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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
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The Brigham and Women's Pain Management Center is conducting a research study for chronic pelvic pain patients due to endometriosis. The study will assess the effect of electro-stimulation for the treatment of Chronic Pelvic Pain. You may be eligible if you have chronic pelvic pain due to endometriosis, are between the ages of 21- 64, and not taking opioid medication (such as morphine or oxycodone). The study will require two visits, each lasting about 2 hours. The study takes place at the Brigham & Women's Pain Management Center, 850 Boylston St., Chestnut Hill. Please contact Chrissie Cahalan at 617-732-9014 or ccahalan1@partners.org if interested.
The Brigham and Women's Pain Management Center is conducting a research study for chronic pelvic pain patients due to endometriosis. The study will assess the effect of electro-stimulation for the treatment of Chronic Pelvic Pain. You may be eligible if you have chronic pelvic pain due to endometriosis, are between the ages of 21- 64, and not taking opioid medication (such as morphine or oxycodone). The study will require two visits, each lasting about 2 hours. The study takes place at the Brigham & Women's Pain Management Center, 850 Boylston St., Chestnut Hill. Please contact Chrissie Cahalan at 617-732-9014 or ccahalan1@partners.org if interested.
Vitaly Napadow, Ph.D., Lic.Ac. Assistant Professor Dept. of Radiology, Massachusetts General Hospital, Harvard Medical School
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real Stimulation | Experimental | Ear stimulation at specific points should work by stimulating a nerve called the vagus nerve. Previous research has shown that stimulating this nerve can help patients feel less pain. |
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| Sham | Sham Comparator | The sham treatment will use the same equipment as the real treatment, but the participant will not receive any real stimulation to the ear. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real stimulation VS Sham | Behavioral | Ear stimulation at specific points should work by stimulating a nerve called the vagus nerve. Previous research has shown that stimulating this nerve can help patients feel less pain. During any testing session, participants may receive either the real ear stimulation or a sham (placebo) treatment. The sham treatment will use the same equipment as the real treatment, but will not deliver any real stimulation to the ear. We use placebo/sham procedures in research to make sure that the study results are related to the study procedure, and not to other reasons. |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize analgesia following verum and sham RAVANS treatment in Endometriosis patients with and without psychiatric co-morbidity. | This will be done by comparing the quantitative sensory testing between the real and sham vagus nerve stimulation sessions. | 2-3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vitaly Napadow, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Chestnut Hill | Massachusetts | 02467 | United States |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| D000091662 | Genital Diseases |