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Trial record 1 of 2 for:    beissner
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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:
Technische Universität München
Information provided by (Responsible Party):
Florian Beissner, University of Jena

Tracking Information
First Submitted Date  ICMJE March 23, 2011
First Posted Date  ICMJE March 24, 2011
Last Update Posted Date January 6, 2017
Study Start Date  ICMJE March 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2011)
  • Reduction of pain [ Time Frame: 12 weeks ]
    Reduction of pain by 50% or more (dichotomous).
  • 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).
  • 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).
  • Endometriosis-related symptoms [ Time Frame: 12 wks ]
    Normalization of menstruation, pelvic pain, dyspareunia, defecation pain as assessed by the Erlangen Endometriosis questionnaire.
  • HRV (HF, LF, LF/HF) [ Time Frame: 12 wks ]
    heart rate variability parameters
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cortical Plasticity in a Complex Intervention for Endometriosis
Official Title  ICMJE Investigation of Cortical Plasticity in a Complex Intervention for Endometriosis
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Endometriosis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Treatment
    This group will be treated with SART.
    Intervention: Procedure: Specific Autoregulation Therapy (SART)
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2011)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01321840
Other Study ID Numbers  ICMJE Jena-Endo-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Florian Beissner, University of Jena
Study Sponsor  ICMJE University of Jena
Collaborators  ICMJE Technische Universität München
Investigators  ICMJE
Study Director: Florian Beissner, Dr.phil.nat. Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie, Jena
PRS Account University of Jena
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP