- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00463177
Augmented Cerebral Pain Processing in Chronic, Unexplained Pain: a fMRI Study
Augmented Cerebral Pain Processing in Chronic, Unexplained Pain: a 3T Event-Related Functional MRI Study
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Utrecht, Netherlands, 3584 CX
- UMC Utrecht
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Chronic limb pain > 6 months
- No known somatic cause
Exclusion Criteria:
- Chronic benzodiazepine use
- Axis-I psychiatric co-morbidity
- Contra-indications for MRI scanning (e.g. implanted pacemaker)
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tom Snijders, MD, UMC Utrecht
- Study Chair: Jan van Gijn, MD, UMC Utrecht
- Study Director: Nick Ramsey, PhD, UMC Utrecht
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NFGV5503-02
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