Abstract / Summary
Background: /Objectives: Among patients with rheumatoid arthritis (RA) and well-controlled inflammation, morning stiffness (MS) relief is an unmet need. Because MS is most pronounced immediately after waking, an intervention is necessary during sleep. We developed a low-temperature wrist warming device designed for overnight use and evaluated its feasibility, safety, and preliminary efficacy for improving MS.
Methods: In this single-arm, open-label pilot study, 15 patients with RA recorded MS severity and duration during 2 weeks with and 2 weeks without device use. Secondary outcomes included grip strength, disease activity, and musculoskeletal ultrasound (MSUS) findings of 22 wrist and finger joints. Synovitis was assessed using semi-quantitative grayscale (GS) and power Doppler (PD) grading scores.
Results: No burns occurred. Total GS and PD scores indicated no significant change after warming. A joint-level analysis indicated that most joints exhibited no change in grade. Only small bidirectional fluctuations occurred. No participant exhibited a pattern of progressive or widespread worsening. MS severity during the warming period was lower than that during the non-warming period (3.83 vs. 4.47; p = 0.0033). MS duration also decreased (99.8 vs. 124.2 min; p = 0.0049). Grip strength and Disease Activity Score 28 based on C-reactive protein remained unchanged.
Conclusions: Continuous, overnight, low-temperature wrist warming was feasible and safe, without burns or evidence of synovitis exacerbation on MSUS. The safety profile and preliminary evidence of reduced MS severity and duration support further evaluation of this home-based, non-pharmacologic approach in large-scale controlled trials.