobile app and a remote portal) for at least 2,800 minutes (14-week device usage) comprised the per-protocol therapy compliant population. RESULTS: In the per-protocol therapy compliant population, the active NMES group (n = 21) had a higher reduction in Visual Analog Scale Nominated Activity (64.7% versus 24.3%, P = 0.020) and Visual Analog Scale Nominated Activity improvement ≥ 50% (76.2% versus 12.5%, P = 0.002) than the sham NMES group (n = 8). Outcomes were not markedly different between groups in the intent-to-treat population. DISCUSSION: Applying NMES therapy for an additional 14 weeks (totaling 26 weeks) resulted in notable and clinically meaningful pain relief when patients were fully compliant with NMES.

PubMed ID

36094457

Volume

6

Issue

9

Rights

© American Academy of Orthopaedic Surgeons

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Recommended Citation

Dasa, Vinod; Skrepnik, Nebojsa V.; Petersen, Dena; and Delanois, Ronald E., "A Novel Mobile App-based Neuromuscular Electrical Stimulation Therapy for the Management of Knee Osteoarthritis: Results From an Extension Study of a Randomized, Double-blind, Sham-controlled, Multicenter Trial" (2022). School of Medicine Faculty Publications. 4981.
https://digitalscholar.lsuhsc.edu/som_facpubs/4981
10.5435/JAAOSGlobal-D-22-00115