Pos1372 innovative pain management device using millimetre band radiation: electronic-pain killer. assessment in patients with peripheral osteoarthritis. monocentric, prospective, randomised in cross-over design and controlled trial

Background Osteoarthritis (OA) is one of the most common chronic health conditions. Painful and very disabling, it affects about 500 million people worldwide. For its management, the different guidelines recommend a combination of non-pharmacological and pharmacological treatments [1]. However, 90% of the patients in the stop osteoarthritis I and II survey feel that they are poorly managed in terms of their OA pain and we currently lack effective means to do so [2]. We propose to assess an innovative medical device (MD) for neuromodulation of pain in patients with peripheral OA. This MD is a wristband and consists of a very low-power millimetre wave transmitter. The application of these waves on the wrist, a highly innervated area, has neuromodulatory effects thanks to the synthesis and release of endorphins and the activation of the parasympathetic system. Objectives We conducted a clinical trial to evaluate if the regular use of this MD would reduce the pain felt by the patient as well as his consumption of analgesics and if it would improve quality of life (QoL). Methods This prospective study was performed between December 2020 and august 2022. Sixty patients with a peripheral OA and a pain score ≥4 on the visual analogic scale (VAS) was included and randomised in one of the two cross-over group. The randomization is stratified on the most painful OA localisation (upper/lower limbs). Patients of group A followed a 3-month period with their conventional treatment (CT) and after they get the device in add on for 3 months. Those of group B started by using for 3 months the MD added on CT and after they took only CT for 3 months. Between the 2 periods, there was a one-month wash-out with only CT. Patients were instructed to perform 1 to 3 sessions/day with the wristband. The duration of each session was 40 minutes. The intern memory of the MD allowed to measure this frequency of use. After 7 days of wristband use, a phone call was performed to ensure that patient had no difficulties with the wristband. A follow-up phone call was also made once a month to remind the patient to use wristband, to report data and to collect potential adverse events. The primary outcome was the difference of pain score between the period with and without the wristband use. The primary endpoint was collected on the VAS every day during the last two weeks of each month of follow-up (i.e. months 1 to 3 and 5 to 7). The other parameters, collected at the inclusion and follow-up visits are specific QoL of OA (WOMAC questionnaire/DREISER index), generic QoL with EuroQuol5D-5L, anxiety-depression questionnaire (HADS), antalgics and cares consumption, the sleep quality on VAS, usability questionnaire (meCUE), patient use of the MD and adverse events. In the aim of a personalized medicine a comparison is made for each patient between the real evolution of their pain score and the decreases in the pain score that they felt having a relevant impact. Results All analyses were performed in intention to treat. The mean age of patients was 65.78±7.2 years old. At baseline all parameters were similar between the two groups except the number of male (group A: 5M; group B: 1M) and the body max index (group A: 24.29±4.01 kg/m 2 ; group B: 27.80±4.7 kg/m 2 ). The mean pain score at baseline was 6.17±1.43. For this cross-over study, there were no carryover, no sequence, and no period effect. The two groups difference on the pain score was significative (p<0.05) with a VAS of 4.57±2.0 in the MD group and 5.32±1.77 in the conventional treatment group. The effect size of the MD, calculated with the Cohen’s D formulae, was of 0.42. No serious adverse effect occurs. Conclusion We have demonstrated in this world first study the efficacy of this new medical device to reduce peripheral OA pain. Easy to use, discreet and safe, this free drug therapy opens a new field of OA pain treatment. References [1]D.J Hunter and al. Osteoarthritis. Lancet 2019; 393: 1745–59 [2]L Grange and al. Impact of osteoarthritis on patient QoL- POS0084-PARE - EULAR 2022 Acknowledgements The authors would like to thank AG2R – LA MONDIALE which was funded this trial. We would like to thank the rheumatologist physicians Nadine CORNET-DROGUET, Sophie DEROLEZ, Romain GASTALDI, Aurélie SICAUD, Mélanie TRABELSI and Myriam ZULIAN who preselected their patients for the study. Disclosure of Interests Caroline MAINDET: None declared, Joris GIAI: None declared, Anne DUMOLARD: None declared, Corentin LEROY: None declared, Marlène THIERS: None declared, David CROUZIER Employee of: I am employed by REMEDEE LABS SA, Emilie CHIPON Employee of: I am employed by REMEDEE LABS SA, Valentin PARAN: None declared, Marion PROUST: None declared, Gilliane LALAMI: None declared, Isabelle BOUDRY: None declared, Jean-Luc BOSSON: None declared, LAURENT GRANGE: None declared.