PainNCT00463177
Augmented Cerebral Pain Processing in Chronic, Unexplained Pain: a fMRI Study
An observational study of Pain, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Chronic, unexplained pain symptoms are very common in all layers of the population, but it is largely unknown what causes them. This study examines the hypothesis that patients with these pain symptoms process pain abnormally in their brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2007to Jun 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic unexplained pain patients
Who may be able to join
- Chronic limb pain > 6 months
- No known somatic cause
Who cannot join
- Chronic benzodiazepine use
- Axis-I psychiatric co-morbidity
- Contra-indications for MRI scanning (e.g. implanted pacemaker)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Augmented Cerebral Pain Processing in Chronic, Unexplained Pain: a 3T Event-Related Functional MRI Study
Chronic, unexplained pain symptoms are very common in all layers of the population, but it is largely unknown what causes them. This study examines the hypothesis that patients with these pain symptoms process pain abnormally in their brain. TO this aim, we compare patients and healthy people: they receive mild pain at their painful body region and at another location. Concurrently, we measure brain activity with brain scans (functional MRI scans). With our study results, we want to increase understanding of what causes chronic, unexplained pain symptoms, in order to find better methods of diagnosing and treating them.
Read the detailed description
Background
Chronic, unexplained pain is a heterogeneously defined, but common and recurring clinical problem, in general medical practice as well as in specialist care. Chronic, unexplained pain causes considerable loss of quality of life, frequent absence from work and it is a common reason for health care visits. From a pathophysiological point of view, an augmented and self-amplifying sensitivity for physical signals such as pain (as well as for other signals) seems to be important. This is referred to as 'generalised hypervigilance', a specific type of sensitisation. Central sensitisation mechanisms have been implied in several pain syndromes. In our own psychophysical pilot study, we confirmed the existence of amplified pain perception in chronic, unexplained pain, as well as the disturbed influence of attentional processes. Our study results probably reflect a general disturbance of perception, not associated with a specific body location. This general perceptual disturbance is expressed in a stronger fashion in the clinically affected body region. Abnormal pattern of cerebral pain processing have been found in functional MRI studies in other syndromes of unknown origin, such as fibromyalgia, somatoform pain disorder and irritable bowel syndrome. However, the role of several neurobiological factors in chronic, unexplained pain remain to be elucidated and to be placed in the context of the biopsychosocial model.
Work plan:
A 3T rapid event-related, Functional MRI-experiment into the cerebral processing of experimental pain stimuli in chronic, unexplained pain-patients versus healthy controls. Twelve chronic, unexplained pain-patients with unilateral limb pain and twelve healthy control subjects experience painful and non-painful electrical stimuli on the painful limb, whilst the attentional state of the subject is controlled. With functional MRI, we record the pain-related cerebral activations and compare them between groups, in order to characterise the cerebral correlates of altered pain processing in chronic, unexplained pain.
- Conditions
- Pain
- Keywords
- Pain, Chronic pain, Pain disorder, Functional MRI, Sensitization
- Medical subject headings
- Pain, Chronic Pain, Somatoform Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- K.F. Hein Foundation, Fonds Psychische Gezondheid
- Investigators
- Tom Snijders, MD, Principal investigator, UMC UtrechtJan van Gijn, MD, Study chair, UMC UtrechtNick Ramsey, PhD, Study director, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463177
- Sponsor's protocol ID
- NFGV5503-02
- Status last verified
- Sep 2008
- First submitted
- 19 Apr 2007
- Last updated
- 4 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Cerebral Pain Processing in Chronic, Unexplained Pain: a 3T Event-Related Functional MRI Study
- ClinicalTrials.gov ID
- NCT00463177
- Acronym / sponsor ID
- NFGV5503-02
- Conditions
- Pain
- Keywords
- Pain, Chronic pain, Pain disorder, Functional MRI, Sensitization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- K.F. Hein Foundation, Fonds Psychische Gezondheid
- Study start
- Mar 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 20 Apr 2007 (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.
Chronic, unexplained pain symptoms are very common in all layers of the population, but it is largely unknown what causes them. This study examines the hypothesis that patients with these pain symptoms process pain abnormally in their brain. TO this aim, we compare patients and healthy people: they receive mild pain at their painful body region and at another location. Concurrently, we measure brain activity with brain scans (functional MRI scans). With our study results, we want to increase understanding of what causes chronic, unexplained pain symptoms, in order to find better methods of diagnosing and treating them.
Detailed description
Background
Chronic, unexplained pain is a heterogeneously defined, but common and recurring clinical problem, in general medical practice as well as in specialist care. Chronic, unexplained pain causes considerable loss of quality of life, frequent absence from work and it is a common reason for health care visits. From a pathophysiological point of view, an augmented and self-amplifying sensitivity for physical signals such as pain (as well as for other signals) seems to be important. This is referred to as 'generalised hypervigilance', a specific type of sensitisation. Central sensitisation mechanisms have been implied in several pain syndromes. In our own psychophysical pilot study, we confirmed the existence of amplified pain perception in chronic, unexplained pain, as well as the disturbed influence of attentional processes. Our study results probably reflect a general disturbance of perception, not associated with a specific body location. This general perceptual disturbance is expressed in a stronger fashion in the clinically affected body region. Abnormal pattern of cerebral pain processing have been found in functional MRI studies in other syndromes of unknown origin, such as fibromyalgia, somatoform pain disorder and irritable bowel syndrome. However, the role of several neurobiological factors in chronic, unexplained pain remain to be elucidated and to be placed in the context of the biopsychosocial model.
Work plan:
A 3T rapid event-related, Functional MRI-experiment into the cerebral processing of experimental pain stimuli in chronic, unexplained pain-patients versus healthy controls. Twelve chronic, unexplained pain-patients with unilateral limb pain and twelve healthy control subjects experience painful and non-painful electrical stimuli on the painful limb, whilst the attentional state of the subject is controlled. With functional MRI, we record the pain-related cerebral activations and compare them between groups, in order to characterise the cerebral correlates of altered pain processing in chronic, unexplained pain.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic unexplained pain patients
Key inclusion criteria (2 listed)
- Chronic limb pain > 6 months
- No known somatic cause
Key exclusion criteria (3 listed)
- Chronic benzodiazepine use
- Axis-I psychiatric co-morbidity
- Contra-indications for MRI scanning (e.g. implanted pacemaker)
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
Not reported in the source record.
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 4 Sep 2008.
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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.
Tom Snijders, MD principal investigator
UMC Utrecht
Jan van Gijn, MD study chair
UMC Utrecht
Nick Ramsey, PhD study director
UMC Utrecht
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 Pain, run by UMC Utrecht at 1 site in Netherlands.
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 2 inclusion and 3 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 4 Sep 2008. 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 Netherlands. 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.
Where can I read the original study information?
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 4 Sep 2008.