Beyond its effect on vegetative functions, the activation of the vagus nerve inhibits inflammation and reduces pain signaling. The aim of this open-label pilot study was to determine the efficacy and tolerance of transcutaneous auricular VNS (taVNS) on erosive hand osteoarthritis (EHOA) symptoms. Symptomatic EHOA patients with hand pain VAS ≥ 40/100 mm and ≥1 interphalangeal swollen joint(s) were included. The taVNS was performed for 4 weeks using an auricular electrode applied one hour per day and connected to a TENS device with pre-established settings. Clinical efficacy was evaluated by changes between baseline and at 4 weeks with hand pain VAS and the functional index FIHOA score, using a Wilcoxon t-test. The treatment tolerance was also evaluated. Eighteen patients (median age 69 years old, 83% women) were analyzed. At baseline, hand pain VAS was 60 mm [IQR 50; 78.2] and FIHOA 15 [10.7; 20.2]. After 4 weeks, taVNS significantly reduced hand pain VAS, with a median decrease of 23.5 mm [7.7; 37.2] (p = 0.001), as well as FIHOA, with a median decrease of 2 points [0.75; 5.2] (p = 0.01). No serious adverse events were reported. One patient stopped taVNS because of auricular discomfort. This first proof-of-concept trial indicated that taVNS is feasible and may decrease joint inflammation and clinical symptoms in EHOA, arguing for a randomized controlled study versus sham stimulation.
to 2.5 years later, we evaluated outcomes (KR, WOMAC pain) at time-points after 2.5 years up to 7 years. Results: Overall, 1755 subjects (2554 knees) met inclusion criteria (mean age 62, 64% female, 86.5% White, mean WOMAC pain 2.7). 113 knees underwent KR overall (4.4%), whereas of those knees that were JSN¼2 at baseline, 19.8% (41/258) underwent KR and of those knees with WOMAC 8-18 at baseline, 10.2% (25/244) underwent KR. Overall, both severity and extent of baseline cartilage lesions as well as change in cartilage lesions over 2.5 years were significantly associated with risk of KR (Table). In contrast, while cartilage lesions were significantly associated with WOMAC pain severity, the relationship was weak (Table). Conclusions: These findings support the clinical relevance of cartilage lesions to the clinically important endpoint of KR. Further, relatively short-term changes in cartilage lesions over 2.5 years may be potentially useful as a prognostic marker for later clinical endpoints such as KR. However, the magnitude of these effects estimates may not be sufficient for validation as an imaging biomarker. In contrast, cartilage lesions were not strongly associated with WOMAC pain. This may partly reflect the uncertainty in the utility of WOMAC pain as an instrument to detect long-term change in pain over years since WOMAC has primarily been used and validated in RCTs to date that are of 3-6 months rather than years-long studies.
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