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Is Repetitive Transcranial Magnetic Stimulation Effective in Reducing Endometriosis-associated Pain

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 1, 2024 to Apr 12, 2024
    • Site details revised
    v3
  2. Minor Eligibility criteria shortened, about 22 words
    • Secondary endpoints: details revised at 1 of 29 entries
    • Study description shortened, about 16 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06333353
Lead Sponsor University of Ottawa
Conditions
(from sponsor)
Endometriosis, Pain
Related terms Endometriosis, Pain
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov