Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033969
Status:
TERMINATED
Last Update Posted:
2019-12-12
First Post:
2002-04-17
Brief Title:
Study of Proteins Associated With Complex Regional Pain Syndrome
Sponsor:
National Institute of Nursing Research NINR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Complex Regional Pain Syndrome Proteomics Study
Status:
TERMINATED
Status Verified Date:
2014-10-23
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 for protein and gene expression RNA analysis 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
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 for protein and gene expression RNA analysis 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-NR-0169 | None | None | None |