ITMO public health
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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