Usefulness and safety of a wearable transcutaneous electrical nerve stimulation device for promoting exercise therapy in patients with chronic knee pain: A randomized controlled trial

Keisuke Yamada; Hiroki Shimizu; Naoki Doi; Keiko Harada; Mami Ishizuka-Inoue; Reika Yamashita; Shozo Takamatsu; Saki Hayashi-Nishiyama; Yukihiro Okamoto; Tomoki Aoyama

doi:10.1016/j.apmr.2024.08.021

Usefulness and safety of a wearable transcutaneous electrical nerve stimulation device for promoting exercise therapy in patients with chronic knee pain: A randomized controlled trial

Arch Phys Med Rehabil. 2024 Sep 7:S0003-9993(24)01226-7. doi: 10.1016/j.apmr.2024.08.021. Online ahead of print.

Affiliations

¹ Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Technology Development HQ, Strategic Clinical R&D Department, Omron Healthcare Co., Ltd, Kyoto, Japan.
² Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
³ Technology Development HQ, Strategic Clinical R&D Department, Omron Healthcare Co., Ltd, Kyoto, Japan.
⁴ Aoi Clinic, Osaka, Japan.
⁵ Department of Physical Therapy, Human Health Sciences, Graduate School of Medicine, Kyoto University, Kyoto, Japan. Electronic address: aoyama.tomoki.4e@kyoto-u.ac.jp.

PMID: 39251034
DOI: 10.1016/j.apmr.2024.08.021

Abstract

Objective: To investigate the effect of transcutaneous electrical nerve stimulation (TENS) in reducing barriers to the implementation of exercise therapy and promoting exercise therapy, focusing on physical activity.

Design: A single, participant-blinded, randomized controlled trial (RCT) with a pre-post design SETTING: Single-institution, orthopedic clinic PARTICIPANTS: Participants had knee pain for at least 3 months (N=63, ≥50 years of age) and were randomly assigned to the TENS (N=21), exercise (N=23), or combined (N=19) group.

Interventions: Participants were provided with 4 weeks of intervention: the TENS group using a wearable TENS device, exercise group performing designated exercises, and combined group performing activities from the TENS and exercise groups.

Main outcome measures: The primary outcome measure was physical activity (PA). The secondary outcome measures were 6-minute walk test (6MWT); timed up-and-go test (TUG); stair climbing; knee pain using the visual analog scale at 6MWT, TUG, and stair climbing; and patient-reported changes in knee pain over time.

Results: At pre- and post-intervention, light-intensity PA time (LPA) in the TENS, exercise, and combined groups was 735.62±68.82 vs. 714.21±73.06 (p=0.061), 733.05±103.90 vs. 700.31±90.33 (p=0.057), and 710.09±62.98 vs. 685.22±58.35 (p=0.049), respectively, with a significant decrease in the combined group. Significant improvement in knee pain and stair climbing was observed in all groups pre- and post-intervention.

Conclusions: The group using TENS showed improved effects of early reduction in knee pain and when combined with exercise therapy, a reduction in time spent in light-intensity activities such as sedentary behavior. Thus, the use of TENS in combination with conventional exercise therapy has the potential to reduce psychological barriers to the introduction of exercise therapy. It also promotes and ensures the safe implementation and continuation of exercise therapy.

Keywords: Osteoarthritis, knee; Pain management; Physical examination; Rehabilitation; Transcutaneous electrical nerve stimulation.