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

NCT05172492 | Unknown

• 1 other identifier: 2021-A02358-33
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Chronic Pain; Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in pain intensity

  at wake-up and bedtime during the 5 days of treat (Day 1 to Day 5)

• 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)

• 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)

• Change in stress value

  at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5)

• Change in fatigue value

  at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5)

Study Arms (2)

Endocare

EXPERIMENTAL

Device: Endocare

Digital control

ACTIVE COMPARATOR

Device: Digital control

Interventions

Endocare DEVICE

Endocare will be administred through a virtual reality headseat used one to twice a day.

Endocare

Digital control DEVICE

Digital control will be administred through a virtual reality headseat used one to twice a day.

Digital control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or nursing women.
• 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.

Sponsors & Collaborators

• Lucine: lead
• Biotrial: collaborator

Study Sites (1)

Clinique Tivoli Ducos

Bordeaux, Gironde, 33000, France

RECRUITING

Related Publications (1)

• Merlot B, Elie V, Perigord A, Husson Z, Jubert A, Chanavaz-Lacheray I, Dennis T, Cotty-Eslous M, Roman H. Pain Reduction With an Immersive Digital Therapeutic in Women Living With Endometriosis-Related Pelvic Pain: At-Home Self-Administered Randomized Controlled Trial. J Med Internet Res. 2023 Jun 28;25:e47869. doi: 10.2196/47869.

  PMID: 37260160 DERIVED

MeSH Terms

Conditions

Endometriosis; Chronic Pain; Pelvic Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 29, 2021
• Study Start: December 7, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)