Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05431985 |
| Other study ID # |
2015 LAPORTE |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2017 |
| Est. completion date |
July 1, 2019 |
Study information
| Verified date |
June 2022 |
| Source |
University Hospital, Clermont-Ferrand |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Objective: Analgesic Opioids misuse among patients with chronic pain ranges from 0% to 50%.
The general practitioner is the first prescriber of opioid analgesics Our objective was to
validate in primary care the POMI (Prescription Opioid Misuse Index) to identify the misuse
of AOs.
Study Setting: Patients with chronic pain, taking AOs for at least 3 months, and followed in
general practice.
Study design: Psychometric study
Data Collection/Extraction methods: Eligible patients followed in general practice responded
to the POMI: Test phase. They then responded after 2 weeks: the retest. The gold standard
used was the DSM-V.
Description:
Chronic pain represents a major problem in terms of individual, quality of life, and
collective impact: cost generated by delays in treatment and care. The prevalence of chronic
pain among the general population varies from 10.1 to 55.2%. In the front line, general
practitioners (GP) are at the heart of treating pain : pain represent 43% of the reasons for
the consultation, 24% of these being for chronic pain. More than half of these patients had
exclusive care through their GP. The others are followed up in a pain assessment and
treatment center.
In 2015, nearly one in five French people (17,1%) of French people have taken opioid
treatment. The risk of opioid use disorder secondary to opioid analgesics among patients
suffering from chronic pain varies from 0% to 50%. American recommendations advocate periodic
surveillance of this opioid use disorder depending on the patient's risk factors, when
chronic opioid analgesics are prescribed. The French "Limoges" recommendations also mention a
systematic search for signs of psychological dependence during treatment and state that
treatment with strong opioids should be stopped in the event of misuse, abuse or addiction.
They recommend, on each examination, the investigation for signs of misuse or psychological
dependence (characterised by craving) as ways of monitoring that strong opioids are being
correctly used in chronic osteo-articular pain.
Identifying the misuse is a way of optimising their benefit/risk ratio
The difficulty in establishing the prevalence of misuse is due to a lack of standardization
of studies and the lack of consensus in the use of assessment tools. Several tools are
available internationally. The only diagnostic criteria available are those of the DSM-5
(Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders) or the ICD-10
which overestimate this prevalence notably by the presence of frequent tolerance and
withdrawal criteria for these patients, in the absence of misuse or addiction. Today, no
screening scale has been validated in France for primary care, but recently, the authors have
validated the POMI scale in French to screen the patients specifically followed in pain
clinic and presenting a misuse behavior of their opioid analgesic treatment. In 2015,
treatment initiation was carried out by a GP in 59.1% of cases for weak opioid and 62.9% of
cases for strong opioids and by a hospital doctor for 20.1% and 21% respectively7. Currently,
no scale was validated in primary care. A scale validated in French would make it possible to
standardize these screening practices and secure prescription both from the point of view of
the doctor and of the patient. Furthermore, this absence of a validated tool in French is
proving to be an obstacle to the development of true pharmaco-epidemiological studies on the
prevalence of the opioids misuse. The originality of this study is to assess the clinical
relevance of the french transcultural validation of the POMI scale in primary care in order
to ensure an appropriate and relevant use by all health professionals and to allow
large-scale screening for the misuse behavior of analgesic opioids.
The aim of the study was a validation of the French version of the Prescription Opioid Misuse
Index - POMI patients with chronic pain in general practitioners setting.
Secondary objective
- To study the profile of participants with misuse of opioid analgesics.
- To compare the results of this study with the previous study on patients followed in
pain clinic.
