An interventional study of Collecting data in Complex Regional Pain Syndromes, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Active, not recruiting at 1 site in Belgium. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Prevention
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The investigators would like to examine the role of some relevant biopsychosocial factors in the development of persistent CRPS. According to the International Classification of Functioning, Disability and Health (ICF) [43], the outcomes will belong to one of the three following components:
The secondary aims are:
Patients suffering from early CRPS will be invited to attend 4 medical interviews over a 1-year period. A series of clinical data will be collected during this interview. After each consultation, the patient will be asked to complete a series of questionnaires at home (paper forms or online by REDCap). These questionnaires assess various psychosocial factors well known in the chronification of pain (fear of movement, anxious or depressive traits, "general" pain sensitization, social support, cognitive strategies to cope with pain) as well as the functional impact of the pathology.
All the study (first face-to-face assessment or follow-up sessions) will take place at Institute of Neurosciences (UCLouvain, site Woluwé) and perform by Pr. Berquin or Dr. Louis. As part of the study, the patients will never be assessed in another location or by another investigator.
After having encoded the patients' details in the REDCap application, the participants will receive an automatic e-mail at every time point. It will include a link to the online survey. At any given moment of the study, they can contact the co-investigator (Dr. Louis) by e-mail or phone for any questions or help in completing the questionnaires. If necessary, the co-investigator will provide assistance by telephone
To simplify the recruitment process, the informed consent will be sent by post or e-mail and signed during the first meeting.
Five endpoints will be tested using linear mixed-effects regression models for repeated measures:
Primary endpoint: disability Secondary endpoints: participation-QoL, return to work, pain, CRPS severity score.
A latent profiles analysis will be performed to classify patients into subgroups based on variables at baseline and the risk of chronicity of profile will be computed.
206 studies on the registry are indexed under Complex Regional Pain Syndromes; 54 are open to participants now.
This study's enrollment of 113 is above the median of 40 across 152 interventional studies indexed under Complex Regional Pain Syndromes.
Browse Complex Regional Pain Syndromes studies →Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 350 studies on the registry; 64 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Collecting data
Anamnesis, clinical examination, Quantitative Sensory Testing (following DFNS, German Research Network on Neuropathic Pain, protocol), visual TOJ (Temporal Order Judgement) task
Disability
Defined by International Classification of Functioning, Disability and Health (ICF), assessed by Quick DASH (0 to 100 scale) or Lower Extremity Functional Scale (LEFS) (0 to 80 scale) ; higher score means higher disability
Time frame: 12 months
Participation - QoL
Defined by International Classification of Functioning, Disability and Health (ICF), assessed by EuroQol5D5L ; higher score in each domain means lower QoL ; lower score in visual analogic scale means lower QoL
Time frame: 12 months
Return to work
Rate of patients returning to work at 1 year (full time and / or medical part-time)
Time frame: 12 months
Body function - Pain intensity
Defined by International Classification of Functioning, Disability and Health (ICF), assessed by SF-BPI ; pain intensity (severity, means of 4 first items) and the impact of pain on functioning (interference, mean of the seven interference items on a 0-10 scale) ; higher scores mean higher pain (severity or interference)
Time frame: 12 months
Body function - CRPS severity score
Defined by Harden et al., signs + symptoms, 0 to 16 scale ; higher score means higher severity
Time frame: 12 months
Plan to share: No
Started Mar 2022 (actual). Primary completion is estimated for Dec 2024, 33 months after the start.
Of 64 non-industry interventional studies with no phase under Complex Regional Pain Syndromes, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 33 months is above that.
Counting every sponsor, half of 65 studies reached it within 24 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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