Investigational Treatment of Rheumatoid Arthritis with a Vibrotactile Device Applied to the External Ear

Abstract

Abstract Rheumatoid arthritis (RA) is a debilitating polyarthritis characterized by joint tissue inflammation. Here, we assessed the effect of applying a vibrotactile device to the external ear on inflammatory responses in healthy subjects, as well as its effect on disease activity in patients with RA. We enrolled 19 healthy subjects in a randomized cross-over study, delivered vibrotactile treatment at either the external ear or gastrocnemius, and performed ex vivo whole blood assays. Vibrotactile treatment at the external ear significantly reduced TNF, IL-1β, and IL-6 levels compared to pre-treatment baseline (TNF p<0.05, IL-1β p<0.005, IL-6 p<0.005), whereas treatment at the gastrocnemius did not attenuate inflammatory responses. Vibrotactile treatment at the external ear inhibited TNF by 80% (mean ± SD: pre-treatment = 4541 ± 2721 pg/ml vs. post-treatment = 3624 ± 2810 pg/ml), IL-6 by 73% (mean ± SD: pre-treatment = 5979 ± 2094 pg/ml vs post-treatment = 4342 ± 2600 pg/ml), and IL-1β by 50% (mean ± SD: pre-treatment = 1527 ± 1429 pg/ml vs post-treatment = 765 ± 968 pg/ml) as compared to pre-treatment baseline levels. 9 patients with RA were enrolled in a prospective interventional study. Vibrotactile treatment at the external ear significantly decreased DAS28-CRP scores two days post-treatment (DAS28-CRP score mean ± SD: pre-treatment = 3.4 ± 1.4 [1.27–5.67] vs. post-treatment = 2.7 ± 0.9 [1.24–4.37], p<0.005). DAS28-CRP scores remained significantly reduced 7 days post-treatment (DAS28-CRP score mean ± SD: 7 days post-treatment = 2.4 ± 0.7 [1.21–3.68]; p<0.005). These data demonstrate that application of a vibrotactile device to the external ear attenuates systemic inflammatory responses in both healthy subjects and patients with RA.