Endometriosis
Conditions
Keywords
Endometriosis, pain, sart, autonomic nervous system, fMRI, perfusion, connectivity, hypnotherapy, traditional Chinese medicine
Brief summary
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.
Interventions
PROCEDURESpecific 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.
Sponsors
Technical University of Munich
University of Jena
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain function | 12 weeks | Changes in cortical thickness, functional connectivity and perfusion of brain areas related to the processing of pain and emotions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of pain | 12 weeks | Reduction of pain by 50% or more (dichotomous). |
| Pain scores | 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 | 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 | 12 wks | Normalization of menstruation, pelvic pain, dyspareunia, defecation pain as assessed by the Erlangen Endometriosis questionnaire. |
| HRV (HF, LF, LF/HF) | 12 wks | heart rate variability parameters |
Countries
Germany
Outcome results
None listed