Prognostic Factors for Complex Regional Pain Syndrome

Not Applicable

Active, not recruiting

• Conditions: Complex Regional Pain Syndromes
• Interventions: Other: Collecting data

• Registration Number: NCT05337501
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

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:

* Body structures and functions (pain, CRPS severity score (CSS)),

* Activities (disability)

* Participation (return to work, quality of life). The primary aim is to assess predicting factors for chronification.

The secondary aims are:

* to evaluate if it is possible to classify acute complex regional pain syndrome (CRPS) patients into subgroups according to their risk of chronification.

* to document the course of the disease. The main evaluation criteria will be to determine the impact of the different clinical and non-clinical variables on the course of the CRPS and on the aforementioned outcomes then, which will use as endpoints.

* Primary endpoint: disability

* Secondary endpoints: participation-QoL, return to work, pain, CRPS severity score.

Detailed Description

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.

Study Timeline

• Study Start: 2022-03-28
• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-05-01
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

1. Aged over 18,
2. Meeting the clinical Budapest criteria,
3. Apparition of symptoms from less than 6 months,
4. CRPS type I or II,
5. Capacity to understand and voluntarily sign an informed consent form in French.

Exclusion Criteria

1. Insufficient French language skills to answer questionnaires,
2. Personal history of CRPS at the same limb,
3. Post-stroke CRPS type I ("shoulder-hand syndrome"),
4. Psychiatric disorders that would interfere with the participants' ability to complete study tasks,
5. The following hormonal situations: gravidity, lactation, gender-affirming treatment,
6. Any other reason to exclude the subject because it may interfere with the study, according to judgment by the investigator. The reason will be documented.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients group	Collecting data	-

Primary Outcome Measures

Name	Time	Method
Disability	12 months	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

Secondary Outcome Measures

Name	Time	Method
Return to work	12 months	Rate of patients returning to work at 1 year (full time and / or medical part-time)
Body function - Pain intensity	12 months	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)
Body function - CRPS severity score	12 months	Defined by Harden et al., signs + symptoms, 0 to 16 scale ; higher score means higher severity
Participation - QoL	12 months	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

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium