Background Chronic pelvic pain is a common and disabling condition in women living with endometriosis. Pharmacological and surgical treatments are not always effective at controlling pain and present important restrictions. Digital therapeutics (DTx) are emerging as major nonpharmacological alternatives that aim to extend the analgesic therapeutic arsenal of patients. Objective In this randomized controlled trial (RCT), we aimed to measure the immediate and 4-hour persisting effects of a single use 20-minute DTx (Endocare) on pain in women experiencing pelvic pain due to endometriosis. Methods A total of 45 women with endometriosis participated in a randomized controlled study comparing the analgesic effect of a single use of a virtual reality digital treatment named Endocare (n=23, 51%) to a 2D digital control (n=22, 49%). 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 posttreatment pain was significantly reduced compared to the pretreatment for both Endocare and the control group (all P<.01). Endocare was significantly more effective than the control group (all P<.01). Endocare decreased the mean pain intensity from 6.0 (SD 1.31) before the treatment to 4.5 (SD 1.71) posttreatment, while the control only decreased it from 5.7 (SD 1.36) to 5.0 (SD 1.43). When comparing each posttreatment measures to the pretest, Endocare significantly reduced pain perception for all points in time up to 4 hours posttreatment. The differences did not reached significance for the control group. Moreover, Endocare was significantly superior to the control group 15, 30, and 45 minutes after the treatment (all P<.001). The mean perceived pain relief was significantly higher for Endocare at 28% (SD 2%) compared to the control, which was 15% (SD 1%) for all the posttreatment measurements (all P>.05). Conclusions Our study aimed to test the effects of a single use of a DTx treatment on reported pain at different time points in women diagnosed with endometriosis experiencing moderate-to-severe pelvic pain. Importantly, our results support that Endocare, a virtual reality immersive treatment, significantly reduce pain perception compared to a digital control in women living with endometriosis. Interestingly, we are the first to notice that the effect persisted up to 4 hours posttreatment. Trial Registration ClinicalTrials.gov NCT04650516; https://tinyurl.com/2a2eu9wv

Background The management of chronic pelvic pain in women with endometriosis is complex and includes the long-term use of opioids. Patients not fully responsive to drugs or ineligible for surgical treatments need efficient alternatives to improve their quality of life and avoid long-term sequelae. Objective This randomized controlled trial aimed to assess the effects of repeated at-home administrations of a 20-minute virtual reality (VR) solution (Endocare) compared with a sham condition on pain in women experiencing pelvic pain due to endometriosis. Methods Patients were instructed to use the VR headsets twice daily for at least 2 days and for up to 5 days starting on their first day of painful periods. Pain perception was measured using a numerical scale (0-10) before and 60, 120, and 180 minutes after each treatment administration. General pain, stress, fatigue, medication intake, and quality of life were reported daily by patients. Results A total of 102 patients with endometriosis were included in the final analysis (Endocare group: n=51, 50%; sham group: n=51, 50%). The mean age was 32.88 years (SD 6.96) and the mean pain intensity before treatment was 6.53 (SD 1.74) and 6.22 (SD 1.69) for the Endocare group and the sham control group, respectively (P=.48). Pain intensity decreased in both groups from day 1 to day 5 along with a decrease in medication use. Maximum pain intensity reduction of 51.58% (SD 35.33) occurred at day 2, 120 minutes after treatment for the Endocare group and of 27.37% (SD 27.23) at day 3, 180 minutes after treatment for the control group. Endocare was significantly superior to the sham on day 1 (120 minutes, P=.04; 180 minutes, P=.001), day 2 (0 minutes, P=.02; 60, 120, and 180 minutes, all P<.001), and day 3 (60 minutes, P=.01; 120 minutes, P=.005; 180 minutes, P=.001). Similarly, the mean perceived pain relief was significantly higher with Endocare on day 1 (120 and 180 minutes P=.004 and P=.001, respectively) and day 2 (60, 120, and 180 minutes P=.003, P=.004, and P=.007, respectively) compared to the control. No adverse event was reported. Conclusions This study confirmed the effectiveness and safety of self-repeated administrations of a VR immersive treatment used at home while reducing overall pain medication intake in women diagnosed with endometriosis experiencing moderate-to-severe pelvic pain. Trial Registration ClinicalTrials.gov NCT05172492; https://clinicaltrials.gov/ct2/show/NCT05172492

BACKGROUND The management of chronic pelvic pain in women with endometriosis is complex and includes long-term use of opioids. Patients not fully responsive to drugs, or ineligible for surgical treatments need efficient alternatives to improve their quality of life and avoid long-term sequelae. OBJECTIVE This randomized controlled trial, software under test (Endocare) vs. sham, aimed to assess the effects of repeated at home administrations of a 20-minutes virtual reality (VR) solution on pain in women experiencing pelvic pain due to endometriosis. METHODS Patients were instructed to use VR headsets twice daily during at least 2 days and up to 5 days starting on their first day of painful periods. Pain perception was measured using a numerical scale (0 – 10) before and 60, 120, 180 minutes after each treatment administration. General pain, stress, fatigue, medication intake and quality of life were daily reported by patients. RESULTS 102 patients were included in the final analysis (mean age 32.88 years (SD 6.96)). The mean pain intensity before treatment was 6.53 (SD 1.74) and 6.22 (SD 1.69) for the Endocare group and the control group. Pain intensity decreased in both groups from day 1 to day 5 as well as medication use. Maximum pain intensity reduction was 51.58% (SD 35.33) at D2.T120 and 27.37% (SD 27.23) at D3.T180 for the Endocare group and the control group respectively. The Endocare was significantly superior to the sham on day 1 (T120, T180), day 2 and day 3 (T60, T120, T180). Similarly, the mean perceived pain relief was significantly higher with Endocare on day 1 (T120, T180) and day 2 (T60, T120, T180) compared to the control. No adverse event was reported. CONCLUSIONS This study confirmed the effectiveness and safety of self-repeated administrations of a virtual reality immersive treatment used at home while reducing overall pain medication intake in women diagnosed with endometriosis experiencing moderate-to-severe pelvic pain and supports. CLINICALTRIAL ClinicalTrials.gov: NCT05172492

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<.001). The mean perceived pain relief was significantly higher for Endocare compared to the control for all the post-treatment measurements (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