Endocare for Pelvic-perineal Pain Related to Endometriosis Used at Home

Efficacy of Endocare Treatment at Home on Pain in Women With Chronic Pelvic-perineal Pain Related to Endometriosis. EndoHome.

Women with endometriosis experience recurrent pelvic-perineal pain impairing the quality of life, among other things. Endometriosis-related pain negatively impacts the sexual, family and work life.

Apart from the usual painkillers, the doctor's current therapeutic arsenal is limited to hormonal contraceptives and surgery. As endometriosis-related treatments do not currently address all of the patients' problems, developing a new, effective, non-pharmaceutical treatment would make it possible to relieve the pain of these women.

Endocare treatment consists of visual and auditory therapeutic procedures for pelvic-perineal pain in patients with endometriosis.

Moreover, as Endocare is not a pharmacological molecule but a digital therapy, it would not increase the consumption of pharmacological agents. An analgesic effect of Endocare lasting several hours on chronic pelvic-perineal pain associated with endometriosis is expected.

The effects of the treatment will be compare to a digital control also integrated in a virtual reality headset identical to the one distributing Endocare allowing to maintain the blindness to the patients and the investigator on the treatment received.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Endometriosis; Pelvic Pain
• Intervention / Treatment: Device: Endocare; Device: Digital control

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gironde
    • Bordeaux, Gironde, France, 33000
      • Recruiting
      • Clinique Tivoli Ducos
      • Contact: Benjamin Merlot, MD; Phone Number: +33650139254; Email: merlot.benjamin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women over 18 years of age with diagnosed endometriosis (histology, imaging, clinical symptomatology) and/or adenomyosis.

• Women with at least 2 consecutive days per month of endometriosis-related pelvic-perineal pain of moderate to severe intensity (NS ≥ 4):

  • Women without amenorrhea: pain around the onset of menstruation.
  • Women with amenorrhea: most intense pain of the month.

Exclusion Criteria:

• Pregnant or nursing women.
• Women participating, or who have participated, in a clinical interventional study within 30 days prior to inclusion.
• Women with severe visual, auditory or cognitive impairment, color blindness, photosensitivity, epilepsy or motion sickness.
• Women whose pain is occasional and not present at each menstrual period.
• Women who have previously received virtual reality treatments.
• Women under judicial protection, guardianship, curatorship, protective mandate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Endocare	Device: Endocare; Endocare will be administred through a virtual reality headseat used one to twice a day.
ACTIVE_COMPARATOR: Digital control	Device: Digital control; Digital control will be administred through a virtual reality headseat used one to twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity change	The mean change in pain intensity assessed by a numeric rating scale (pain intensity numerical scale) between the pre-treatment measurement and one hour after the use of Endocare treatment, compared to the digital control during the five days of treatment.The pain scale is a 11-point numeric scale (0=no pain; 10=unbearable pain).	Time points are before treatment (Time 0) and one hour after treatment (Time 1) during t five days (Day 1, Day 2, Day 3, Day 4, Day 5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity	Change in pain intensity assessed by numeric scale. The pain scale is a 11-point numeric scale (0=no pain; 10=unbearable pain).	at wake-up and bedtime during the 5 days of treat (Day 1 to Day 5)
Change in pain relief	Change in pain relief assessed by Likert pain relief scale. Its a 5-point categorical scale (0: no relief, 1: slight relief, 2: moderate relief, 3: lots of relief and 4: complete relief)	At 1 hour (Time 1), 2 hours (Time 2) and 3 hours (Time 3) after treatment during the 5 days of treatment (Day 1 to Day 5)
Weighted average change in pain intensity	Weighted average change (based on number of treatments Endocare or control uses) in pain intensity assessed by numeric scale. The pain scale is a 11-point numeric scale (0=no pain; 10=unbearable pain).	from pre-treatment (Time 0) to 2 hours (Time 2) and 3 hours (Time 3) post-treatment during the 5 days of treatment (Day 1 to Day 5)
Change in stress value	Change in stress assessed by Visual Analogue Scale (VAS). Visual Analogue Scale (VAS) consists of a small unmarked 100 mm ruler with ends labelled 'none' and 'as bad as possible'.	at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5)
Change in fatigue value	Change in stress assessed by Visual Analogue Scale (VAS) and fatigue assessed by Pichot Scale. The Pichot scale evaluates 8 fatigue items ranging from 0 to 4 (0: not at all; 1: a little; 2: moderately; 3: a lot; 4: extremely)	at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5)
Change in endometriosis-related quality of life	Change in endometriosis-related quality of life assessed by Endometriosis Health Profile (EHP-5). The EHP-5 consists of 11 items ranging from "never" to "always"	At inclusion visit Day 0 and at through study completion (Day 6), an average of one week
Assessment of the predictive value of dramatization and catastrophizing thoughts	Assessment of the predictive value of dramatization and catastrophizing thoughts assessed by Patient catastrophizing scale (PCS) coonsisting of 13 items ranging from 0 to 4 (0= not at all; 1= to a slight degree; 2= to a moderate degree; 3= to a great degree; 4 = all the time).	At the inclusion visit Day 0
Pain relief treatments	Number, frequency and dosage of pain relief treatments assessed by patient diary	during the five days of treatment (Day 1 to Day 5) at bedtime
Assessment of satisfaction	Assessment of satisfaction by Likert scale. It is a 7-point Likert scale (1: extremely dissatisfied, 2: very dissatisfied, 3: dissatisfied, 4: neutral, 5: satisfied, 6: very satisfied, 7: extremely satisfied).	through study completion (Day 6), an average of one week
Assessment of Clinical Global Impression of Improvement	Assessment of Clinical Global Impression of Improvement by CGI scale. It is a 7-point scale (1=very much improved; 7=very much worse)	through study completion (Day 6), an average of one week
Incidence of adverse events and treatment adherence	Incidence of adverse events and treatment adherence collected by patients diary and phone	during the five days of treatment (Day 1 to Day 5)

Collaborators and Investigators

• Sponsor: Lucine
• Collaborators: Biotrial

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 7, 2021
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (ACTUAL): December 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 4, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Endometriosis; Pelvic Pain
• Other Study ID Numbers: 2021-A02358-33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No