Augmented Cerebral Pain Processing in Chronic, Unexplained Pain: a fMRI Study

This study has been completed.
Sponsor:
Collaborators:
K.F. Hein Stichting
Fonds Psychische Gezondheid
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00463177
First received: April 19, 2007
Last updated: September 3, 2008
Last verified: September 2008
  Purpose

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.


Condition
Pain

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Augmented Cerebral Pain Processing in Chronic, Unexplained Pain: a 3T Event-Related Functional MRI Study

Further study details as provided by UMC Utrecht:

Enrollment: 24
Study Start Date: March 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Chronic unexplained pain patients

Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00463177

Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
K.F. Hein Stichting
Fonds Psychische Gezondheid
Investigators
Principal Investigator: Tom Snijders, MD UMC Utrecht
Study Chair: Jan van Gijn, MD UMC Utrecht
Study Director: Nick Ramsey, PhD UMC Utrecht
  More Information

No publications provided

Responsible Party: UMC Utrecht, -
ClinicalTrials.gov Identifier: NCT00463177     History of Changes
Other Study ID Numbers: NFGV5503-02
Study First Received: April 19, 2007
Last Updated: September 3, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Pain
Chronic pain
Pain disorder
Functional MRI
Sensitization

ClinicalTrials.gov processed this record on August 26, 2014