NCT05337501

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

2.8 years

First QC Date

April 6, 2022

Last Update Submit

April 29, 2024

Conditions

Complex Regional Pain Syndromes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Participation - QoL

    12 months

  • Return to work

    12 months

  • Body function - Pain intensity

    12 months

  • Body function - CRPS severity score

    12 months

Study Arms (1)

Patients group

EXPERIMENTAL
Other: Collecting data

Interventions

Collecting dataOTHER

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

Patients group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

Location

Related Publications (6)

  • 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.

    PMID: 28715350BACKGROUND

  • 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.

    PMID: 26524108BACKGROUND

  • 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.

    PMID: 28573699BACKGROUND

  • 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.

    PMID: 18573212BACKGROUND

  • 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.

    PMID: 27023422BACKGROUND

  • 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.

    PMID: 41065599DERIVED

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Study Officials

  • Anne Berquin, PhD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Prospective longitudinal observational study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 20, 2022

Study Start

March 28, 2022

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

May 1, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)