Study of Proteins Associated With Complex Regional Pain Syndrome (NCT00033969) | Clinical Trial Compass
TerminatedNot Applicable
Study of Proteins Associated With Complex Regional Pain Syndrome
United States120 participantsStarted 2002-04-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA
* Male or female patients referred by their physician with the diagnosis of CRPS criteria as outlined by Stanton-Hicks et al.
OR
* Healthy volunteers will be screened according to the eligibility criteria as specified in the appendix (see Healthy Subject Eligibility).
* Age restrictions: Patients and volunteers must be (Bullet)18 years of age at the time of enrollment. There is no upper limit for age of inclusion.
* Good general health (other disease states could may confound the results see exclusion criteria)
* 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
* Contraindication 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.
* Pregnant and lactating women.
No exclusions will be made based on race, gender, or religion.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00033969
SponsorNational Institute of Nursing Research (NINR)