Chronic Regional Pain SyndromeNCT04913051
Interest of Day Hospital Care for Patients With Chronic Regional Pain Syndrome Referred to the Chronic Pain Unit for the First Time
An observational study of Chronic Regional Pain Syndrome, run by Centre Hospitalier le Mans at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Regional Pain Syndrome
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2021to 27 Oct 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Chronic Regional Pain Syndrome referred to the Chronic Pain Facility for the first time
Who may be able to join
- Patient volunteers over 18 years of age
- Diagnosis of CRPS according to the Budapest criteria
- Referred to pain assessment and treatment center
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Chronic Regional Pain Syndrome
- Keywords
- Chronic Regional Pain Syndrome, day hospital, Chronic Pain Unit
- Medical subject headings
- Complex Regional Pain Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months after day hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start3 Jun 2021
- Primary completion27 Oct 2022
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Regional Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913051
- Sponsor's protocol ID
- CHM-2020/S44/15
- Status last verified
- Jun 2026
- First submitted
- 21 May 2021
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Day Hospital Care for Patients With Chronic Regional Pain Syndrome Referred to the Chronic Pain Unit for the First Time
- ClinicalTrials.gov ID
- NCT04913051
- Acronym / sponsor ID
- CHM-2020/S44/15
- Conditions
- Chronic Regional Pain Syndrome
- Keywords
- Chronic Regional Pain Syndrome, day hospital, Chronic Pain Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Chronic Regional Pain Syndrome referred to the Chronic Pain Facility for the first time
Key inclusion criteria (3 listed)
- Patient volunteers over 18 years of age
- Diagnosis of CRPS according to the Budapest criteria
- Referred to pain assessment and treatment center
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate impact of day hospital care on quality of life
Time frame: 3 months after day hospital
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.
Evaluate impact of day hospital care on quality of life
Time frame: 6 months after day hospital
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Regional Pain Syndrome, run by Centre Hospitalier le Mans at 1 site in France.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 1 Jul 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate impact of day hospital care on quality of life (time frame: 3 months after day hospital). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2026.