Cortical Plasticity in a Complex Intervention for Endometriosis

Not Applicable

Completed

• Conditions: Endometriosis
• Interventions: Procedure: Specific Autoregulation Therapy (SART)

• Registration Number: NCT01321840
• Lead Sponsor: University of Jena

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-23
• Study First Posted: 2011-03-24
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Specific Autoregulation Therapy (SART)	This group will be treated with SART.

Primary Outcome Measures

Name	Time	Method
Brain function	12 weeks	Changes in cortical thickness, functional connectivity and perfusion of brain areas related to the processing of pain and emotions.

Secondary Outcome Measures

Name	Time	Method
Reduction of pain	12 weeks	Reduction of pain by 50% or more (dichotomous).
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).
Pain scores	12 wks	Changes (ordinal) in pain scores 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

Trial Locations

Locations (2)

Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie; 🇩🇪 Jena, Germany

Frauenklinik der Technischen Universität München; 🇩🇪 München, Germany