Clinical trial NCT05172492: Endocare for Pelvic-perineal Pain Related to Endometriosis Used at Home
Official title: Efficacy of Endocare Treatment at Home on Pain in Women With Chronic Pelvic-perineal Pain Related to Endometriosis. EndoHome.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis
Chronic Pain
Pelvic Pain
Lead sponsor: Lucine
Sponsor class: INDUSTRY
Collaborators: name: Biotrial
First posted: 2021-12-29
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity change
timeFrame: 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 outcomes:
measure: Change in pain intensity
timeFrame: at wake-up and bedtime during the 5 days of treat (Day 1 to Day 5)
measure: Change in pain relief
timeFrame: 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)
measure: Weighted average change in pain intensity
timeFrame: 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)
measure: Change in stress value
timeFrame: at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5)
measure: Change in fatigue value
timeFrame: at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5)
measure: Change in endometriosis-related quality of life
timeFrame: At inclusion visit Day 0 and at through study completion (Day 6), an average of one week
measure: Assessment of the predictive value of dramatization and catastrophizing thoughts
timeFrame: At the inclusion visit Day 0
measure: Pain relief treatments
timeFrame: during the five days of treatment (Day 1 to Day 5) at bedtime
measure: Assessment of satisfaction
timeFrame: through study completion (Day 6), an average of one week
measure: Assessment of Clinical Global Impression of Improvement
timeFrame: through study completion (Day 6), an average of one week
measure: Incidence of adverse events and treatment adherence
timeFrame: during the five days of treatment (Day 1 to Day 5)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinique Tivoli Ducos
state: Gironde
Study officials:
References: