NCT04913051

Brief Summary

Chronic Regional Pain Syndrome (CRPS) is a chronic disabling disease. Patients present a variable picture associating pain localized to an articular or peri-articular region, motor and vasomotor disorders and trophic disorders. Its pathophysiology, still poorly understood to this day, results from local inflammatory phenomena complicated by peripheral sensitization and central spinal and cerebral sensitization. The diagnosis is made difficult by the fluctuating nature of the symptoms and the absence of specific complementary examination. The treatment of CRPS is symptomatic and requires multidisciplinary care. CRPS is responsible for an alteration in the patient's quality of life. This pathology has a global impact because it affects not only the biomedical sphere but also the socio-family, professional and psychological spheres. The investigators hypothesize that multidisciplinary intervention in the Day Hospital would improve the quality of life of patients with CRPS. The investigators also think that the passage in Day Hospital would make it possible to improve the pains, the functionality of the affected limb as well as the satisfaction of the patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 21, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
Last Updated

October 5, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

May 21, 2021

Last Update Submit

September 28, 2021

Conditions

Keywords

Chronic Regional Pain Syndromeday hospitalChronic Pain Unit

Outcome Measures

Primary Outcomes (2)

  • Evaluate impact of day hospital care on quality of life

    Impact of quality of life was assessed by questionnaire Short Form Health Survey (SF36). A score ranging from 0 to 100 is obtained. A low score reflects a perception of poor health, loss of function, presence of pain.

    3 months after day hospital

  • Evaluate impact of day hospital care on quality of life

    Impact of quality of life was assessed by questionnaire Short Form Health Survey (SF36). A score ranging from 0 to 100 is obtained. A low score reflects a perception of poor health, loss of function, presence of pain.

    6 months after day hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Chronic Regional Pain Syndrome referred to the Chronic Pain Facility for the first time

You may qualify if:

  • Patient volunteers over 18 years of age
  • Diagnosis of CRPS according to the Budapest criteria
  • Referred to pain assessment and treatment center

You may not qualify if:

  • Patients unable to express their wishes or understand the protocol
  • Diagnosis of CRPS not meeting Budapest criteria
  • Patients previously seen at pain assessment and treatment center for the care of CRPS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Du Mans

Le Mans, 72000, France

RECRUITING

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular Diseases

Central Study Contacts

Christelle JADEAU

CONTACT

Nathalie DEROUET, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2021

First Posted

June 4, 2021

Study Start

May 20, 2021

Primary Completion

May 20, 2023

Study Completion

May 20, 2023

Last Updated

October 5, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations