Cortical Plasticity in a Complex Intervention for Endometriosis

University of Jena

Status: Completed

Conditions: Endometriosis

Treatments: Procedure: Specific Autoregulation Therapy (SART)

Study type: Interventional

Funder types: Other

Identifiers

NCT01321840

Jena-Endo-01

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Treatment

Experimental group

Description:

This group will be treated with SART.

Treatment:

Procedure: Specific Autoregulation Therapy (SART)

No treatment

No Intervention group

Description:

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