Cortical Plasticity in a Complex Intervention for Endometriosis
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|ClinicalTrials.gov Identifier: NCT01321840|
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : January 6, 2017
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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.
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis||Procedure: Specific Autoregulation Therapy (SART)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Investigation of Cortical Plasticity in a Complex Intervention for Endometriosis|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
This group will be treated with SART.
Procedure: Specific Autoregulation Therapy (SART)
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.
No Intervention: No treatment
This group will not be treated with SART but will regularly be examined by a gynecologist to detect sudden aggravation of the disease.
- Brain function [ Time Frame: 12 weeks ]Changes in cortical thickness, functional connectivity and perfusion of brain areas related to the processing of pain and emotions.
- Reduction of pain [ Time Frame: 12 weeks ]Reduction of pain by 50% or more (dichotomous).
- Pain scores [ Time Frame: 12 wks ]Changes (ordinal) in pain scores as assessed by the questionnaire of the German Society For The Study Of Pain (DGSS).
- Quality of life [ Time Frame: 12 wks ]Changes (ordinal) in the quality of life score as assessed by the questionnaire of the German Society For The Study Of Pain (DGSS).
- Endometriosis-related symptoms [ Time Frame: 12 wks ]Normalization of menstruation, pelvic pain, dyspareunia, defecation pain as assessed by the Erlangen Endometriosis questionnaire.
- HRV (HF, LF, LF/HF) [ Time Frame: 12 wks ]heart rate variability parameters
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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
- alcohol addiction, drug addiction
- diseases and other criteria, preventing an MRI examination:
- neurostimulator or drug pump
- metal parts in the body (implants, splinters, etc.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321840
|Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie|
|Jena, Germany, 07743|
|Frauenklinik der Technischen Universität München|
|München, Germany, 81675|
|Study Director:||Florian Beissner, Dr.phil.nat.||Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie, Jena|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Florian Beissner, Dr. phil. nat., University of Jena|
|Other Study ID Numbers:||
|First Posted:||March 24, 2011 Key Record Dates|
|Last Update Posted:||January 6, 2017|
|Last Verified:||January 2017|
autonomic nervous system
traditional Chinese medicine
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications