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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04913051
Other study ID # CHM-2020/S44/15
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 20, 2021
Est. completion date May 20, 2023

Study information

Verified date May 2021
Source Centre Hospitalier le Mans
Contact Christelle JADEAU
Phone 02 44 71 07 81
Email cjadeau@ch-lemans.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date May 20, 2023
Est. primary completion date May 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient volunteers over 18 years of age - Diagnosis of CRPS according to the Budapest criteria - Referred to pain assessment and treatment center Exclusion Criteria: - 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

Study Design


Locations

Country Name City State
France Centre Hospitalier Du Mans Le Mans

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier le Mans

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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