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.

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.

• Authors: Vinod Dasa, Nebojsa V Skrepnik, Dena Petersen, Ronald E Delanois
• Journal: Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews (J Am Acad Orthop Surg Glob Res Rev) Vol. 6 Issue 9 (09 01 2022) ISSN: 2474-7661 [Electronic] United States
• PMID: 36094457 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2022 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Orthopaedic Surgeons.

Topics

• Double-Blind Method
• Electric Stimulation Therapy (methods)
• Humans
• Mobile Applications
• Osteoarthritis, Knee (therapy)
• Pain Measurement