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.
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
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)
Parallel
Monoplace Hyperbaric Chamber (Class III medical device)
DeviceParticipants 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.
Change in pain symptoms on the NRS
Assessed on the numeric rating scale between 0 to 10, with 10 indicating the worst possible pain
Change in pain frequency
The change in pain frequency will be assessed on a 5-point Likert scale, where 1 is "never" and 5 is "always."
Change in opioid consumption
Collected as a categorical variable ("Are you taking 1) more, 2) same or 3) less compared to start of treatment?")
Participant Quality of Life on the EHP-30
The Endometriosis Health Profile-30 is a validated, high-sensitivity, 30-item endometriosis-specific assessment tool for capturing the impact of endometriosis on patient's lives.
Participant Quality of Life on the SF-36
The Quality of Life Short Form Survey-36 is a widely used tool to assess an individual's overall health-related quality of life.
Adherence to HBOT protocol
How many patients complete protocol (minimum 4 treatments per week with \>35 treatments)
Satisfaction assessed by a Patient Satisfaction Questionnaire
Subjective questionnaire completion at end of treatment inquiring about HBOT experience, barriers to and promoters of treatment
Cost of study completion
Cost of study completion on a per patient basis including research support, healthcare resource costs, and patient-related personal costs (transport, time from work)
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