Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353100
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-02-05
Brief Title:
Chronic Pain in the General Population of Chile
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Pontificia Universidad Catolica de Chile
Study Overview
Official Title:
Chronic Pain in the General Population of Chile Longitudinal Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RDC
Brief Summary:
The present study seeks to follow up the cohort of adults representative of Chiles urban population whose levels of chronic pain were evaluated in March 2023 baseline as part of the Mental Health Thermometer MHT study The study consists of a 12 month follow-up telephone interview to assess parameters of chronic pain CP and subtypes mental and physical health lifestyle and adversity and work characteristics
The study objectives are as follows
1 Estimate the prevalence of CP and subtypes in the general population
2 Explore the association between mental health indicators perceived work stress and presence of CP in the population
3 Investigate the impact of CP functional occupational and social among the subset of participants reporting CP
4 Describe the use of management strategies in those who suffer from CP
The study objectives are as follows
1 Estimate the prevalence of CP and subtypes in the general population
2 Explore the association between mental health indicators perceived work stress and presence of CP in the population
3 Investigate the impact of CP functional occupational and social among the subset of participants reporting CP
4 Describe the use of management strategies in those who suffer from CP
Detailed Description:
I Aims of the study
1 Estimate the prevalence of chronic pain CP and subtypes in the
2 Explore the association between mental health indicators perceived work stress and the presence of CP in the urban population of Chile
3 Asses the functional occupational and social impact of CP in Chiles urban population reporting CP
4 Describe the use of management strategies in those who suffer from CP
II Design
The design is longitudinal prospective and involves following up the same group of participants from the MHT study to monitor their mental health and CP parameters
III Study variables include
31 Main outcome measures instrument Presence of chronic pain in the last 3 months Severity of chronic pain Chronic pain grade questionnaire CPG chronic pain interference in daily activities social activities and work CPG depression Patient Health Questionnaire PHQ-9 anxiety General Anxiety Disorder GAD-7 32 Secondary outcome measures chronic pain management strategies migraine disability Migraine Disability Assessment MIDAS neuropathic pain Neuropathic pain DN4 Questionnaire DN4 fibromyalgia Fibromyalgia Survey Questionnaire FSQ insomnia Insomnia Severity Index ISI loneliness 3-item UCLA Loneliness Scale R-UCLA 33 Variables of interest job-relates stress Copenhagen Burnout Inventory CBI childhood adversity Adverse childhood experiences ACE negative life events
IV Groups
For the longitudinal analysis participants will be classified into four groups
Group 1 no pain participants who do not declare CP at baseline or follow-up
Group 2 incident participants who do not declare CP at baseline but declare it at follow-up
Group 3 remitted participants who declare CP at baseline but do not declare it at follow-up
Group 4 chronic pain at follow-up participants who declare CP at baseline and follow-up
V Analysis plan
51 Cross-sectional analysis at follow-up
Prevalence of CP will be calculated with 95 confidence interval CI for the Chilean urban population by sex age group and employment status aim 1
Prevalences of the most common CP syndromes ie migraine fibromyalgia neuropathic pain with 96 CI will also be calculated
In the subset of the population with CP descriptive analyzes will be carried out percentages means and standard deviation of the interference levels aim 3 and chronic pain management strategies aim 4 by sex age group and employment status
Calculation of Odds Ratios ORs with 95 CI for the main mental health variables associated with the presence of CI ie symptoms of depression and anxiety and for work variables ie work-related stress using logistic regression adjusting for age sex physical health characteristics aim 2
52 Longitudinal analysis baseline and follow-up
The database will be integrated with the baseline data and based on the distribution of certain sociodemographic and health variables in the two times an attrition analysis will be carried out to conclude on the selective loss of subjects
Four groups will be created according to the pain trajectory between the two measurement points see group section and the proportion of new cases in the 12 months will be calculated ie annual incidence
The difference in the chronic pain intensity reported at the measurement points will be calculated
Several multilevel models will be analyzed to examine the relationship between mental health PHQ-9 and GAD- 7 sleep difficulties ISI perception of loneliness UCLA-R health variables alcohol consumption tobacco body mass and work variables ie job satisfaction work-related stress and changes in the magnitude of perceived CP at 12 months using linear and non-linear mixed effects models aim 3
1 Estimate the prevalence of chronic pain CP and subtypes in the
2 Explore the association between mental health indicators perceived work stress and the presence of CP in the urban population of Chile
3 Asses the functional occupational and social impact of CP in Chiles urban population reporting CP
4 Describe the use of management strategies in those who suffer from CP
II Design
The design is longitudinal prospective and involves following up the same group of participants from the MHT study to monitor their mental health and CP parameters
III Study variables include
31 Main outcome measures instrument Presence of chronic pain in the last 3 months Severity of chronic pain Chronic pain grade questionnaire CPG chronic pain interference in daily activities social activities and work CPG depression Patient Health Questionnaire PHQ-9 anxiety General Anxiety Disorder GAD-7 32 Secondary outcome measures chronic pain management strategies migraine disability Migraine Disability Assessment MIDAS neuropathic pain Neuropathic pain DN4 Questionnaire DN4 fibromyalgia Fibromyalgia Survey Questionnaire FSQ insomnia Insomnia Severity Index ISI loneliness 3-item UCLA Loneliness Scale R-UCLA 33 Variables of interest job-relates stress Copenhagen Burnout Inventory CBI childhood adversity Adverse childhood experiences ACE negative life events
IV Groups
For the longitudinal analysis participants will be classified into four groups
Group 1 no pain participants who do not declare CP at baseline or follow-up
Group 2 incident participants who do not declare CP at baseline but declare it at follow-up
Group 3 remitted participants who declare CP at baseline but do not declare it at follow-up
Group 4 chronic pain at follow-up participants who declare CP at baseline and follow-up
V Analysis plan
51 Cross-sectional analysis at follow-up
Prevalence of CP will be calculated with 95 confidence interval CI for the Chilean urban population by sex age group and employment status aim 1
Prevalences of the most common CP syndromes ie migraine fibromyalgia neuropathic pain with 96 CI will also be calculated
In the subset of the population with CP descriptive analyzes will be carried out percentages means and standard deviation of the interference levels aim 3 and chronic pain management strategies aim 4 by sex age group and employment status
Calculation of Odds Ratios ORs with 95 CI for the main mental health variables associated with the presence of CI ie symptoms of depression and anxiety and for work variables ie work-related stress using logistic regression adjusting for age sex physical health characteristics aim 2
52 Longitudinal analysis baseline and follow-up
The database will be integrated with the baseline data and based on the distribution of certain sociodemographic and health variables in the two times an attrition analysis will be carried out to conclude on the selective loss of subjects
Four groups will be created according to the pain trajectory between the two measurement points see group section and the proportion of new cases in the 12 months will be calculated ie annual incidence
The difference in the chronic pain intensity reported at the measurement points will be calculated
Several multilevel models will be analyzed to examine the relationship between mental health PHQ-9 and GAD- 7 sleep difficulties ISI perception of loneliness UCLA-R health variables alcohol consumption tobacco body mass and work variables ie job satisfaction work-related stress and changes in the magnitude of perceived CP at 12 months using linear and non-linear mixed effects models aim 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None