Last update : 06/23/2015 | Version : 1 | ID : 9205
General | |
Identification | |
Detailed name | Cross-sectional Survey on The Prevalence of Chronic and Neuropathic Pain Among Diabetics |
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL approval; Ile de France CPP |
General Aspects | |
Medical area |
Endocrinology and metabolism Neurology |
Health determinants |
Genetic Medicine |
Keywords | nerve, intensity, sensitivity, pain |
Scientific investigator(s) (Contact) | |
Name of the director | Didier |
Surname | Bouhassira |
Address | 9 Avenue Charles De Gaulle Centre Evaluation Traitement Douleur 92100 Boulogne Billancourt |
Phone | +33 (0)1 49 09 44 34 |
didier.bouhassira@apr.aphp.fr ; didier.bouhassira@inserm.fr | |
Unit | U987 Physiopathologie et pharmacologie clinique de la douleur |
Organization | Institut National de la Santé et de la Recherche Médicale - |
Collaborations | |
Funding | |
Funding status |
Private |
Details | Pfizer Laboratory |
Governance of the database | |
Sponsor(s) or organisation(s) responsible | Institut National de la Santé et de la Recherche Médicale - Inserm |
Organisation status |
Public |
Additional contact | |
Main features | |
Type of database | |
Type of database |
Study databases |
Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
Database recruitment is carried out as part of an interventional study |
No |
Additional information regarding sample selection. | Study subjects were selected over a period of 3 months by 85 diabetes specialists working in hospitals or clinics in France. |
Database objective | |
Main objective | To estimate the prevalence of chronic and neuropathic pain in patients with type 1 or 2 diabetes. To assess the relationship between neuropathic and polyneuropathic pain. |
Inclusion criteria |
- male and female
- adult - with type 1 or 2 diabetes |
Population type | |
Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
Population covered |
Sick population |
Gender |
Male Woman |
Geography area |
National |
Detail of the geography area | France |
Data collection | |
Dates | |
Date of first collection (YYYY or MM/YYYY) | 2013 |
Size of the database | |
Size of the database (number of individuals) |
[500-1000[ individuals |
Details of the number of individuals | 766 patients - 297 patients with type 1 diabetes - 469 patients with type 2 diabetes |
Data | |
Database activity |
Data collection completed |
Type of data collected |
Declarative data Paraclinical data |
Declarative data (detail) |
Paper self-questionnaire |
Details of collected declarative data | - DN4 and MNSI (Michigan Neuropathy Screening Instrument) questionnaires to estimate the probability of neuropathic pain in patients. - Patient quality of life questionnaire where the state of anxiety, depression and quality of sleep of interviewed patients can be assessed. |
Paraclinical data (detail) | Monofilament sensitivity test. |
Presence of a biobank |
No |
Health parameters studied |
Quality of life/health perception |
Procedures | |
Data collection method | Patients responded to questionnaires and tests on intensity and description of perceived pain, tactile sensitivity in the feet and legs and quality of sleep. |
Participant monitoring |
No |
Links to administrative sources |
No |
Promotion and access | |
Promotion | |
Link to the document | http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3772849/ |
Access | |
Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge. |
Access to aggregated data |
Access on specific project only |
Access to individual data |
Access on specific project only |
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