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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A01371-48 | Other Identifier | 2015-A01371-48 |
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Endometriosis is associated with different types of pain (acute, chronic, excess nociception, neuropathic) generated by different mechanisms in the nervous system. The rTMS could provide significant analgesia for refractory endometriosis pain.
The aim of the study is to evaluate the feasibility of transcranial magnetic stimulation (rTMS) for analgesia on chronic refractory endometriosis pain.
The first step consists of the inclusion of 12 patients followed by the filling by each patient of the RedCap software of five simple numerical scales for 4 weeks . Realization of a brain and medullary MRI to allow neuronavigation. Realization of 5 sessions of rTMS in 5 days during the first week then evaluation (physical examination, questionnaires) in consultation on post-stimulation. Then followed for 28 days in total through self-assessment of pain that will be filled daily on REDCap and last consultation on D28 for further evaluation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic refractory endometriosis pain | Experimental | The aim of the study is to evaluate the feasibility of transcranial magnetic stimulation (rTMS) for analgesia on chronic refractory endometriosis pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive transcranial magnetic stimulation | Device | Realization of a brain and medullary MRI to allow neuronavigation. Realization of 5 sessions of rTMS in 5 days during the first week then evaluation (physical examination, questionnaires) in consultation on post-stimulation. Then followed for 28 days in total through self-assessment of pain that will be filled daily on REDCap and last consultation on D28 for further evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients tolerant 5 sessions of stimulation and with no increase in pain | The feasibility of rTMS treatment was defined if 7 patients or more over 12 tolerate the 5 sessions of stimulation showed no increase in pain | at day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain between the mean pain evaluated before inclusion | thanks to the visual analogue scale traded between 0 and 100 | at day 8 |
| Endometriosis Health Profile Questionnaire (EPH-30); | Variation in scores of questionnaires before and after stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas BOURDEL, PH | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | Auvergne | 63003 | France |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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All participants receive the same intervention throughout the protocol
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Open
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| at day 8 |
| Brief Pain Inventory (BPI): digital | Variation in scores of questionnaires before and after stimulation | at day 8 |
| Beck Questionnaire (Depression) | Variation in scores of questionnaires before and after stimulation | at day 8 |
| STAI of Anxiety Scale; Scale of alexythymie of Toronto | Variation in scores of questionnaires before and after stimulation | at day 8 |
| Catastrophizing Pain Scale (personality) | Variation in scores of questionnaires before and after stimulation | at day 8 |
| Quality of Life Questionnaire SF-36 | Variation in scores of questionnaires before and after stimulation | at day 8 |
| Migraine criteria (ICHD3) | Variation in scores of questionnaires before and after stimulation | at day 8 |
| Gastrointestinal quality of Life Index (GICLI) | Variation in scores of questionnaires before and after stimulation | at day 8 |
| D000091662 | Genital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |