NCT06333353Recruiting
Is Repetitive Transcranial Magnetic Stimulation Effective in Reducing Endometriosis-associated Pain
Is Repetitive Transcranial Magnetic Stimulation Effective in Reducing Endometriosis-associated Pain: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 15 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this research is to improve pain outcomes for the over 500K Canadian women, girls and gender-diverse individuals who are newly diagnosed with endometriosis each year. Chronic pain that persists after interventions for endometriosis is a huge problem. There is some evidence that endometriosis-associated pain (EAP) is, at least to some extent, associated with changes in pain physiology, particularly central sensitization of pain. There is currently no effective evidence-informed intervention that addresses EAP. Yet a recent feasibility trial on a repetitive transcranial magnetic stimulation (rTMS) intervention demonstrated promising results compared to a sham intervention for reducing pain in a sample with EAP. The objectives of this trial are: 1. to evaluate the effectiveness of an rTMS intervention for pain reduction among those with recalcitrant post-operative EAP, 2. to inform on the utility of a long (10 session) vs short (5 session) protocol for pain reduction among those with recalcitrant post-operative EAP 3. to determine if any improvements in pain observed 30 days after an rTMS intervention are retained 6 months later 4. to identify physical and psychosocial mediators that impact the successful reduction of pain among patients with EAP treated using rTMS. 5. to describe patients' perceptions of and satisfaction with rTMS as an intervention for EAP.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 152 (estimated)
- First submitted
- 20 Mar 2024
- Start date
- 12 Apr 2024
- Primary completion date
- 20 May 2027
- Lead sponsor
- University of Ottawa
- Diseases
- Endometriosis
- NCT number
- NCT06333353
What you commit to
- Study type: Interventional
- Planned participants: 152
- From 12 Apr 2024 to the primary completion date, 20 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Contra-indications to rTMS (e.g., metal/implants around the head/neck, pacemaker), history of epilepsy (history of seizures) in the family
- Pain symptoms initiated by other known causes (e.g., infections, thyroid disease, autoimmune diseases, gastrointestinal disease)
Other
- Experience a more severe, extra-pelvic pain than that associated with endometriosis
- Pregnancy
Who the study is looking for
- -self-reported endometriosis-associated pain (\> 3 in the numeric rating scale, 0-10) that has persisted following medical or surgical intervention,
Age in the registry: 18 years to 60 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McLean Function Measurement Lab Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.