Longitudinal Follow-up Study About Complex Regional Pain Syndrome (CRPS). Which Are the Predictors for Return to Work and Recovery
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY
Complex regional pain syndrome (CRPS) is a post-traumatic chronic pain condition characterized by pain and other symptoms typically affecting a distal limb. Relatively little is known about the prognosis of the course of CRPS .Currently there is no specific test to diagnose CRPS. The primary objective of the study is to investigate prospectively the evolution of CRPS and the impact of the psychosocial factors on health status, recovery, quality of life, and working status of CRPS patients. The secondary objective of the study is to measure blood parameters in CRPS patients to investigate their evolution during the course of CRPS, and maybe to identify distinctive biomarkers associate with CRPS and that could be potential candidate for diagnosis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• CRPS Type I (fulfilling Budapest criteria for research)
• Suffering of CRPS in a distal limb (hand or foot)
• Age \>18 years
• Pain lasting less than 6 months
• Good understanding of the French language
• Not suffering from chronic pain, including CRPS
• Age \>18 years
Locations
Other Locations
Switzerland
Clinique romande de réadaptation
RECRUITING
Sion
Contact Information
Primary
michel Konzelmann, MD
michel.konzelmann@crr-suva.ch
+41 79 314 84 84
Time Frame
Start Date:2019-03-14
Estimated Completion Date:2025-12-31
Participants
Target number of participants:110
Treatments
Patients with CRPS type 1: prospective group
Ambulatory patients of the Clinique romande de réadaptation (CRR) which have a CRPS type 1 of a limb.~Five measurement times (first visit (T0) and then after 3 (T1), 6 (T2), 12 (T3) and 24 (T4) months). At every time point, following data will be collected: physical examination, monitoring of the health and professional status with the physician, and self-administrated questionnaires. Blood sampling will be performed at T0, T1,T2 and T3.~Eight different self-administrated questionnaires will be used, in their French or Portuguese version. Each participants will answer seven questionnaires each time, depending if he/she suffers of arm or leg injury.~We will assess, in blood samples, the expression levels of specific molecules (miRNAs and a selection of cytokines) in patients diagnosed with acute CRPS. In a second time, miRNAs and cytokines profiles will be compared between acute and chronic (CRPS still diagnosed 6 months after the first diagnosis) CRPS patients.
control group for blood analysis
For the blood analysis, we will recruit 30 healthy controls who did not report any kind of pain. They will be recruited via posters that will be posted on the billboards of the Hôpital de Sion (employees and visitors) and on the visitor's billboards of the CRR. If this is not enough, we will expand the recruitment perimeter with other locations. The healthy control will be adjusted for age, sex and BMI with the CRPS groups. They will be informed about the study and procedure. The procedure for the blood samples will be the same as for patients.The screening for miRNAs of interest will be performed using a decision tree-based ensemble method (Random Forest). For this step, miRNAs profile of 30 control patients will be compared to the same number of CRPS patients.~The control group will have just one blood analysis.