NCT00744575

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

October 11, 2010

Status Verified

January 1, 2009

Enrollment Period

10 months

First QC Date

August 29, 2008

Last Update Submit

October 8, 2010

Conditions

Keywords

back paineegchronic pain

Outcome Measures

Primary Outcomes (1)

  • Difference in EEG signature and pain perception between groups

    25 months

Secondary Outcomes (1)

  • Quality of life, pain perception, neuropathic pain questionnaire, brief symptom inventory, life satisfaction

    25 months

Study Arms (2)

1

Chronic Back Pain

2

Healthy Sex \& Age Matched Controls

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

chronic back pain

You may qualify if:

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

You may not qualify if:

  • Psychiatric disorders
  • Immune suppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Related Publications (2)

  • Schmidt S, Gmeiner S, Schultz C, Lower M, Kuhn K, Naranjo JR, Brenneisen C, Hinterberger T. Mindfulness-based Stress Reduction (MBSR) as Treatment for Chronic Back Pain - an Observational Study with Assessment of Thalamocortical Dysrhythmia. Forsch Komplementmed. 2015;22(5):298-303. doi: 10.1159/000440687. Epub 2015 Oct 16.

  • Schmidt S, Naranjo JR, Brenneisen C, Gundlach J, Schultz C, Kaube H, Hinterberger T, Jeanmonod D. Pain ratings, psychological functioning and quantitative EEG in a controlled study of chronic back pain patients. PLoS One. 2012;7(3):e31138. doi: 10.1371/journal.pone.0031138. Epub 2012 Mar 14.

MeSH Terms

Conditions

Back PainChronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan M Schmidt, PhD

    Universtiy Medical Center Freiburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2008

First Posted

September 1, 2008

Study Start

August 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

October 11, 2010

Record last verified: 2009-01

Locations