Cortical Plasticity in a Complex Intervention for Endometriosis
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Investigation of Cortical Plasticity in a Complex Intervention for Endometriosis|
- Brain function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Reduction of pain by 50% or more (dichotomous).
- Pain scores [ Time Frame: 12 wks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Normalization of menstruation, pelvic pain, dyspareunia, defecation pain as assessed by the Erlangen Endometriosis questionnaire.
- HRV (HF, LF, LF/HF) [ Time Frame: 12 wks ] [ Designated as safety issue: No ]heart rate variability parameters
|Study Start Date:||March 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|