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| Name | Class |
|---|---|
| Université Catholique de Louvain | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collecting data | Other | Anamnesis, clinical examination, Quantitative Sensory Testing (following DFNS, German Research Network on Neuropathic Pain, protocol), visual TOJ (Temporal Order Judgement) task |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Return to work |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Berquin, PhD | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint-Luc | Woluwe-Saint-Lambert | Brussels Capital | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28715350 | Background | Harden RN, Maihofner C, Abousaad E, Vatine JJ, Kirsling A, Perez RSGM, Kuroda M, Brunner F, Stanton-Hicks M, Marinus J, van Hilten JJ, Mackey S, Birklein F, Schlereth T, Mailis-Gagnon A, Graciosa J, Connoly SB, Dayanim D, Massey M, Frank H, Livshitz A, Bruehl S. A prospective, multisite, international validation of the Complex Regional Pain Syndrome Severity Score. Pain. 2017 Aug;158(8):1430-1436. doi: 10.1097/j.pain.0000000000000927. | |
| 26524108 |
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| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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Prospective longitudinal observational study
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Rate of patients returning to work at 1 year (full time and / or medical part-time) |
| 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) | 12 months |
| Body function - CRPS severity score | Defined by Harden et al., signs + symptoms, 0 to 16 scale ; higher score means higher severity | 12 months |
| Background |
| Bean DJ, Johnson MH, Heiss-Dunlop W, Kydd RR. Extent of recovery in the first 12 months of complex regional pain syndrome type-1: A prospective study. Eur J Pain. 2016 Jul;20(6):884-94. doi: 10.1002/ejp.813. Epub 2015 Nov 2. |
| 28573699 | Background | Brunner F, Bachmann LM, Perez RSGM, Marinus J, Wertli MM. Painful swelling after a noxious event and the development of complex regional pain syndrome 1: A one-year prospective study. Eur J Pain. 2017 Oct;21(9):1611-1617. doi: 10.1002/ejp.1064. Epub 2017 Jun 2. |
| 18573212 | Background | Brunner F, Bachmann LM, Weber U, Kessels AG, Perez RS, Marinus J, Kissling R. Complex regional pain syndrome 1--the Swiss cohort study. BMC Musculoskelet Disord. 2008 Jun 23;9:92. doi: 10.1186/1471-2474-9-92. |
| 27023422 | Background | Bruehl S, Maihofner C, Stanton-Hicks M, Perez RS, Vatine JJ, Brunner F, Birklein F, Schlereth T, Mackey S, Mailis-Gagnon A, Livshitz A, Harden RN. Complex regional pain syndrome: evidence for warm and cold subtypes in a large prospective clinical sample. Pain. 2016 Aug;157(8):1674-81. doi: 10.1097/j.pain.0000000000000569. |
| 41065599 | Derived | Louis MH, Legrain V, Aron V, Filbrich L, Mouraux A, Henrard S, Guillaume L, Mouraux D, Barbier O, Libouton X, Berquin A. Complex regional pain syndrome evolution is determined by both biological and psychosocial factors: a 1-year prospective observational study. Pain. 2026 Feb 1;167(2):396-413. doi: 10.1097/j.pain.0000000000003815. Epub 2025 Oct 8. |