ITMO public health
Last update : 01/01/2018 | Version : 1 | ID : 111
| General | |
| Identification | |
| Detailed name | Comorbidities associated with peripheral neuropathic pain (PNP) |
| Sign or acronym | ORBIT |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL N° 906289 |
| General Aspects | |
| Medical area |
Neurology |
| Others (details) | Peripheral neuropathic pain (PNP) |
| Scientific investigator(s) (Contact) | |
| Name of the director | Millet |
| Surname | Véronique |
| Address | 23-25 avenue du Dr Lannelongue, 75668 paris cedex 14 |
| Phone | +33 (0)1 58 07 34 12 |
| veronique.millet@pfizer.com | |
| Unit | Pfizer |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Pfizer |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Pfizer |
| Organisation status |
Both |
| 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. | Recruitment through participating doctors |
| Database objective | |
| Main objective |
Primary: - Evaluate the frequency of anxiety and mood disturbances and the degree of sleeping disorders in patients monitored for PNP Secondary: - Describe the links between the components of the PNP and the existence of anxiety, mood disturbances and the degree of sleeping disorders, - Describe the relations between the components of PNP, anxiety, sleeping disorders, mood disturbances on the one hand and the quality of life on the other hand, - Describe the relation between the components of the PNP, the existence of anxiety and mood disturbances, the degree of sleep disorders on the one hand and the current drug care of patients on the other hand. |
| Inclusion criteria |
Patients > 18 years, - Peripheral neuropathic pain (in relation with a lesion of the peripheral nervous system). - Intensity of the pain > 3 on the NVS, - Radiculalgia without lumbar pain or with lumbar pain of which the intensity of the pain is < 3 on the NVS (intensity of the lumbar pain from 0 to 2), - Through general neurology: patient consulting for his PNP or for the etiology of this PNP, - Through home consultation: patient consulting for a PNP for the 1st or 2nd consultation. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Metropolitan France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2006 |
| Date of last collection (YYYY or MM/YYYY) | 2008 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 195 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Face to face interview |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health care consumption and services |
| Care consumption (detail) |
Medical/paramedical consultation |
| Procedures | |
| Data collection method | Paper CRF |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | methods for accessing the database are currently being defined |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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