Cortical Plasticity in a Complex Intervention for Endometriosis

Study Overview
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Brief Summary
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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.

Official Title
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Investigation of Cortical Plasticity in a Complex Intervention for Endometriosis

Conditions
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Endometriosis

Intervention / Treatment
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* Procedure: Specific Autoregulation Therapy (SART)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years old clinically or histologically ensured diagnosis of Endometriosis preoperative and postoperative recurring ailments related to Endometriosis no hormone therapy (GnRH analogues, contraceptives) sufficient understanding of the German or English language persisting pain during menstruation (also in between) voluntary participation after information on the possible benefits and risks of the examination and intervention written informed consent Exclusion Criteria: alcohol addiction, drug addiction pregnancy diseases and other criteria, preventing an MRI examination: pacemaker neurostimulator or drug pump metal parts in the body (implants, splinters, etc.) claustrophobia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>This group will be treated with SART. | Procedure: Specific Autoregulation Therapy (SART)<br>* 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.<br>|
| No Intervention: No treatment<br>This group will not be treated with SART but will regularly be examined by a gynecologist to detect sudden aggravation of the disease. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis, pain, sart, autonomic nervous system, fMRI, perfusion, connectivity, hypnotherapy, traditional Chinese medicine