Prognostic Factors for Complex Regional Pain Syndrome

Complex Regional Pain Syndromes Clinical Trial

Official title:

Prognostic Factors for Complex Regional Pain Syndrome: a Longitudinal Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05337501
• Other study ID #: CRPSPrognosis
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: March 28, 2024

Study information

• Verified date: October 2022
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Anne Berquin, PhD
• Phone: +32 2 764 70 09
• Email: anne.berquin[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 28, 2024
• Est. primary completion date: March 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

Other:
• Collecting data
Anamnesis, clinical examination, Quantitative Sensory Testing (following DFNS, German Research Network on Neuropathic Pain, protocol), visual TOJ (Temporal Order Judgement) task

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Woluwe-Saint-Lambert	Bruxelles-Capitale

Sponsors (3)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Fondation Saint Luc, Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

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. — View Citation

Bruehl S, Maihöfner 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Return to work	Rate of patients returning to work at 1 year (full time and / or medical part-time)	12 months
Secondary	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
Secondary	Body function - CRPS severity score	Defined by Harden et al., signs + symptoms, 0 to 16 scale ; higher score means higher severity	12 months