Pain Reduction With an Immersive Digital Therapeutic Tool in Women Living With Endometriosis-Related Pelvic Pain: Randomized Controlled Trial

Abstract

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

Pain Reduction With an Immersive Digital Therapeutic in Women Living With Endometriosis-Related Pelvic Pain: At-Home Self-Administered Randomized Controlled Trial

“…This study also confirmed the effect of VR itself (digital control) when associated with nature sounds, which is already used to reduce pain during surgery or for patients in intensive care [39,40]: its immersive effect has a direct impact on pain as observed in previous work [22,28,29,[41][42][43][44][45][46][47][48][49][50][51]. Interestingly, compared to our previous study [24], the upgraded sham delivering the same audio/video content but in an immersive VR headset instead of a tablet achieved higher pain intensity reduction when used on a similar population.…”

“…However, most studies on VR for pain have been conducted in a medical context under the supervision of a health care team [24][25][26][27] and only few are conducted at patients' homes with treatment self-administered by the patients themselves [28]. In fact, most of the medical devices developed to treat pain, either acute or chronic, are designed to be used by medical staff in a medical setting [24,27,[29][30][31][32].…”

The Use of Virtual Reality in the Rehabilitation of Chronic Nonspecific Neck Pain

“…However, despite these issues, our sensitivity analysis still showed a significant effect across all clinically important outcomes in all retrieved studies; it is unlikely that this is due to chance alone. Furthermore, the analgesic effect of VR is not limited to CNNP, studies in chronic low back pain, 43 traumatic and nontraumatic pain in emergency patients, 44 and endometriosis-related pelvic pain 45 show significant pain modulation effects of VR. These reports suggest that the use of VR may be effective for other types of acute and chronic pain.…”

Endometriosis – a painful disease

“…There is also increasing interest both from researchers and general public in ‘femtech’ broadly and how it can be applied to endometriosis. However, it is important for such advances to be tested thoroughly, with rigorous clinical trials with appropriate placebo controls [46 ▪ ]. When new technologies are developed and marketed without full clinical trials, a rift is created between consumer healthcare markets and clinical guidelines [43,47].…”