Cortical Plasticity in a Complex Intervention for Endometriosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment

This group will be treated with SART.

Group Type EXPERIMENTAL

Specific Autoregulation Therapy (SART)

Intervention Type PROCEDURE

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 treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No