RecruitingNot ApplicableNCT06579040

The HEROES Trial: Hyperbaric Oxygen Therapy for Endometriosis-Related Pain

The HEROES Trial: Hyperbaric Oxygen Therapy for Endometriosis-Related Pain: A Prospective Randomized Study


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

64 participants

Start Date

Apr 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Endometriosis, is a condition where tissue from the uterus, called endometrium, grows outside of the uterus. This effects up to 10% of women, and can lead to long-lasting, moderate to severe pelvic pain, infertility and other symptoms. This can affect a woman's quality of life (including increased risk of depression and anxiety) and is associated with increased healthcare costs. Current treatments are often limited by serious side effects, and many women resort to surgery. Surgery is also associated with complications and there are long wait times for procedures, sometimes over 3 years. This means that many women continue to suffer from symptoms while they wait for surgery. Therefore, new effective treatments for endometriosis pain are needed. New research suggests that inflammation and stress caused by lack of oxygen in the affected areas may cause endometriosis. Hyperbaric Oxygen Therapy (HBOT), where patients are placed in a small chamber with higher than normal levels of oxygen, suppresses inflammation and promotes tissue healing. Because inflammation is central to this condition, HBOT has emerged as a potential treatment. In this study, the investigators will test if HBOT, in addition to the standard treatments, is more effective at treating endometriosis pain than the standard treatments alone.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Age ≥ 18 years old
  • Patients having refractory pelvic pain (NRS≥4) secondary to endometriosis for \>6 months
  • May or may not be on traditional multi-modal treatment (pharmacological and/or non-pharmacological)
  • On waitlist for surgical treatment

Exclusion Criteria3

  • Patients with chronic pain resulting from disease processes unrelated to the pathophysiology of endometriosis-related symptoms (e.g. irritable bowel syndrome, migraine headache, fibromyalgia, chronic low back pain, and musculoskeletal injuries)
  • Contraindications/medically unfit to receive hyperbaric treatments at an outpatient facility (e.g. pneumothorax, in-patients, requiring infusions to maintain hemodynamics, active and unstable coronary disease)
  • Unlikely to comply with follow-up assessments (e.g. no fixed address, plans to move out of town)

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Interventions

DEVICEMonoplace Hyperbaric Chamber (Class III medical device)

Participants in the intervention group will be triaged to the closest hyperbaric facility to their address and treated with 40 HBOTs (2 ATM for 90 mins, scheduled daily from Monday to Friday). As HBOT is not a service currently offered at Sunnybrook Hospital, all HBOT treatments will be provided at three collaborating outpatient facilities, Halton Hyperbaric Unit, Restore Hyperbaric Oxygen \& Medical Centre (CPSO-certified Level-II OHP), and Rouge Valley Hyperbaric Medical Centre. All three facilities have the exact same hyperbaric chambers, run by anesthesiologists with advanced training, thus treatments will be identical at all sites.


Locations(1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT06579040


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