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Complex Regional Pain SyndromesCRPSPrognosisNCT05337501

Prognostic Factors for Complex Regional Pain Syndrome

A study testing Collecting data in people with Complex Regional Pain Syndromes, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Complex Regional Pain Syndromes
What is being tested?
Collecting data
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
1 siteBelgium
Study dates
28 Mar 2022to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

About this study

Official title: Prognostic Factors for Complex Regional Pain Syndrome: a Longitudinal Study

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.
Read more

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.
Read the 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.

Being tested
Collecting data
Medical subject headings
Complex Regional Pain Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collecting dataOther

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

Study groups in NCT05337501
Study groupRoleWhat they receive
Patients groupExperimentalNot described
Receives: Other: Collecting data

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (4)

  1. 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

    Measured: 12 months

  2. Return to work

    Rate of patients returning to work at 1 year (full time and / or medical part-time)

    Measured: 12 months

  3. 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)

    Measured: 12 months

  4. Body function - CRPS severity score

    Defined by Harden et al., signs + symptoms, 0 to 16 scale ; higher score means higher severity

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start28 Mar 2022
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective longitudinal observational study
Masking
None (open label)
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05337501
Sponsor's protocol ID
2022/28FEV/093
Acronym
CRPSPrognosis
Status last verified
Apr 2024
First submitted
6 Apr 2022
Last updated
1 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28715350

  • 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.

    PubMed 26524108

  • 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.

    PubMed 28573699

  • 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.

    PubMed 18573212

  • 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.

    PubMed 27023422

  • 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.

    PubMed 41065599

Questions about this trial

What is this clinical trial studying?

A study testing Collecting data in people with Complex Regional Pain Syndromes, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disability (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05337501, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.

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