Cortical Plasticity in a Complex Intervention for Endometriosis
This study has been completed.
Sponsor:
University of Jena
Collaborator:
Technische Universität München
Information provided by (Responsible Party):
Florian Beissner, University of Jena
ClinicalTrials.gov Identifier:
NCT01321840
First received: March 23, 2011
Last updated: May 19, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Endometriosis |
Procedure: Specific Autoregulation Therapy (SART) |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Jena:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
| Enrollment: | 60 |
| Study Start Date: | March 2010 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321840
Locations
| Germany | |
| Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie | |
| Jena, Germany, 07743 | |
| Frauenklinik der Technischen Universität München | |
| München, Germany, 81675 | |
Sponsors and Collaborators
University of Jena
Technische Universität München
Investigators
| Study Director: | Florian Beissner, Dr.phil.nat. | Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie, Jena |
More Information
No publications provided
| Responsible Party: | Florian Beissner, Dr. phil. nat., University of Jena |
| ClinicalTrials.gov Identifier: | NCT01321840 History of Changes |
| Other Study ID Numbers: | Jena-Endo-01 |
| Study First Received: | March 23, 2011 |
| Last Updated: | May 19, 2013 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Jena:
|
Endometriosis pain sart autonomic nervous system fMRI |
perfusion connectivity hypnotherapy traditional Chinese medicine |
Additional relevant MeSH terms:
|
Endometriosis Genital Diseases, Female |
ClinicalTrials.gov processed this record on June 18, 2013