Effects of locally applied water-filtered infrared a irradiation adjunctive to iloprost and carbon dioxide hand baths in patients with systemic sclerosis and severe Raynaud's phenomenon - a randomized controlled trial

Clinical Snapshot

Key Findings

• P Value: p = 0.041

• Effect Size: Mean difference -14.7mm favoring wIRA

• Primary Outcome: Pain VAS reduction: wIRA group 70.4→56.7mm vs control 73.9→65.3mm

• Nnt Or Sensitivity: NNT not calculable from continuous outcome data provided

• Confidence Interval: 95% CI [-28.8; -0.7]

Clinical Application

wIRA equipment available but requires specialized setup; 2×30min daily sessions may be resource-intensive Iloprost available on PBS for SSc; wIRA not currently PBS-listed but available privately; would require RACGP/ARA guideline consideration SSc patients with severe RP requiring iloprost therapy in tertiary rheumatology centers

Abstract

BACKGROUND: Almost all patients with systemic sclerosis (SSc) experience Raynaud's phenomenon (RP) with risk of digital ulcers (DU). In severe RP, intravenous iloprost is standard, yet additive hyperthermic therapy may enhance vasodilation and microcirculation. However, whether more intensive or alternative hyperthermic modalities offer benefits beyond commonly used CO2 hand baths remains unclear. METHODS: In this randomized, controlled trial, all patients received a baseline therapy of iloprost plus CO2 hand baths. The intervention group (IG) received additional water-filtered infrared-A (wIRA; 2 × 30 min/day, 8 days), while the control group (CG) received baseline therapy alone. The primary endpoint was the difference in RP-associated pain (VAS 0-100 mm) after treatment. Secondary outcomes included changes in RP duration, frequency, and intensity, Health Assessment Questionnaire (HAQ), serum interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF). RESULTS: Of 46 randomized patients, 38 (IG = 19, CG = 19) completed the study. Pain decreased from 70.4 ± 27.8 to 56.7 ± 21.4 mm with wIRA and from 73.9 ± 27.5 to 65.3 ± 26.8 mm in controls. Multivariable ANCOVA showed a mean difference of -14.7, 95% CI [-28.8;-0.7], p = 0.041 in favor of wIRA. RP duration improved more in the wIRA group (day 23: β = -3.8, 95% CI [-7.4;-0.2], p = 0.041), while RP frequency, intensity, HAQ, IL-6, and VEGF showed no significant differences (all p > 0.05). No adverse events occurred. CONCLUSIONS: Adjunctive wIRA during iloprost therapy was safe and yielded modest, short-term improvements in pain and RP duration. These exploratory effects warrant confirmation in larger controlled trials.