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Cortical Plasticity in a Complex Intervention for Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01321840
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : January 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Endometriosis Procedure: Specific Autoregulation Therapy (SART)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Investigation of Cortical Plasticity in a Complex Intervention for Endometriosis
Study Start Date : March 2010
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Brain function [ Time Frame: 12 weeks ]
    Changes in cortical thickness, functional connectivity and perfusion of brain areas related to the processing of pain and emotions.


Secondary Outcome Measures :
  1. Reduction of pain [ Time Frame: 12 weeks ]
    Reduction of pain by 50% or more (dichotomous).

  2. Pain scores [ Time Frame: 12 wks ]
    Changes (ordinal) in pain scores as assessed by the questionnaire of the German Society For The Study Of Pain (DGSS).

  3. Quality of life [ Time Frame: 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).

  4. Endometriosis-related symptoms [ Time Frame: 12 wks ]
    Normalization of menstruation, pelvic pain, dyspareunia, defecation pain as assessed by the Erlangen Endometriosis questionnaire.

  5. HRV (HF, LF, LF/HF) [ Time Frame: 12 wks ]
    heart rate variability parameters


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Florian Beissner, Dr. phil. nat., University of Jena
ClinicalTrials.gov Identifier: NCT01321840     History of Changes
Other Study ID Numbers: Jena-Endo-01
First Posted: March 24, 2011    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017

Keywords provided by Florian Beissner, University of Jena:
Endometriosis
pain
sart
autonomic nervous system
fMRI
perfusion
connectivity
hypnotherapy
traditional Chinese medicine

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female