Back PainNCT00744575
Assessment of a Specific Neurophysiological Brain Pattern in Patients Suffering From Chronic Back Pain
An observational study of Back Pain, run by University Hospital Freiburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2008to Jun 2009
- Phase
- Observational
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: chronic back pain
Who may be able to join
- Chronic back pain of at least one year duration
- Command of German language
- Age 18-70
Who cannot join
- Psychiatric disorders
- Immune suppression
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Back Pain
- Keywords
- back pain, eeg, chronic pain
- Medical subject headings
- Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Chronic Back Pain | |
| 2 | Healthy Sex \& Age Matched Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in EEG signature and pain perception between groups
Measured: 25 months
Secondary outcomes (1)
Quality of life, pain perception, neuropathic pain questionnaire, brief symptom inventory, life satisfaction
Measured: 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Investigators
- Stefan M Schmidt, PhD, Principal investigator, Universtiy Medical Center Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744575
- Sponsor's protocol ID
- 200/08
- Status last verified
- Jan 2009
- First submitted
- 29 Aug 2008
- Last updated
- 11 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26565981Schmidt 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.
PubMed 22431961
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Specific Neurophysiological Brain Pattern in Patients Suffering From Chronic Back Pain
- ClinicalTrials.gov ID
- NCT00744575
- Acronym / sponsor ID
- 200/08
- Conditions
- Back Pain
- Keywords
- back pain, eeg, chronic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 1 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Chronic Back Pain |
| 2 | – | –Healthy Sex \& Age Matched Controls |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- chronic back pain
Key inclusion criteria (3 listed)
- Chronic back pain of at least one year duration
- Command of German language
- Age 18-70
Key exclusion criteria (2 listed)
- Psychiatric disorders
- Immune suppression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in EEG signature and pain perception between groups
Time frame: 25 months
1 secondary outcome
Quality of life, pain perception, neuropathic pain questionnaire, brief symptom inventory, life satisfaction
Time frame: 25 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2010.
- Derived from this study: PubMed 26565981Schmidt 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.
- Derived from this study: PubMed 22431961Schmidt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan M Schmidt, PhD principal investigator
Universtiy Medical Center Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Back Pain, run by University Hospital Freiburg at 1 site 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 3 inclusion and 2 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 11 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Difference in EEG signature and pain perception between groups (time frame: 25 months). 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 NCT00744575, 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 11 Oct 2010.