Cortical Plasticity in a Complex Intervention for Endometriosis

University of Jena60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Endometriosis

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie

Jena, Germany

Frauenklinik der Technischen Universität München

München, Germany

Outcomes

Primary Outcomes

Brain function

Changes in cortical thickness, functional connectivity and perfusion of brain areas related to the processing of pain and emotions.

Time frame: 12 weeks

Secondary Outcomes

Reduction of pain

Reduction of pain by 50% or more (dichotomous).

Time frame: 12 weeks

Pain scores

Changes (ordinal) in pain scores as assessed by the questionnaire of the German Society For The Study Of Pain (DGSS).

Time frame: 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).

Time frame: 12 wks

Endometriosis-related symptoms

Normalization of menstruation, pelvic pain, dyspareunia, defecation pain as assessed by the Erlangen Endometriosis questionnaire.

Time frame: 12 wks

HRV (HF, LF, LF/HF)

heart rate variability parameters

Time frame: 12 wks