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Prognostic Factors for Complex Regional Pain Syndrome

Primary Purpose

Complex Regional Pain Syndromes

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Collecting data
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Complex Regional Pain Syndromes

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cliniques Universitaires Saint-LucRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 6, 2022
Last Updated
October 10, 2022
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators
Fondation Saint Luc, Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT05337501
Brief Title
Prognostic Factors for Complex Regional Pain Syndrome
Official Title
Prognostic Factors for Complex Regional Pain Syndrome: a Longitudinal Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
March 28, 2024 (Anticipated)
Study Completion Date
March 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators
Fondation Saint Luc, Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndromes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective longitudinal observational study
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Collecting data
Intervention Description
Anamnesis, clinical examination, Quantitative Sensory Testing (following DFNS, German Research Network on Neuropathic Pain, protocol), visual TOJ (Temporal Order Judgement) task
Primary Outcome Measure Information:
Title
Disability
Description
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
Secondary Outcome Measure Information:
Title
Participation - QoL
Description
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
Title
Return to work
Description
Rate of patients returning to work at 1 year (full time and / or medical part-time)
Time Frame
12 months
Title
Body function - Pain intensity
Description
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
Title
Body function - CRPS severity score
Description
Defined by Harden et al., signs + symptoms, 0 to 16 scale ; higher score means higher severity
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged over 18, Meeting the clinical Budapest criteria, Apparition of symptoms from less than 6 months, CRPS type I or II, Capacity to understand and voluntarily sign an informed consent form in French. Exclusion Criteria: Insufficient French language skills to answer questionnaires, Personal history of CRPS at the same limb, Post-stroke CRPS type I ("shoulder-hand syndrome"), Psychiatric disorders that would interfere with the participants' ability to complete study tasks, The following hormonal situations: gravidity, lactation, gender-affirming treatment, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Berquin, PhD
Phone
+32 2 764 70 09
Email
anne.berquin@uclouvain.be
First Name & Middle Initial & Last Name or Official Title & Degree
Marc-Henri Louis, MD
Email
marc-henri.louis@uclouvain.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Berquin, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Berquin, PhD
Phone
+32 2 764 70 09
Email
anne.berquin@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Marc-Henri Louis, MD
Email
marc-henri.louis@uclouvain.be

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28715350
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.
Results Reference
background
PubMed Identifier
26524108
Citation
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.
Results Reference
background
PubMed Identifier
28573699
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.
Results Reference
background
PubMed Identifier
18573212
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.
Results Reference
background
PubMed Identifier
27023422
Citation
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.
Results Reference
background

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Prognostic Factors for Complex Regional Pain Syndrome

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