Clinical trial NCT01321840: Cortical Plasticity in a Complex Intervention for Endometriosis
Official title: Investigation of Cortical Plasticity in a Complex Intervention for Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Keywords: Endometriosis
pain
sart
autonomic nervous system
fMRI
perfusion
connectivity
hypnotherapy
traditional Chinese medicine
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
First posted: 2011-03-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Brain function
timeFrame: 12 weeks
Secondary outcomes:
measure: Reduction of pain
timeFrame: 12 weeks
measure: Pain scores
timeFrame: 12 wks
measure: Quality of life
timeFrame: 12 wks
measure: Endometriosis-related symptoms
timeFrame: 12 wks
measure: HRV (HF, LF, LF/HF)
timeFrame: 12 wks
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie
city: München
country: Germany
facility: Frauenklinik der Technischen Universität München
Study officials:
affiliation: Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie, Jena
name: Florian Beissner, Dr.phil.nat.
role: STUDY_DIRECTOR
References:
citation: Meissner K, Schweizer-Arau A, Limmer A, Preibisch C, Popovici RM, Lange I, de Oriol B, Beissner F. Psychotherapy With Somatosensory Stimulation for Endometriosis-Associated Pain: A Randomized Controlled Trial. Obstet Gynecol. 2016 Nov;128(5):1134-1142. doi: 10.1097/AOG.0000000000001691.
citation: Beissner F, Preibisch C, Schweizer-Arau A, Popovici RM, Meissner K. Psychotherapy With Somatosensory Stimulation for Endometriosis-Associated Pain: The Role of the Anterior Hippocampus. Biol Psychiatry. 2018 Nov 15;84(10):734-742. doi: 10.1016/j.biopsych.2017.01.006. Epub 2017 Jan 16.