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EndometriosisNCT01321840

Cortical Plasticity in a Complex Intervention for Endometriosis

A study testing Specific Autoregulation Therapy (SART) in people with Endometriosis, run by University of Jena at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometriosis
What is being tested?
Specific Autoregulation Therapy (SART)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesGermany
Study dates
Mar 2010to Dec 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

Germany2 sites

  • Pain & Autonomics - Integrative Research, Klinik für Psychiatrie und Psychotherapie

    Jena, 07743

  • Frauenklinik der Technischen Universität München

    München, 81675

Other trials in Germany

About this study

Official title: Investigation of Cortical Plasticity in a Complex Intervention for Endometriosis

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.

Conditions
Endometriosis
Being tested
Specific Autoregulation Therapy (SART)
Keywords
Endometriosis, pain, sart, autonomic nervous system, fMRI, perfusion, connectivity, hypnotherapy, traditional Chinese medicine
Medical subject headings
Endometriosis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Specific Autoregulation Therapy (SART)Procedure or surgery

    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 groups in NCT01321840
Study groupRoleWhat they receive
TreatmentExperimentalThis group will be treated with SART.
Receives: Procedure: Specific Autoregulation Therapy (SART)
No treatmentNo interventionThis group will not be treated with SART but will regularly be examined by a gynecologist to detect sudden aggravation of the disease.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Brain function

    Changes in cortical thickness, functional connectivity and perfusion of brain areas related to the processing of pain and emotions.

    Measured: 12 weeks

Secondary outcomes (5)

  1. Reduction of pain

    Reduction of pain by 50% or more (dichotomous).

    Measured: 12 weeks

  2. Pain scores

    Changes (ordinal) in pain scores as assessed by the questionnaire of the German Society For The Study Of Pain (DGSS).

    Measured: 12 wks

  3. 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).

    Measured: 12 wks

  4. Endometriosis-related symptoms

    Normalization of menstruation, pelvic pain, dyspareunia, defecation pain as assessed by the Erlangen Endometriosis questionnaire.

    Measured: 12 wks

  5. HRV (HF, LF, LF/HF)

    heart rate variability parameters

    Measured: 12 wks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2011 (estimated)
  2. Study startMar 2010
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01321840
Sponsor's protocol ID
Jena-Endo-01
Status last verified
Jan 2017
First submitted
23 Mar 2011
Last updated
6 Jan 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27741200

  • 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.

    PubMed 28258747

Questions about this trial

What is this clinical trial studying?

A study testing Specific Autoregulation Therapy (SART) in people with Endometriosis, run by University of Jena at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain function (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01321840, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.

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