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P. Klemm, J. Bär, I. Aykara, K. Frommer, E. Neumann, U. Müller-Ladner, U. Lange
Published: 19 May 2021
 by  BMJ

Abstract: Background: More than 95% of patients with systemic sclerosis (SSc) suffer from Raynaud’s syndrome (RS) leading to digital ulcerations (DU). In severe RS, intravenous application of prostaglandins is required. Moreover, these patients profit from an additional non-pharmacological treatment using hyperthermia to increase vasodilatation and perfusion, and to reduce pain. Serial locally applied water-filtered infrared A radiation (sl-wIRAR) is a hyperthermia treatment modality using infrared heat radiation in the range of 780-1400nm with high tissue penetration and low thermal load on the skin surface [1]. wIRAR has both, temperature-dependent and non-dependent effects, which do not inherit thermal energy transfer and/or relevant temperature changes [1]. It is therefore not only used in acute and chronic wound healing as it promotes perfusion, alleviates pain and has anti-infectious effects [2], but is also used in oncology [3] and rheumatology [4]. Objectives: We conducted a randomized controlled trial with a follow-up visit after 2 weeks to evaluate the value of a high-frequent hyperthermia treatment using sl-wIRAR in comparison to a low-frequent hyperthermia treatment (our standard) in SSc patients with severe RS receiving Iloprost treatment. Methods: Eligible patients had SSc according to the 2013 ACR/EULAR classification criteria, were 18 to 80 years old and had RS requiring treatment with Iloprost in an in-patient setting. Key exclusion criteria were contraindications to any hyperthermia treatment such as infection or heat insensitivity. The trial was conducted at Campus Kerckhoff of Justus-Liebig University Giessen. Eligible patients were equally randomized to the intervention group (IG) receiving additional sl-wIRAR treatment (2 treatments for 30 min per day for 8 days) plus the standard of care (Iloprost treatment over 8 days plus daily carbon dioxide hand baths of 20 min) and the control group (CG) receiving only the standard of care. Primary outcome was the between-group difference in pain measured on a numeric rating scale (NRS) after intervention. Key secondary outcomes included a change in RS frequency, RS duration, and a change in Interleukin (IL) -6 and VEGF levels. Results: From 01.03.2020 to 31.12.2020 49 SSc patients met the inclusion criteria. 42 patients were enrolled (IG: 21, CG: 21). 38 patients (IG:19, CG: 19) completed the full trial period and were analyzed. There was no statistically significant between-group difference in pain levels (NRS) (p=0.284, Z -1.082 (Mann-Whitney U Test)) and thus the primary outcome was not met. Therefore, all p values for secondary outcomes are nominal. Intensity (Visual analogue scale 0-100mm) and duration (min) of RS were reduced in the IG (mean ± standard error) -14.579 ± 7.214 mm (p=0.058) and -2.917 ± 1.510 min (p=0.08), respectively. Intra- and inter-group comparison of IL-6 and VEGF levels showed no relevant change. Conclusion: The additive and frequent use of sl-wIRAR in the treatment of SSc patients with RS requiring Iloprost treatment does not improve outcomes regarding pain levels, RS intensity or frequency nor IL-6 and VEGF levels when compared to Iloprost treatment and low-frequent hyperthermia application. References: [1]Hoffmann G. Clinical applications of water-filtered infrared-A (wIRA) – a review. Phys Med Rehab Kuror. 2017;27(05):265–274. [2]Hoffmann G, Harte M, Mercer JB. Heat for wounds – water-fil- tered infrared-a (wIRA) for wound healing – a review. GMS Ger Med Sci. 2016;14:Doc08. [3]Notter M, Thomsen AR, Nitsche M, et al. Combined wIRA-hyperthermia and hypofractionated re-irradiation in the treatment of locally recurrent breast cancer: evaluation of therapeutic outcome based on a novel size classification. Cancers (Basel). 2020;12(3): 606. [4]Klemm P, Eichelmann M, Aykara I et al. Serial locally applied water-filtered infrared a radiation in axial spondyloarthritis – a randomized controlled trial, International Journal of Hyperthermia, 37:1, 965-970. Acknowledgements: We acknowledge the help of Carina Schreiyäck. This study was in part supported by the Dr. med. h.c. Erwin Braun Foundation, Basel, a charitable, nonprofit Swiss scientific foundation approved by the Swiss Federal Administration. The foundation supports clinical investigation of waterfiltered infrared-A. The foundation was not involved in any content- or decision-related aspect of the study. This study was prospectively registered at (German Registry of Clinical Studies): DRKS00021098 Disclosure of Interests: None declared
Keywords: treatment / SSc / Serial locally applied / applied water filtered / INFRARED A RADIATION / locally applied water

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