Pain reduction with an immersive digital therapeutic in women suffering from endometriosis-related pelvic pain: a randomized, controlled, open-label, two-parallel-group, interventional study (Preprint)

BACKGROUND Chronic pelvic pain is a frequent debilitating condition in women suffering from endometriosis. Pharmacological and surgical treatments are not always efficient in controlling pain and present important restriction. Digital Therapeutics (DTx) are emerging as major non-pharmacological alternatives, aiming to extend the analgesic therapeutic arsenal of the patients. OBJECTIVE In this randomized controlled trial (RCT), we aimed to measure the immediate and 4 hours persisting effects of a single use 20-minutes long DTx (Endocare) on pain in women suffering from pelvic pain related to endometriosis. METHODS Forty-five women suffering from endometriosis participated in a randomized controlled study comparing the analgesic effect of a single use of a virtual reality digital treatment (Endocare, n = 23) to a 2D digital control (n = 22). Perceived pain and pain relief were measured before the treatment and 15-, 30-, 45-, 60-, and 240-minutes after the end of the treatment. RESULTS The clustered post-treatment pain is significantly reduced compared to the pretreatment for both Endocare and the control group (all P<.01). Endocare was significantly more efficient than the control group (all P<.01). When comparing each post-treatment measures to the pretest, Endocare significantly reduces pain perception for all times up to 4 hours post-treatment. The differences didn’t reached significance for the control group. Moreover, Endocare was significantly superior to the control group for 15-, 30- and 45-minutes after the treatment (all P.05). CONCLUSIONS To our knowledge, our study is the first to test the effects of a single use of a DTx treatment on reported pain at different time points in patients diagnosed with endometriosis perceiving moderate-to-severe pelvic pain. Importantly, our result supports that Endocare, a VR immersive treatment, significantly reduce pain perception compared to a digital control in women suffering from endometriosis. Interestingly, we are the first to notice the effect persisted up to 4 hours post-treatment. CLINICALTRIAL ClinicalTrials.gov NCT04650516