Recruiting

Hyperbaric Oxygen Therapy

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT06579040

Conditions

Endometriosis-related Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Monoplace Hyperbaric Chamber (Class III medical device)

Study Details

Brief 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.

Conditions

Endometriosis-related Pain

Study ID

NCT06579040

Start date

Apr 8, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Group I (Control)

Standard multi-modal therapy

experimental: Group II (Intervention)

Standard multi-modal therapy + 40 HBOT treatments (2 ATM for 90 mins daily, 5 days a week)

Interventions

Monoplace 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.

Primary outcome measure

  • Change in pain symptoms on the NRS [ Time Frame: At baseline, weekly for the first 8 weeks after enrollment, then at 3/4/5/6 month follow ups ]

Central Contacts and Locations

Central contacts

Fahad Alam, MD

416-480-4864fahad.alam@sunnybrook.ca

Grace Liu, MD

416-480-6100grace.liu@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • Endometriosis
  • Endometriosis-related Pain
  • Hyperbaric Oxygen Therapy
  • HBOT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-04-15.