protocolSection identificationModule nctId: NCT06333353, orgStudyIdInfo id: H-06-23-9278, briefTitle: Is Repetitive Transcranial Magnetic Stimulation Effective in Reducing Endometriosis-associated Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2027-05-20, completionDateStruct date: 2027-06-20, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Ottawa, class: OTHER, descriptionModule briefSummary: 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 EAP3. to determine if any improvements in pain observed 30 days after an rTMS intervention are retained 6 months later4. 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., conditionsModule conditions: Endometriosis, conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: All participants, care providers, investigators and outcome assessors will remain blinded to real/sham intervention. The outcomes assessor and the investigator will remain blinded to intervention duration., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 152, type: ESTIMATED, armsInterventionsModule interventions name: Real RepetitiveTranscranial Magnetic Stimulation 5 sessions, interventions name: Sham RepetitiveTranscranial Magnetic Stimulation 5 sessions, interventions name: Real RepetitiveTranscranial Magnetic Stimulation 10 sessions, interventions name: Sham RepetitiveTranscranial Magnetic Stimulation 10 sessions, outcomesModule primaryOutcomes measure: Numeric rating scale (NRS) used to record daily pain over 30 days, primaryOutcomes measure: Numeric rating scale(NRS) used to record daily pain over 30 days, primaryOutcomes measure: Patient Global Impression of Change (PGIC) in pain, primaryOutcomes measure: Patient Global Impression of Change (PGIC) in pain, primaryOutcomes measure: Patient Global Impression of Change (PGIC) in pain, secondaryOutcomes measure: The Beck Depression Inventory (BDI-II), secondaryOutcomes measure: The Beck Depression Inventory (BDI-II), secondaryOutcomes measure: The Beck Depression Inventory (BDI-II), secondaryOutcomes measure: The State-Trait Anxiety Inventory (STAI), secondaryOutcomes measure: The Pain Catastrophizing Scale, secondaryOutcomes measure: The Central sensitization index, secondaryOutcomes measure: Female Sexual Distress Scale (FSDS), secondaryOutcomes measure: Adherence to the intervention protocol, secondaryOutcomes measure: Pressure pain threshold (PPThresh), secondaryOutcomes measure: Pressure pain threshold (PPThresh), secondaryOutcomes measure: Pressure Pain Tolerance (PPTol), secondaryOutcomes measure: Pressure Pain Tolerance (PPTol), secondaryOutcomes measure: Perceived pain intensity (PPI), secondaryOutcomes measure: Perceived pain intensity (PPI), secondaryOutcomes measure: Temporal summation (TS) of pain, secondaryOutcomes measure: Temporal summation (TS) of pain, secondaryOutcomes measure: Pain rating during the tampon test, secondaryOutcomes measure: Pain rating during the tampon test, secondaryOutcomes measure: Conditioned pain modulation (CPM), secondaryOutcomes measure: Conditioned pain modulation (CPM), secondaryOutcomes measure: The Brief Pain Inventory, secondaryOutcomes measure: The Brief Pain Inventory, secondaryOutcomes measure: The Brief Pain Inventory, secondaryOutcomes measure: The Endometriosis Health Profile Questionnaire (EPH-30), secondaryOutcomes measure: The Endometriosis Health Profile Questionnaire (EPH-30), secondaryOutcomes measure: The Endometriosis Health Profile Questionnaire (EPH-30), secondaryOutcomes measure: Patient satisfaction with treatment (PST), secondaryOutcomes measure: Patient satisfaction with treatment (PST), secondaryOutcomes measure: Patient satisfaction with treatment (PST), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: McLean Function Measurement Lab, status: RECRUITING, city: Ottawa, state: Ontario, zip: K1S1S2, country: Canada, contacts name: Anne-Marie MacDonald, MSc, role: CONTACT, phone: 613-562-5800, phoneExt: 4102, email: mfmlab@uottawa.ca, contacts name: Linda McLean, PhD, role: CONTACT, phone: 613-562-5800, phoneExt: 4102, email: lmclea2@uottawa.ca, contacts name: Linda McLean, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.41117, lon: -75.69812, hasResults: False