Study of Proteins Associated With Complex Regional Pain Syndrome

NCT00033969 | Terminated

• 2 other identifiers: 02016902-NR-0169
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Regional Pain Syndromes; Healthy

Keywords

CRPS; RSD; Causalgia; Chronic Pain; Neuropathic Pain; Normal Control; Complex Regional Pain Syndrome; Healthy Volunteer; HV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients referred by their physician with the diagnosis of CRPS criteria as outlined by Stanton-Hicks et al.
• Healthy volunteers will be screened according to the eligibility criteria as specified in the appendix (see Healthy Subject Eligibility).

You may not qualify if:

• 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.
• Contraindication to blood screening
• Pregnant and lactating women.

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Bichsel VE, Liotta LA, Petricoin EF 3rd. Cancer proteomics: from biomarker discovery to signal pathway profiling. Cancer J. 2001 Jan-Feb;7(1):69-78.

  PMID: 11269650 BACKGROUND

• Bittner M, Meltzer P, Chen Y, Jiang Y, Seftor E, Hendrix M, Radmacher M, Simon R, Yakhini Z, Ben-Dor A, Sampas N, Dougherty E, Wang E, Marincola F, Gooden C, Lueders J, Glatfelter A, Pollock P, Carpten J, Gillanders E, Leja D, Dietrich K, Beaudry C, Berens M, Alberts D, Sondak V. Molecular classification of cutaneous malignant melanoma by gene expression profiling. Nature. 2000 Aug 3;406(6795):536-40. doi: 10.1038/35020115.

  PMID: 10952317 BACKGROUND

• Chelimsky TC, Low PA, Naessens JM, Wilson PR, Amadio PC, O'Brien PC. Value of autonomic testing in reflex sympathetic dystrophy. Mayo Clin Proc. 1995 Nov;70(11):1029-40. doi: 10.4065/70.11.1029.

  PMID: 7475332 BACKGROUND

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Causalgia; Chronic Pain; Neuralgia

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew J Mannes, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 17, 2002
• First Posted: April 18, 2002
• Study Start: April 15, 2002
• Study Completion: October 23, 2014
• Last Updated: December 12, 2019

Record last verified: 2014-10-23

Locations

US (1)