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

Study Overview
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Brief Summary
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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.

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

Conditions
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Endometriosis, Chronic Pain, Pelvic Pain

Intervention / Treatment
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* Device: Endocare
* Device: Digital control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endocare<br> | Device: Endocare<br>* Endocare will be administred through a virtual reality headseat used one to twice a day.<br>|
| Active Comparator: Digital control<br> | Device: Digital control<br>* Digital control will be administred through a virtual reality headseat used one to twice a day.<br>|

What is the study measuring?
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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) |