Hyperbaric Oxygen Therapy for Pain from Endometriosis
The HEROES Trial: Hyperbaric Oxygen Therapy for Endometriosis-Related Pain: A Prospective Randomized Study
This study is testing if Hyperbaric Oxygen Therapy can help women with endometriosis who have been in pain for a long time feel better while they wait for surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06579040 on ClinicalTrials.gov |
What this trial studies
This trial investigates the use of Hyperbaric Oxygen Therapy (HBOT) to alleviate pelvic pain associated with endometriosis, a condition affecting approximately 10% of women. The study aims to provide an alternative treatment option for patients who have been suffering from refractory pain for over six months and are on a waitlist for surgical intervention. By utilizing a monoplace hyperbaric chamber, the therapy seeks to reduce inflammation and promote healing in affected tissues. The trial will assess the effectiveness of HBOT in improving pain levels and overall quality of life for participants.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with refractory pelvic pain due to endometriosis for more than six months.
Not a fit: Patients with chronic pain from conditions unrelated to endometriosis or those medically unfit for hyperbaric treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide significant pain relief and improve the quality of life for women suffering from endometriosis-related pain.
How similar studies have performed: While the use of HBOT for endometriosis is a novel approach, preliminary research suggests potential benefits in reducing inflammation, though further studies are needed to confirm efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Fahad Alam, MD
- Email: fahad.alam@sunnybrook.ca
- Phone: 416-480-4864
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.