Cortical Plasticity in a Complex Intervention for Endometriosis

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014