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Cortical Plasticity in a Complex Intervention for Endometriosis

Primary Purpose

Endometriosis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Specific Autoregulation Therapy (SART)
Sponsored by
University of Jena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Endometriosis focused on measuring Endometriosis, pain, sart, autonomic nervous system, fMRI, perfusion, connectivity, hypnotherapy, traditional Chinese medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie
  • Frauenklinik der Technischen Universität München

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

No treatment

Arm Description

This group will be treated with SART.

This group will not be treated with SART but will regularly be examined by a gynecologist to detect sudden aggravation of the disease.

Outcomes

Primary Outcome Measures

Brain function
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
Reduction of pain by 50% or more (dichotomous).
Pain scores
Changes (ordinal) in pain scores as assessed by the questionnaire of the German Society For The Study Of Pain (DGSS).
Quality of life
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
Normalization of menstruation, pelvic pain, dyspareunia, defecation pain as assessed by the Erlangen Endometriosis questionnaire.
HRV (HF, LF, LF/HF)
heart rate variability parameters

Full Information

First Posted
March 23, 2011
Last Updated
January 5, 2017
Sponsor
University of Jena
Collaborators
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT01321840
Brief Title
Cortical Plasticity in a Complex Intervention for Endometriosis
Official Title
Investigation of Cortical Plasticity in a Complex Intervention for Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena
Collaborators
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Endometriosis, pain, sart, autonomic nervous system, fMRI, perfusion, connectivity, hypnotherapy, traditional Chinese medicine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
This group will be treated with SART.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
This group will not be treated with SART but will regularly be examined by a gynecologist to detect sudden aggravation of the disease.
Intervention Type
Procedure
Intervention Name(s)
Specific Autoregulation Therapy (SART)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brain function
Description
Changes in cortical thickness, functional connectivity and perfusion of brain areas related to the processing of pain and emotions.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Reduction of pain
Description
Reduction of pain by 50% or more (dichotomous).
Time Frame
12 weeks
Title
Pain scores
Description
Changes (ordinal) in pain scores as assessed by the questionnaire of the German Society For The Study Of Pain (DGSS).
Time Frame
12 wks
Title
Quality of life
Description
Changes (ordinal) in the quality of life score as assessed by the questionnaire of the German Society For The Study Of Pain (DGSS).
Time Frame
12 wks
Title
Endometriosis-related symptoms
Description
Normalization of menstruation, pelvic pain, dyspareunia, defecation pain as assessed by the Erlangen Endometriosis questionnaire.
Time Frame
12 wks
Title
HRV (HF, LF, LF/HF)
Description
heart rate variability parameters
Time Frame
12 wks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florian Beissner, Dr.phil.nat.
Organizational Affiliation
Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie, Jena
Official's Role
Study Director
Facility Information:
Facility Name
Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Frauenklinik der Technischen Universität München
City
München
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
27741200
Citation
Meissner K, Schweizer-Arau A, Limmer A, Preibisch C, Popovici RM, Lange I, de Oriol B, Beissner F. Psychotherapy With Somatosensory Stimulation for Endometriosis-Associated Pain: A Randomized Controlled Trial. Obstet Gynecol. 2016 Nov;128(5):1134-1142. doi: 10.1097/AOG.0000000000001691.
Results Reference
result
PubMed Identifier
28258747
Citation
Beissner F, Preibisch C, Schweizer-Arau A, Popovici RM, Meissner K. Psychotherapy With Somatosensory Stimulation for Endometriosis-Associated Pain: The Role of the Anterior Hippocampus. Biol Psychiatry. 2018 Nov 15;84(10):734-742. doi: 10.1016/j.biopsych.2017.01.006. Epub 2017 Jan 16.
Results Reference
derived

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Cortical Plasticity in a Complex Intervention for Endometriosis

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