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Study of Proteins Associated With Complex Regional Pain Syndrome
This study has been completed.
Study NCT00033969   Information provided by National Institutes of Health Clinical Center (CC)
First Received: April 17, 2002   Last Updated: August 24, 2009   History of Changes

April 17, 2002
August 24, 2009
April 2002
December 2007   (final data collection date for primary outcome measure)
 
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Complete list of historical versions of study NCT00033969 on ClinicalTrials.gov Archive Site
 
To determine the response rate to PHP in patients with cutaneous and ocular melanoma metastatic to liver.
 
Study of Proteins Associated With Complex Regional Pain Syndrome
Complex Regional Pain Syndrome Proteomics Study

This study will try to learn more about complex regional pain syndrome, or CRPS (previously known as reflex sympathetic dystrophy, spreading neuralgia, and sympathalgia), by examining the release of small proteins in the blood of patients with this condition. Patients with CRPS usually have three types of symptoms:

  • Sensory abnormalities - increased sensitivity to pain or a painful reaction to a harmless stimulus
  • Perfusion abnormalities - alterations in blood flow, temperature abnormality, swelling, decrease or increased nail growth, and hair and skin changes
  • Motor abnormalities - weakness, guarding (Holding the limb in such a fashion that it minimizes accidental or intentional contact from possible sources of pain), and atrophy (wasting)

The cause of CRPS is unknown, and there are no definitive diagnostic tests for the condition. Because early treatment improves the prognosis of CRPS, a test that enables early diagnosis would be important for optimal medical management. The findings of this study may contribute to the development of such a test and possibly new drug treatments.

Normal healthy volunteers and patients of any age with complex regional pain syndrome who are in otherwise good general health may be eligible for this study.

Participants will have a medical history, physical examination and collection of a blood sample. They will fill out several questionnaires, providing information on their health, personality, mood, pain levels, and symptoms. Participation in the study requires one outpatient clinic visit.

...

The etiology of Complex Regional Pain Syndrome (CRPS) is unknown but a patient typically presents with a triad of clinical findings: sensory abnormalities, perfusion abnormalities and alterations in motor function. Since some of these findings are seen in the other disease states, the diagnosis is often not clear. A response to a sympathetic ganglion block (stellate or lumbar) is also suggestive of the disorder. However, there is no definitive diagnostic test for CRPS. Experience has shown that early aggressive treatment improves the prognosis. Therefore, tests that facilitate the early diagnosis would have important clinical implications.

Advances in laboratory techniques allow analysis of clinical samples to identify protein or patterns of protein changes associated with a disease state. Patients suffering with CRPS who are currently seen in a pain clinic will be asked to participate in this study. The subjects will complete a brief symptom survey, be examined by a co-investigator to document sensory, temperature and trophic changes, and have a blood sample collected. Blood samples from age-matched controls will be collected from non-CRPS patients. Fifty patient samples collected from each group will be analyzed and used to teach the diagnostic software and an additional 20 samples (10 controls, 10 CRPS patients) will be used to validate diagnostic accuracy.

 
Observational
 
  • Complex Regional Pain Syndromes
  • Healthy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
120
 
December 2007   (final data collection date for primary outcome measure)
  • INCLUSION CRITERIA

Male or female volunteers referred by their physician with the diagnosis of CRPS

Age restrictions: none

Good general health

Willing to have blood drawn

Willing to have behavioral measures

Willing to provide a directed medical history

There is expected to be a greater number of females than males being recruited to this study since there is a much higher occurrence of CRPS in women. Additionally, it is expected to be equal across all ethnic groups. However, we do not anticipate requiring any special recruiting strategies for specific gender or ethnic groups.

EXCLUSION CRITERIA

Contradiction to blood screening

Advanced disease other than the CRPS (cardiovascular, liver, kidney disease-ASA III or above excluding CRPS) that may cause a theoretical inclusion of samples resulting in confounding results.

No exclusions will be made based on race, gender, or religion.

Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00033969
 
020169, 02-D-0169
National Institute of Dental and Craniofacial Research (NIDCR)
 
 
National Institutes of Health Clinical Center (CC)
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP