Assessment of a Specific Neurophysiological Brain Pattern in Patients Suffering From Chronic Back Pain

This study has been completed.
Sponsor:
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00744575
First received: August 29, 2008
Last updated: October 8, 2010
Last verified: January 2009
  Purpose

The purpose of this study is whether patients suffering from chronic back pain for more than one year will show a specific neurophysiological pattern in the EEG. This pattern is referred to as Thalamo-Cortical Dysrhythmia (TCD) and consists most likely of a self sustaining loop between the Cortex and Thalamus. This pattern has been found before in patients with very severe chronic pain. Specific lesions to the Thalamus result in a reduction of this pattern and decrease in pain. With this study the investigators will assess whether this pattern can be found in back pain patients of different types. Patients will be measured by EEG for the existence of TCD and will undergo detailed pain and psychological diagnostic.


Condition
Back Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of a Specific Neurophysiological Brain Pattern in Patients Suffering From Chronic Back Pain

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Difference in EEG signature and pain perception between groups [ Time Frame: 25 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life, pain perception, neuropathic pain questionnaire, brief symptom inventory, life satisfaction [ Time Frame: 25 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Chronic Back Pain
2
Healthy Sex & Age Matched Controls

Detailed Description:

The neurophysiological processing of chronic pain is despite large efforts in the recent years still not well understood. However the so called cortical pain matrix describes cortical areas associated with the perception and processing of pain stimuli. Most studies identify second somatic area (SII), the insular regions, the anterior cingulated cortex (ACC) as well as the contralateral thalamus and the primary somatic area (SI) (Peyron, Laurent & Garcia-Larrea, 2000) as areas related to pain processing. In two recent publications by a Swiss research group (Sarnthein, Stern, Aufenberg, Rousson & Jeanmonod, 2006; Stern, Jeanmonod & Sarnthein, 2006) a dynamical EEG in the cortex pattern is described which is obvious related to chronic neurogenic pain. This pattern consists of an increase in EEG power and a shift of the dominant peak towards lower frequencies, mainly high theta (6-9 Hz). Source localization demonstrates that this overactivation mainly takes place in the areas of the cortical pain matrix. The authors argue that this pattern termed thalamocortical dysrhythmia is due to a thalamocortical loops initiated from the central lateral nucleus in the thalamus. This hypothesis is supported by the effects of a therapeutic lesion within the thalamus which led to (a) pain relief of 95% and to (b) the disappearance of the dysrhythmic pattern described above.

The investigators will set out to conduct a observational trial in order to determine pain related EEG characteristics in patients suffering from chonic back pain. Twenty four patients will be recruited for the study. A 64 channel high-resolution EEG and the following parameter will be recorded: Neuropathic Pain Questionnaire (Backonja and Krause 2003), EuroQol, BSI, Graded hronic pain scale(Klasen, Hallner, Schaub, Willburger & Hasenbring, 2004)pain (McGill Pain Questionnaire, VAS pain), and generic quality of life (Fragebogen zur Lebenszufriedenheit, Henrich & Herschbach, 1996).

An age and sex matched control group of healthy participants will be measured with the same method in order to compare whether the patients show a dysrhythmia pattern.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

chronic back pain

Criteria

Inclusion Criteria:

  • Chronic back pain of at least one year duration
  • Command of German language
  • Age 18-70

Exclusion Criteria:

  • Psychiatric disorders
  • Immune suppression
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744575

Locations
Germany
University Medical Center Freiburg
Freiburg, Germany, 79106
Sponsors and Collaborators
University Hospital Freiburg
Investigators
Principal Investigator: Stefan M Schmidt, PhD Universtiy Medical Center Freiburg
  More Information

No publications provided by University Hospital Freiburg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PhD Stefan Schmidt, University Hospital Freibung
ClinicalTrials.gov Identifier: NCT00744575     History of Changes
Other Study ID Numbers: 200/08
Study First Received: August 29, 2008
Last Updated: October 8, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Freiburg:
back pain
eeg
chronic pain

Additional relevant MeSH terms:
Back Pain
Stress, Psychological
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 23, 2014