Chronic Pain, Endometriosis, Pelvic Pain
Conditions
Brief summary
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.
Interventions
DEVICEEndocare
Endocare will be administred through a virtual reality headseat used one to twice a day.
DEVICEDigital control
Digital control will be administred through a virtual reality headseat used one to twice a day.
Sponsors
Biotrial
Lucine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity change | 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) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain 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) | 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) |
| Weighted average change in pain intensity | 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) | 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). |
| Change in stress value | at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5) | 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'. |
| Change in fatigue value | at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5) | 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) |
| Change in endometriosis-related quality of life | At inclusion visit Day 0 and at through study completion (Day 6), an average of one week | 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 |
| Change in pain intensity | at wake-up and bedtime during the 5 days of treat (Day 1 to Day 5) | Change in pain intensity assessed by numeric scale. The pain scale is a 11-point numeric scale (0=no pain; 10=unbearable pain). |
| Pain relief treatments | during the five days of treatment (Day 1 to Day 5) at bedtime | Number, frequency and dosage of pain relief treatments assessed by patient diary |
| Assessment of satisfaction | through study completion (Day 6), an average of one week | 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). |
| Assessment of Clinical Global Impression of Improvement | through study completion (Day 6), an average of one week | Assessment of Clinical Global Impression of Improvement by CGI scale. It is a 7-point scale (1=very much improved; 7=very much worse) |
| Incidence of adverse events and treatment adherence | during the five days of treatment (Day 1 to Day 5) | Incidence of adverse events and treatment adherence collected by patients diary and phone |
| Assessment of the predictive value of dramatization and catastrophizing thoughts | At the inclusion visit Day 0 | 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). |
Countries
France
Outcome results
None listed