Cortical Plasticity in a Complex Intervention for Endometriosis

Endometriosis Clinical Trial

Official title:

Investigation of Cortical Plasticity in a Complex Intervention for Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321840
• Other study ID #: Jena-Endo-01
• Status: Completed
• Phase: N/A
• First received: March 23, 2011
• Last updated: January 5, 2017
• Start date: March 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2017
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Endometriosis

Intervention

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.

Locations

Country	Name	City	State
Germany	Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie	Jena
Germany	Frauenklinik der Technischen Universität München	München

Sponsors (2)

Lead Sponsor	Collaborator
University of Jena	Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain function	Changes in cortical thickness, functional connectivity and perfusion of brain areas related to the processing of pain and emotions.	12 weeks	No
Secondary	Reduction of pain	Reduction of pain by 50% or more (dichotomous).	12 weeks	No
Secondary	Pain scores	Changes (ordinal) in pain scores as assessed by the questionnaire of the German Society For The Study Of Pain (DGSS).	12 wks	No
Secondary	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).	12 wks	No
Secondary	Endometriosis-related symptoms	Normalization of menstruation, pelvic pain, dyspareunia, defecation pain as assessed by the Erlangen Endometriosis questionnaire.	12 wks	No
Secondary	HRV (HF, LF, LF/HF)	heart rate variability parameters	12 wks	No