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.

Keywords: RCT; chronic pain; digital health; digital intervention; digital therapeutics; digital treatment; eHealth; effectiveness; efficacy; endometriosis; endometrium; gynecologist; gynecology; pain; pelvic; pelvic pain; pelvis; randomized controlled trial; reproductive health; sexual health; virtual reality; women's health.

Figure 1

Visual display of the 3D virtual reality treatment (ie, Endocare) and the 2D tablet control.

Figure 2

Difference in pain perception between baseline and the 5 clustered posttreatment measurements. Mean pain perception (± standard error) in both groups (ie, Endocare, control) at baseline (black: T0) and the 5 clustered posttreatment measurements (white: T15, T30, T45, T60, and T240). ##P<.01 (interaction group*time); **P<.01 (mixed model) ***P<.001 (mixed model).

Figure 3

Difference in pain perception before and each of the 5 posttreatments measurements. Mean pain perception (± standard error) in both groups (bold line: Endocare; dash-line: control) at baseline (T0) and each of the 5 posttreatment measurements (T15, T30, T45, T60, or T240). +P<.05 (t test); *P<.05 (mixed model).

Figure 4

Difference in pain relief at each of the 5 posttreatment measurements. Percentage of pain relief (± standard error of the mean) in both groups (circles and bold line: Endocare; squares and dash-line: control) at each of the 5 posttreatment measurements (T15, T30, T45, T60, or T240). +P<.05 (Wilcoxon).