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| Name | Class |
|---|---|
| Technical University of Munich | OTHER |
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The aim of the study is to test, if patients suffering from Endometriosis show changes in their brain function, when being treated with SART (Systemic Autoregulation Therapy), a complex intervention consisting of interventions from Traditional Chinese Medicine (TCM) and Western Hypnotherapy. Functional and structural brain changes are assessed using Magnetic Resonance Imaging data which are analyzed by means of voxel-based morphometry (VBM), connectivity and perfusion analysis. A third outcome measure are changes of patients' heart rate variability, indicating the activity of their autonomic nervous system.
With a number of questionnaires, changes in dysmenorrhea, chronic pelvic pain, menstruation regularity, dyspareunia, defecation pain, and quality of life are assessed during the SART treatment.
During the treatment, we expect to see changes in cortical thickness, functional connectivity and perfusion of pain-related areas of the cortex, that correlate with the changes in heart rate variability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | This group will be treated with SART. |
|
| No treatment | No Intervention | This group will not be treated with SART but will regularly be examined by a gynecologist to detect sudden aggravation of the disease. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specific Autoregulation Therapy (SART) | Procedure | Complex intervention involving acupuncture and hypnotherapeutic techniques after an extensive diagnosis using chinese medical concepts. Patients will receive a maximum of 10 treatments, which are delivered weekly. |
| Measure | Description | Time Frame |
|---|---|---|
| Brain function | Changes in cortical thickness, functional connectivity and perfusion of brain areas related to the processing of pain and emotions. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of pain | Reduction of pain by 50% or more (dichotomous). | 12 weeks |
| Pain scores | Changes (ordinal) in pain scores as assessed by the questionnaire of the German Society For The Study Of Pain (DGSS). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florian Beissner, Dr.phil.nat. | Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie, Jena | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie | Jena | 07743 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27741200 | Result | Meissner K, Schweizer-Arau A, Limmer A, Preibisch C, Popovici RM, Lange I, de Oriol B, Beissner F. Psychotherapy With Somatosensory Stimulation for Endometriosis-Associated Pain: A Randomized Controlled Trial. Obstet Gynecol. 2016 Nov;128(5):1134-1142. doi: 10.1097/AOG.0000000000001691. | |
| 28258747 | Derived | Beissner F, Preibisch C, Schweizer-Arau A, Popovici RM, Meissner K. Psychotherapy With Somatosensory Stimulation for Endometriosis-Associated Pain: The Role of the Anterior Hippocampus. Biol Psychiatry. 2018 Nov 15;84(10):734-742. doi: 10.1016/j.biopsych.2017.01.006. Epub 2017 Jan 16. |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D010146 | 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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| 12 wks |
| Quality of life | Changes (ordinal) in the quality of life score as assessed by the questionnaire of the German Society For The Study Of Pain (DGSS). | 12 wks |
| Endometriosis-related symptoms | Normalization of menstruation, pelvic pain, dyspareunia, defecation pain as assessed by the Erlangen Endometriosis questionnaire. | 12 wks |
| HRV (HF, LF, LF/HF) | heart rate variability parameters | 12 wks |
| Frauenklinik der Technischen Universität München |
| München |
| 81675 |
| Germany |
| D000091662 | Genital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |