Chronic PainPOMINCT04979364
French Version of POMI Scale
An observational study of Chronic Pain and Opioid Misuse, run by University Hospital, Clermont-Ferrand.
Trial summary
French translation and validation of the Prescription Opioid Misuse Index scale (POMI), a brief questionnaire to assess opioid prescription misuse. In view of the increase in the prescription of opioid analgesics for chronic non-cancer pain (CNCP), this tool is particularly interesting to use during medical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Opioid Misuse
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 31 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chonic non-cancer pain.
Who may be able to join
- patients aged 18 or more, suffered from chronic non-cancer pain for at least 6 months, with at least one analgesic opioid daily for 3 months, and follow in pain clinic.
Who cannot join
- inability to read or understand questionnaires alone, cancer, and impossibility to do test and retest questionnaires.
About this study
Official title: Transcultural Validation of a French Version of the Prescription Opioid Misuse Idex Scale (POMI-5F)
French translation and validation of the Prescription Opioid Misuse Index scale (POMI), a brief questionnaire to assess opioid prescription misuse. In view of the increase in the prescription of opioid analgesics for chronic non-cancer pain (CNCP), this tool is particularly interesting to use during medical consultations to screen misuse in opioids user patients. We conducted an observational, prospective and multicenter psychometric study with a cross-cultural validation in 154 CNCP patients treated by opioid at least from 3 months, in two pain clinics.
Read the detailed description
Chronic pain prevalence in the general population was estimated at 31% in the world, which makes it a major public health problem, not only because of its enormous impact on patients' quality of life, but also because of its significant economic impact on society, with direct and indirect costs. Despite the lack of scientific evidence demonstrating their long-term benefits, analgesic opioids are largely used for treating chronic non-cancer pain (CNCP) lead to an increase of opioid use in recent decades in developed countries. Indeed, worldwide, opioid analgesic prescription use more than doubled from 2001 to 2013, most significantly in North America and in Western and Central Europe. Between years 2004 and 2017 in France, while overall analgesic opioid prescription use in the general population decreased by 8.9%, the used strong opioids increased by 104%. The same finding about increase in the use strong opioids was made in USA, Canada and UK. However, the use of opioid analgesics is not without risk, several international studies showed an increase opioid use disorders, hospitalizations and deaths related to the use of opioid analgesics. In France, rates of prescribed opioid-related hospital admissions increased by 167% from 2000 to 2017 and opioid-related deaths significantly increased by 146% (1,3 à 3,2 deaths / 1,000,000 habitants from 2000 to 2015). A similar observation can be made in the United States, where deaths from prescription opioid overdose have risen sharply in recent years, but in a much higher proportion than in France (in 2016 in the U.S., more than 42,000 overdose deaths, or an annual prevalence of 133 deaths/1,000,000 population).
In the context of CNCP, opioid analgesics are subject to increasing misuse in relation to a greater number of prescriptions but also through other sources of obtaining (doctor shopping) hat may contribute to the increase in risks associated with the use of opioid analgesics (hospitalization, death). Few studies in France, assessed the misuse of analgesic opioids, based on the evaluation of "doctor shopping" from healthcare databases, and particularly, Chenaf et al., showed an increase of analgesic opioids shopping behavior by 34%, between 2004 to 0.67% in 2017. It is therefore important to be able to identify analgesic opioid misuse. Actually Prescription Opioid Misuse Index (POMI) scale was validated in 2008 by American team in 137 patients recruited from community substance abuse treatment programs, regional jails, pain clinics and private internal medicine practices.
The primary objective was the cross-cultural validation of French version of an opioid analgesic misuse screening scale (POMI) in chronic pain patients in primary care. The secondary objective was the assessment of the relationship between pain intensity and analgesic opioid misuse.
- Conditions
- Chronic Pain, Opioid Misuse
- Medical subject headings
- Chronic Pain, Opioid-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
psychometric properties of POMI scale
Construct validity, internal consistency, test-retest reliability, and convergent validity of POMI scale French version (POMI-5F).
POMI scale is a self-evaluation scale with 8 items scored 0 (absence) or 1 (presence). The questionnaire is presented in 8 questions, of which 6 are used to calculate a score which is the sum of positive answers; when this score reaches 2, it's considered as positive and describe a misuse.
Measured: Once. Day 1
psychometric properties of POMI scale
Construct validity, internal consistency, test-retest reliability, and convergent validity of POMI scale French version (POMI-5F).
POMI scale is a self-evaluation scale with 8 items scored 0 (absence) or 1 (presence). The questionnaire is presented in 8 questions, of which 6 are used to calculate a score which is the sum of positive answers; when this score reaches 2, it's considered as positive and describe a misuse.
Measured: Once. At 2 to 4 weeks (Re-TEST phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Sep 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Toulouse
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979364
- Sponsor's protocol ID
- POMI
- Acronym
- POMI
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2021
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcultural Validation of a French Version of the Prescription Opioid Misuse Idex Scale (POMI-5F)
- ClinicalTrials.gov ID
- NCT04979364
- Acronym / sponsor ID
- POMI / POMI
- Conditions
- Chronic Pain, Opioid Misuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- University Hospital, Toulouse
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 28 Jul 2021 (actual)
- 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.
French translation and validation of the Prescription Opioid Misuse Index scale (POMI), a brief questionnaire to assess opioid prescription misuse. In view of the increase in the prescription of opioid analgesics for chronic non-cancer pain (CNCP), this tool is particularly interesting to use during medical consultations to screen misuse in opioids user patients. We conducted an observational, prospective and multicenter psychometric study with a cross-cultural validation in 154 CNCP patients treated by opioid at least from 3 months, in two pain clinics.
Detailed description
Chronic pain prevalence in the general population was estimated at 31% in the world, which makes it a major public health problem, not only because of its enormous impact on patients' quality of life, but also because of its significant economic impact on society, with direct and indirect costs. Despite the lack of scientific evidence demonstrating their long-term benefits, analgesic opioids are largely used for treating chronic non-cancer pain (CNCP) lead to an increase of opioid use in recent decades in developed countries. Indeed, worldwide, opioid analgesic prescription use more than doubled from 2001 to 2013, most significantly in North America and in Western and Central Europe. Between years 2004 and 2017 in France, while overall analgesic opioid prescription use in the general population decreased by 8.9%, the used strong opioids increased by 104%. The same finding about increase in the use strong opioids was made in USA, Canada and UK. However, the use of opioid analgesics is not without risk, several international studies showed an increase opioid use disorders, hospitalizations and deaths related to the use of opioid analgesics. In France, rates of prescribed opioid-related hospital admissions increased by 167% from 2000 to 2017 and opioid-related deaths significantly increased by 146% (1,3 à 3,2 deaths / 1,000,000 habitants from 2000 to 2015). A similar observation can be made in the United States, where deaths from prescription opioid overdose have risen sharply in recent years, but in a much higher proportion than in France (in 2016 in the U.S., more than 42,000 overdose deaths, or an annual prevalence of 133 deaths/1,000,000 population).
In the context of CNCP, opioid analgesics are subject to increasing misuse in relation to a greater number of prescriptions but also through other sources of obtaining (doctor shopping) hat may contribute to the increase in risks associated with the use of opioid analgesics (hospitalization, death). Few studies in France, assessed the misuse of analgesic opioids, based on the evaluation of "doctor shopping" from healthcare databases, and particularly, Chenaf et al., showed an increase of analgesic opioids shopping behavior by 34%, between 2004 to 0.67% in 2017. It is therefore important to be able to identify analgesic opioid misuse. Actually Prescription Opioid Misuse Index (POMI) scale was validated in 2008 by American team in 137 patients recruited from community substance abuse treatment programs, regional jails, pain clinics and private internal medicine practices.
The primary objective was the cross-cultural validation of French version of an opioid analgesic misuse screening scale (POMI) in chronic pain patients in primary care. The secondary objective was the assessment of the relationship between pain intensity and analgesic opioid misuse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chonic non-cancer pain.
Key inclusion criteria (1 listed)
- patients aged 18 or more, suffered from chronic non-cancer pain for at least 6 months, with at least one analgesic opioid daily for 3 months, and follow in pain clinic.
Key exclusion criteria (1 listed)
- inability to read or understand questionnaires alone, cancer, and impossibility to do test and retest questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
psychometric properties of POMI scale
Time frame: Once. Day 1
Construct validity, internal consistency, test-retest reliability, and convergent validity of POMI scale French version (POMI-5F). POMI scale is a self-evaluation scale with 8 items scored 0 (absence) or 1 (presence). The questionnaire is presented in 8 questions, of which 6 are used to calculate a score which is the sum of positive answers; when this score reaches 2, it's considered as positive and describe a misuse.
psychometric properties of POMI scale
Time frame: Once. At 2 to 4 weeks (Re-TEST phase)
Construct validity, internal consistency, test-retest reliability, and convergent validity of POMI scale French version (POMI-5F). POMI scale is a self-evaluation scale with 8 items scored 0 (absence) or 1 (presence). The questionnaire is presented in 8 questions, of which 6 are used to calculate a score which is the sum of positive answers; when this score reaches 2, it's considered as positive and describe a misuse.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Opioid Misuse, run by University Hospital, Clermont-Ferrand.
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: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychometric properties of POMI scale (time frame: Once. Day 1). The study lists 2 primary outcomes in all. 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 15 Mar 2022.