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

Benjamin Merlot, Garance Dispersyn, Zoé Husson, Isabella Chanavaz-Lacheray, Thomas Dennis, Juliette Greco-Vuilloud, Maxime Fougère, Stéphane Potvin, Maryne Cotty-Eslous, Horace Roman, Serge Marchand, Benjamin Merlot, Garance Dispersyn, Zoé Husson, Isabella Chanavaz-Lacheray, Thomas Dennis, Juliette Greco-Vuilloud, Maxime Fougère, Stéphane Potvin, Maryne Cotty-Eslous, Horace Roman, Serge Marchand

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.

Conflict of interest statement

Conflicts of Interest: None declared.

©Benjamin Merlot, Garance Dispersyn, Zoé Husson, Isabella Chanavaz-Lacheray, Thomas Dennis, Juliette Greco-Vuilloud, Maxime Fougère, Stéphane Potvin, Maryne Cotty-Eslous, Horace Roman, Serge Marchand. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 21.09.2022.

Figures

Figure 1
Figure 1
Visual display of the 3D virtual reality treatment (ie, Endocare) and the 2D tablet control.
Figure 2
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
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
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).

References

    1. Vercellini P, Viganò P, Somigliana E, Fedele L. Endometriosis: pathogenesis and treatment. Nat Rev Endocrinol. 2014 May;10(5):261–75. doi: 10.1038/nrendo.2013.255.nrendo.2013.255
    1. Saunders PTK, Horne AW. Endometriosis: Etiology, pathobiology, and therapeutic prospects. Cell. 2021 May 27;184(11):2807–2824. doi: 10.1016/j.cell.2021.04.041. S0092-8674(21)00576-6
    1. Taylor HS, Kotlyar AM, Flores VA. Endometriosis is a chronic systemic disease: clinical challenges and novel innovations. Lancet. 2021 Feb 27;397(10276):839–852. doi: 10.1016/S0140-6736(21)00389-5.S0140-6736(21)00389-5
    1. Giudice LC. Clinical practice. Endometriosis. N Engl J Med. 2010 Jun 24;362(25):2389–98. doi: 10.1056/NEJMcp1000274. 362/25/2389
    1. Tirlapur S A, Kuhrt K, Chaliha C, Ball E, Meads C, Khan K S. The 'evil twin syndrome' in chronic pelvic pain: a systematic review of prevalence studies of bladder pain syndrome and endometriosis. Int J Surg. 2013 May;11(3):233–7. doi: 10.1016/j.ijsu.2013.02.003. S1743-9191(13)00034-4
    1. Guo S, Wang Y. The prevalence of endometriosis in women with chronic pelvic pain. Gynecol Obstet Invest. 2006;62(3):121–30. doi: 10.1159/000093019.93019
    1. Dydyk A, Gupta N. Chronic Pelvic Pain. Treasure Islands, FL: StatPearls Publishing; 2022. May 29,
    1. Garcia LM, Birckhead BJ, Krishnamurthy P, Sackman J, Mackey IG, Louis RG, Salmasi V, Maddox T, Darnall BD. An 8-week self-administered at-home behavioral skills-based virtual reality program for chronic low back pain: double-blind, randomized, placebo-controlled trial conducted during COVID-19. J Med Internet Res. 2021 Feb 22;23(2):e26292. doi: 10.2196/26292. v23i2e26292
    1. Carbone MG, Campo G, Papaleo E, Marazziti D, Maremmani I. The Importance of a Multi-Disciplinary Approach to the Endometriotic Patients: The Relationship between Endometriosis and Psychic Vulnerability. J Clin Med. 2021 Apr 10;10(8) doi: 10.3390/jcm10081616. jcm10081616
    1. Mechsner S. Management of endometriosis pain : Stage-based treatment strategies and clinical experience. Schmerz. 2021 Jun;35(3):159–171. doi: 10.1007/s00482-021-00543-8.10.1007/s00482-021-00543-8
    1. Vercellini P, Buggio L, Frattaruolo MP, Borghi A, Dridi D, Somigliana E. Medical treatment of endometriosis-related pain. Best Pract Res Clin Obstet Gynaecol. 2018 Aug;51:68–91. doi: 10.1016/j.bpobgyn.2018.01.015.S1521-6934(18)30033-6
    1. Wattier J. Conventional analgesics and non-pharmacological multidisciplinary therapeutic treatment in endometriosis: CNGOF-HAS Endometriosis Guidelines. Gynecol Obstet Fertil Senol. 2018 Mar;46(3):248–255. doi: 10.1016/j.gofs.2018.02.002.S2468-7189(18)30034-5
    1. Kold M, Hansen T, Vedsted-Hansen H, Forman A. Mindfulness-based psychological intervention for coping with pain in endometriosis. Nord Psychol. 2012 Aug 31;64(1):2–16. doi: 10.1080/19012276.2012.693727.
    1. Jia S, Leng J, Shi J, Sun P, Lang J. Health-related quality of life in women with endometriosis: a systematic review. J Ovarian Res. 2012 Oct 18;5(1):29. doi: 10.1186/1757-2215-5-29. 1757-2215-5-29
    1. Kennedy S, Bergqvist A, Chapron C, D'Hooghe T, Dunselman G, Greb R, Hummelshoj L, Prentice A, Saridogan E. ESHRE guideline for the diagnosis and treatment of endometriosis. Hum Reprod. 2005 Oct;20(10):2698–704. doi: 10.1093/humrep/dei135.dei135
    1. Ball E, Khan KS. Recent advances in understanding and managing chronic pelvic pain in women with special consideration to endometriosis. F1000Res. 2020 Feb 4;9:83. doi: 10.12688/f1000research.20750.1.
    1. Meissner K, Schweizer-Arau A, Limmer A, Preibisch C, Popovici R, Lange I, de Oriol B, Beissner F. Psychotherapy with somatosensory stimulation for endometriosis-associated pain: a randomized controlled trial. Obstet Gynecol. 2016 Nov;128(5):1134–1142. doi: 10.1097/AOG.0000000000001691.00006250-201611000-00028
    1. Dang A, Arora D, Rane P. Role of digital therapeutics and the changing future of healthcare. J Family Med Prim Care. 2020 May;9(5):2207–2213. doi: 10.4103/jfmpc.jfmpc_105_20. JFMPC-9-2207
    1. Bordeleau M, Stamenkovic A, Tardif P, Thomas J. The Use of Virtual Reality in Back Pain Rehabilitation: A Systematic Review and Meta-Analysis. J Pain. 2022 Feb;23(2):175–195. doi: 10.1016/j.jpain.2021.08.001.S1526-5900(21)00311-4
    1. Chow H, Hon J, Chua W, Chuan A. Effect of virtual reality therapy in reducing pain and anxiety for cancer-related medical procedures: a systematic narrative review. J Pain Symptom Manage. 2021 Feb;61(2):384–394. doi: 10.1016/j.jpainsymman.2020.08.016.S0885-3924(20)30695-3
    1. Chuan A, Zhou JJ, Hou RM, Stevens CJ, Bogdanovych A. Virtual reality for acute and chronic pain management in adult patients: a narrative review. Anaesthesia. 2021 May 27;76(5):695–704. doi: 10.1111/anae.15202. doi: 10.1111/anae.15202.
    1. Ding L, Hua H, Zhu H, Zhu S, Lu J, Zhao K, Xu Q. Effects of virtual reality on relieving postoperative pain in surgical patients: A systematic review and meta-analysis. Int J Surg. 2020 Oct;82:87–94. doi: 10.1016/j.ijsu.2020.08.033.S1743-9191(20)30636-1
    1. López-Valverde N, Muriel-Fernández J, López-Valverde A, Valero-Juan LF, Ramírez JM, Flores-Fraile J, Herrero-Payo J, Blanco-Antona LA, Macedo-de-Sousa B, Bravo M. Use of virtual reality for the management of anxiety and pain in dental treatments: systematic review and meta-analysis. J Clin Med. 2020 Sep 24;9(10):3086. doi: 10.3390/jcm9103086. jcm9103086
    1. Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. JPR. 2019 Jul;Volume 12:2053–2085. doi: 10.2147/jpr.s200498.
    1. Boyle Y, Bentley D, Watson A, Jones A. Acoustic noise in functional magnetic resonance imaging reduces pain unpleasantness ratings. Neuroimage. 2006 Jul 01;31(3):1278–83. doi: 10.1016/j.neuroimage.2006.01.025.S1053-8119(06)00090-5
    1. Ecsy K, Jones A, Brown C. Alpha-range visual and auditory stimulation reduces the perception of pain. Eur J Pain. 2017 Mar 02;21(3):562–572. doi: 10.1002/ejp.960.
    1. Farzaneh M, Abbasijahromi A, Saadatmand V, Parandavar N, Dowlatkhah HR, Bahmanjahromi A. Comparative effect of nature-based sounds intervention and headphones intervention on pain severity after cesarean section: a prospective double-blind randomized trial. Anesth Pain Med. 2019 Apr;9(2):e67835. doi: 10.5812/aapm.67835.
    1. Gerlinger C, Schumacher U, Faustmann T, Colligs A, Schmitz H, Seitz C. Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials. Health Qual Life Outcomes. 2010 Nov 24;8:138. doi: 10.1186/1477-7525-8-138. 1477-7525-8-138
    1. Facchin F, Barbara G, Saita E, Mosconi P, Roberto A, Fedele L, Vercellini P. Impact of endometriosis on quality of life and mental health: pelvic pain makes the difference. J Psychosom Obstet Gynaecol. 2015;36(4):135–41. doi: 10.3109/0167482X.2015.1074173.
    1. Arendsen LJ, Henshaw J, Brown CA, Sivan M, Taylor JR, Trujillo-Barreto NJ, Casson AJ, Jones AKP. Entraining alpha activity using visual stimulation in patients with chronic musculoskeletal pain: a feasibility study. Front Neurosci. 2020 Aug 20;14:828. doi: 10.3389/fnins.2020.00828. doi: 10.3389/fnins.2020.00828.
    1. Terho A, Puhto T, Laru J, Uimari O, Ohtonen P, Rautio T, Koivurova S. Laparoscopically guided transversus abdominis plane block versus local wound analgesia in laparoscopic surgery for peritoneal endometriosis: study protocol for a prospective randomized controlled double-blinded LTAP-trial. Trials. 2022 Jan 18;23(1):55. doi: 10.1186/s13063-022-06004-6. 10.1186/s13063-022-06004-6
    1. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J, IMMPACT Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9–19. doi: 10.1016/j.pain.2004.09.012.S0304-3959(04)00440-3
    1. Bermo M, Patterson D, Sharar S, Hoffman H, Lewis D. Virtual reality to relieve pain in burn patients undergoing imaging and treatment. Top Magn Reson Imaging. 2020 Aug;29(4):203–208. doi: 10.1097/RMR.0000000000000248.00002142-202008000-00007
    1. Frey DP, Bauer ME, Bell CL, Low LK, Hassett AL, Cassidy RB, Boyer KD, Sharar SR. Virtual reality analgesia in labor. Anesth Analg. 2019;128(6):e93–e96. doi: 10.1213/ane.0000000000003649.
    1. Guo C, Deng H, Yang J. Effect of virtual reality distraction on pain among patients with hand injury undergoing dressing change. J Clin Nurs. 2015 Jan 04;24(1-2):115–20. doi: 10.1111/jocn.12626.
    1. Pourmand A, Davis S, Marchak A, Whiteside T, Sikka N. Virtual reality as a clinical tool for pain management. Curr Pain Headache Rep. 2018 Jun 15;22(8):53. doi: 10.1007/s11916-018-0708-2.10.1007/s11916-018-0708-2
    1. Mosso-Vázquez JL, Gao K, Wiederhold BK, Wiederhold MD. Virtual reality for pain management in cardiac surgery. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):371–8. doi: 10.1089/cyber.2014.0198.
    1. JahaniShoorab N, Ebrahimzadeh Zagami S, Nahvi Ali, Mazluom SR, Golmakani N, Talebii M, Pabarja F. The effect of virtual reality on pain in primiparity women during episiotomy repair: a randomize clinical trial. Iran J Med Sci. 2015 May;40(3):219–24.
    1. Jin W, Choo A, Gromala D, Shaw C, Squire P. A virtual reality game for chronic pain management: a randomized, controlled clinical study. Stud Health Technol Inform. 2016;220:154–60.
    1. Jones T, Moore T, Choo J. The impact of virtual reality on chronic pain. PLoS One. 2016 Dec 20;11(12):e0167523. doi: 10.1371/journal.pone.0167523. PONE-D-16-26747
    1. Wiederhold BK, Gao K, Sulea C, Wiederhold MD. Virtual reality as a distraction technique in chronic pain patients. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):346–52. doi: 10.1089/cyber.2014.0207.
    1. Osumi M, Ichinose A, Sumitani M, Wake N, Sano Y, Yozu A, Kumagaya S, Kuniyoshi Y, Morioka S. Restoring movement representation and alleviating phantom limb pain through short-term neurorehabilitation with a virtual reality system. Eur J Pain. 2017 Jan 05;21(1):140–147. doi: 10.1002/ejp.910.
    1. Ichinose A, Sano Y, Osumi M, Sumitani M, Kumagaya S, Kuniyoshi Y. Somatosensory feedback to the cheek during virtual visual feedback therapy enhances pain alleviation for phantom arms. Neurorehabil Neural Repair. 2017 Aug 08;31(8):717–725. doi: 10.1177/1545968317718268.
    1. Moore R, Derry S, McQuay HJ, Wiffen P. Single dose oral analgesics for acute postoperative pain in adults. Cochrane Database Syst Rev. 2011 Sep 07;(9):CD008659. doi: 10.1002/14651858.CD008659.pub2.
    1. Casciaro F, Laterza V, Conte S, Pieralice M, Federici A, Todarello O, Orsucci F, Conte E. Alpha-rhythm stimulation using brain entrainment enhances heart rate variability in subjects with reduced HRV. WJNS. 2013;03(04):213–220. doi: 10.4236/wjns.2013.34028.
    1. Le Scouarnec RP, Poirier RM, Owens JE, Gauthier J, Taylor AG, Foresman PA. Use of binaural beat tapes for treatment of anxiety: a pilot study of tape preference and outcomes. Altern Ther Health Med. 2001 Jan;7(1):58–63.
    1. Pickens TA, Khan SP, Berlau DJ. White noise as a possible therapeutic option for children with ADHD. Complement Ther Med. 2019 Feb;42:151–155. doi: 10.1016/j.ctim.2018.11.012.S0965-2299(18)30968-3
    1. Farokhnezhad Afshar P, Bahramnezhad F, Asgari P, Shiri M. Effect of white noise on sleep in patients admitted to a coronary care. J Caring Sci. 2016;5(2):103–9. doi: 10.15171/jcs.2016.011.
    1. Stanchina ML, Abu-Hijleh M, Chaudhry BK, Carlisle CC, Millman RP. The influence of white noise on sleep in subjects exposed to ICU noise. Sleep Med. 2005 Sep;6(5):423–8. doi: 10.1016/j.sleep.2004.12.004.S1389-9457(04)00224-2
    1. Papalambros NA, Santostasi G, Malkani RG, Braun R, Weintraub S, Paller KA, Zee PC. Acoustic enhancement of sleep slow oscillations and concomitant memory improvement in older adults. Front Hum Neurosci. 2017 Mar 08;11:109. doi: 10.3389/fnhum.2017.00109. doi: 10.3389/fnhum.2017.00109.
    1. Zhou J, Liu D, Li X, Ma J, Zhang J, Fang J. Pink noise: effect on complexity synchronization of brain activity and sleep consolidation. J Theor Biol. 2012 Aug 07;306:68–72. doi: 10.1016/j.jtbi.2012.04.006.S0022-5193(12)00179-8
    1. Saadatmand V, Rejeh N, Heravi-Karimooi M, Tadrisi SD, Zayeri F, Vaismoradi M, Jasper M. Effect of nature-based sounds' intervention on agitation, anxiety, and stress in patients under mechanical ventilator support: a randomised controlled trial. Int J Nurs Stud. 2013 Jul;50(7):895–904. doi: 10.1016/j.ijnurstu.2012.11.018.S0020-7489(12)00420-8
    1. Tesarz J, Leisner S, Gerhardt A, Janke S, Seidler GH, Eich W, Hartmann M. Effects of eye movement desensitization and reprocessing (EMDR) treatment in chronic pain patients: a systematic review. Pain Med. 2014 Feb 05;15(2):247–63. doi: 10.1111/pme.12303.
    1. Bani Mohammad E, Ahmad M. Palliative & Supportive Care. Cambridge, UK: Cambridge University Press; 2018. Sep 10, Virtual reality as a distraction technique for pain and anxiety among patients with breast cancer: A randomized control trial; p. A.
    1. Persky S, Lewis M. Advancing science and practice using immersive virtual reality: what behavioral medicine has to offer. Transl Behav Med. 2019 Nov 25;9(6):1040–1046. doi: 10.1093/tbm/ibz068. 5497399
    1. Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105–21. doi: 10.1016/j.jpain.2007.09.005.S1526-5900(07)00899-1

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi