The first aim will be to monitor the evolution of the following parameters in CRPS
patients:
Additionally sociodemographic data will be collected to characterize the patients (age,
gender, marital status, educational level). The health status, treatment and medication
of the patients will also be recorded with a medical follow-up during the two years.
The aim is to know if the following parameters and their evolution:
are associated with the recovery, which is evaluated with
Quality of life,
Severity of CRPS,
And working status.
Potential associations between the different parameters will be tested (Pearson's
correlation coefficient).
The second aim will be to assess, in blood samples, the expression levels of specific
molecules (miRNAs and a selection of cytokines) in patients diagnosed with acute CRPS.
Comparison with healthy controls will be performed at the first measurement time (T0) .
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. The
measured proteins will include: C-reactive protein, tumor necrosis factor-alpha (TNF),
interleukin-2 [IL-2], IL-6, IL-8, IL-10, CD40 ligand (pro- and anti-inflammatory proteins
associated with pain), gene related peptide (CGRP), bradykinins and substance P.
The screening, recruitment and enrolment of the patients will be done by the referring
physician in daily clinical practice, during the consultation.
The physician will explain to each participant the nature of the study, its purpose, the
procedures involved, the expected duration, the potential risks and benefits and any
discomfort it may entail. Each participant will be informed that the participation in the
study is voluntary and that he/she may withdraw from the study at any time and that
withdrawal of consent will not affect his/her subsequent medical assistance and
treatment.
All participants for the study will be provided with a participant information sheet,a
consent form describing the study and providing sufficient information for participant to
make an informed decision about their participation in the study and a prepaid envelope.
Each patient may decide separately to participate in a) longitudinal follow-up
questionnaires, b) blood tests or c) both parts of the study (questionnaire and blood
samples). The delay for reflection will be 24 h. Once this period has expired, if the
patient agrees to participate in the study, he or she is asked to return the consent form
in the prepaid envelope. If he or she has not been send back after one week, the
physician will call the patient by phone to make sure that it is not an omission.
The patient information sheet and the consent form are submitted to the Ethic comitee to
be reviewed and approved. The formal consent of a participant, using the approved consent
form, must be obtained before the participant is submitted to any study procedure.
The participant should read and consider the statement before signing and dating the
informed consent form, and should be given a copy of the signed document. If the patient
sent back the informed consent, a next appointment will be scheduled at the CRR where he
or she will be asked to submit the signed consent form. The consent form must also be
signed and dated by the investigator (or his designee) and it will be retained as part of
the study records.
The total duration of the project is planned over a six years period (2019-2024). The
study will be proposed to every CRPS ambulatory patient in the CRR (2019-2022), inclusion
period). The study will also be proposed to the patients during the last two years
(2023-2024) but only partially, since that last questionnaires will be sent in December
2024.
The CRPS patients are monitored on a regular and long-term basis at the CRR. The
physician see them very regularly at the beginning (about once a month) and then the
visits space a little out. Thus, our study fits into routine procedure and should not
imply additional visits.
At the first visit at the clinic, the physician will proposed the study to the patient.
Upon acceptance, the patient will be included into the study. It consists in five
measurement times:
T0: During the days following the first visit to the clinic
T1: Follow up visit 3 months later
T2: Follow up visit 6 months later
T3: Follow up visit 12 months later
T4: Follow up visit 24 months later