Chronic PainPRECAPAINNCT02171936
Chronic Pain and Social Vulnerability: Prevalence and Predictive Factors of the Social Vulnerability in Evaluation and Treatment of the Pain Center (CETD)
An observational study of Chronic Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
In the care of the chronic pain in pain's department, pain consultation or Evaluation and Treatment of the Pain Center (CETD), the patients are often in a situation of physical and psychic suffering which requires a multidisciplinary follow-up. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Questionnaire EPICES (Evaluation of the Precariousness and the Disparities of Health for the Centers of Examination of Health).
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to May 2016
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients follow-up in a CETD
Who may be able to join
- Patient follow-up in a CETD, Patient of more than 18 years old, Patient having a sufficient cooperation and an understanding to conform to the imperatives of the study, Patient agreeing to give a written consent, Patient member in the social security system French.
Who cannot join
- Old Patient under age 18, Patient with cooperation and understanding not allowing conforming in a strict way to the conditions and to the tests planned by the protocol, Patient benefiting from a legal protective measure (guardianship, supervision) Unaffiliated patient in the social security system French
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
In the care of the chronic pain in pain's department, pain consultation or Evaluation and Treatment of the Pain Center (CETD), the patients are often in a situation of physical and psychic suffering which requires a multidisciplinary follow-up. So, 19 percent of the chronic painful patients lost their employment, are "disintegrated" because of their pain, this being able to provocate a loss of their financial autonomy. A large number of painful patients thus find themselves in situations of social vulnerability even of precariousness often denied and difficult to detect by the caring team. Precarity is define as " the lack of one or several securities, in particular the employment, allowing the people and the families to assume their professional, family or social obligations, and to enjoy their fundamental rights." To allow a earlier identification of the populations in deprivation situation, the questionnaire EPICES (Evaluation of the Precariousness and the Disparities of health for the Centers of Examination of Health (CES)) was administered to more than 7000 people. The individual score, indicator of the precariousness and the disparities of health, is calculated after answer to 11 questions and was calculated on about 200 000 French people. Among numerous indicators, it appears that the consumption of psychotropics or a negative perception of the health are socioeconomic indicators, mode of life and health which are prevailing according to the quintiles of the score EPICES.
This national study, on the French CETD aims is: 1 - to study prevalence of the social vulnerability even of the precariousness thanks to adapted questionnaires of which the questionnaire EPICES, 2 - to identify predictive social-economic factors which generate and amplify this circumstance, 3 - to identify the patients for whom a situation of precariousness and social vulnerability is proved true, justifying the earlier orientation towards the social worker of the Center so allowing a "global" care of the patient during the second visit
Read the detailed description
This national study is the first study on the chronic pain and the social vulnerability, as well at the level national as international because at this day there is no international publication dealing with this problem which begins to emerge in the structures setting in charge of the patients suffering of chronic pain. A recent article (Denk and al, on 2014) underlines the importance to look for the predictive factors of the chronic pain. This epidemiological study of prevalence of the social vulnerability even of the precariousness as well as predictive factors of this circumstance will allow to identify the patients with risk in a earlier way and to refer them as soon as possible for a support in the social domain. In a completely empirical way we notice important obstacles of psychosocial and societal order during the therapeutic care of the patients. This study will allow to bring important information on a troop about one thousand patients distributed on the French CETD.
- Conditions
- Chronic Pain
- Being tested
- Questionnaire EPICES (Evaluation of the Precariousness and the Disparities of Health for the Centers of Examination of Health).
- Keywords
- Pain, Precariousness, EPICES Score, CETD
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire EPICES (Evaluation of the Precariousness and the Disparities of Health for the Centers of Examination of Health).Other
| Study group | Role | What they receive |
|---|---|---|
| chronic pain | Not described Receives: Other: Questionnaire EPICES (Evaluation of the Precariousness and the Disparities of Health for the Centers of Examination of Health). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate prevalence of the precariousness and the disparities of health at the chronic painful patient in CETD by the questionnaire EPICES
Estimate prevalence of the precariousness and the disparities of health at the chronic painful patient in CETD by the questionnaire EPICES (Evaluation of the Precariousness and the Disparities of Health for the Centers of Examination of Health).
Patient which have a score EPICES ≥ 30, 2. will be considered as " vulnerable socially or precarious" and will came for a second consultation in the center of Evaluation and Treatment of the Pain, to benefit an earlier orientation and better adapted with a social worker.
Measured: At day 1
Secondary outcomes (1)
Estimation of the relation between precariousness / disparities of health and the quality of life estimated by the SF36
Measured: At day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisèle PICKERING, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171936
- Sponsor's protocol ID
- CHU-0194
- Acronym
- PRECAPAIN
- Status last verified
- Jun 2014
- First submitted
- 16 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain and Social Vulnerability: Prevalence and Predictive Factors of the Social Vulnerability in Evaluation and Treatment of the Pain Center (CETD)
- ClinicalTrials.gov ID
- NCT02171936
- Acronym / sponsor ID
- PRECAPAIN / CHU-0194
- Conditions
- Chronic Pain
- Keywords
- Pain, Precariousness, EPICES Score, CETD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 24 Jun 2014 (estimated)
- 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.
In the care of the chronic pain in pain's department, pain consultation or Evaluation and Treatment of the Pain Center (CETD), the patients are often in a situation of physical and psychic suffering which requires a multidisciplinary follow-up. So, 19 percent of the chronic painful patients lost their employment, are "disintegrated" because of their pain, this being able to provocate a loss of their financial autonomy. A large number of painful patients thus find themselves in situations of social vulnerability even of precariousness often denied and difficult to detect by the caring team. Precarity is define as " the lack of one or several securities, in particular the employment, allowing the people and the families to assume their professional, family or social obligations, and to enjoy their fundamental rights." To allow a earlier identification of the populations in deprivation situation, the questionnaire EPICES (Evaluation of the Precariousness and the Disparities of health for the Centers of Examination of Health (CES)) was administered to more than 7000 people. The individual score, indicator of the precariousness and the disparities of health, is calculated after answer to 11 questions and was calculated on about 200 000 French people. Among numerous indicators, it appears that the consumption of psychotropics or a negative perception of the health are socioeconomic indicators, mode of life and health which are prevailing according to the quintiles of the score EPICES.
This national study, on the French CETD aims is: 1 - to study prevalence of the social vulnerability even of the precariousness thanks to adapted questionnaires of which the questionnaire EPICES, 2 - to identify predictive social-economic factors which generate and amplify this circumstance, 3 - to identify the patients for whom a situation of precariousness and social vulnerability is proved true, justifying the earlier orientation towards the social worker of the Center so allowing a "global" care of the patient during the second visit
Detailed description
This national study is the first study on the chronic pain and the social vulnerability, as well at the level national as international because at this day there is no international publication dealing with this problem which begins to emerge in the structures setting in charge of the patients suffering of chronic pain. A recent article (Denk and al, on 2014) underlines the importance to look for the predictive factors of the chronic pain. This epidemiological study of prevalence of the social vulnerability even of the precariousness as well as predictive factors of this circumstance will allow to identify the patients with risk in a earlier way and to refer them as soon as possible for a support in the social domain. In a completely empirical way we notice important obstacles of psychosocial and societal order during the therapeutic care of the patients. This study will allow to bring important information on a troop about one thousand patients distributed on the French CETD.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic pain | – | Other: Questionnaire EPICES (Evaluation of the Precariousness and the Disparities of Health for the Centers of Examination of Health). |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients follow-up in a CETD
Key inclusion criteria (1 listed)
- Patient follow-up in a CETD, Patient of more than 18 years old, Patient having a sufficient cooperation and an understanding to conform to the imperatives of the study, Patient agreeing to give a written consent, Patient member in the social security system French.
Key exclusion criteria (1 listed)
- Old Patient under age 18, Patient with cooperation and understanding not allowing conforming in a strict way to the conditions and to the tests planned by the protocol, Patient benefiting from a legal protective measure (guardianship, supervision) Unaffiliated patient in the social security system French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire EPICES (Evaluation of the Precariousness and the Disparities of Health for the Centers of Examination of Health). | Other | chronic pain |
Primary outcome
Estimate prevalence of the precariousness and the disparities of health at the chronic painful patient in CETD by the questionnaire EPICES
Time frame: At day 1
Estimate prevalence of the precariousness and the disparities of health at the chronic painful patient in CETD by the questionnaire EPICES (Evaluation of the Precariousness and the Disparities of Health for the Centers of Examination of Health). Patient which have a score EPICES ≥ 30, 2. will be considered as " vulnerable socially or precarious" and will came for a second consultation in the center of Evaluation and Treatment of the Pain, to benefit an earlier orientation and better adapted with a social worker.
1 secondary outcome
Estimation of the relation between precariousness / disparities of health and the quality of life estimated by the SF36
Time frame: At day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
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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.
Gisèle PICKERING principal investigator
University Hospital, Clermont-Ferrand
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 Pain, run by University Hospital, Clermont-Ferrand 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 1 inclusion and 1 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 24 Jun 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate prevalence of the precariousness and the disparities of health at the chronic painful patient in CETD by the questionnaire EPICES (time frame: At day 1). 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 24 Jun 2014.