Chronic PainRDCNCT06353100
Chronic Pain in the General Population of Chile
An observational study of Chronic Pain and Migraine Disability, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The present study seeks to follow up the cohort of adults representative of Chile's urban population whose levels of chronic pain were evaluated in March 2023 (baseline) as part of the Mental Health Thermometer (MHT) study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Migraine Disability, Neuropathic Pain
- How many people
- 2,365 participants
- Where
- 1 siteChile
- Study dates
- 1 Jan 2023to 25 Sep 2025
- 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: Community survey in Chile
Who may be able to join
- General population
- Residence in urban areas
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Pain in the General Population of Chile: Longitudinal Study
The present study seeks to follow up the cohort of adults representative of Chile's 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:
- Estimate the prevalence of CP and subtypes in the general population
- Explore the association between mental health indicators, perceived work stress and presence of CP in the population.
- Investigate the impact of CP (functional, occupational and social) among the subset of participants reporting CP
- Describe the use of management strategies in those who suffer from CP.
Read the detailed description
- Aims of the study:
- Estimate the prevalence of chronic pain (CP) and subtypes in the
- Explore the association between mental health indicators, perceived work stress and the presence of CP in the urban population of Chile.
- Asses the functional, occupational and social impact of CP in Chile´s urban population reporting CP.
- 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:
3.1. 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) 3.2. 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) 3.3. 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
- Analysis plan:
5.1. 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 (i.e. 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 (i.e. symptoms of depression and anxiety) and for work variables (i.e. work-related stress), using logistic regression, adjusting for age, sex, physical health characteristics (aim 2).
5.2. 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 (i.e. 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 (i.e. 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).
- Conditions
- Chronic Pain, Migraine Disability, Neuropathic Pain, Fibromyalgia, Depression, Anxiety, Self Harm
- Keywords
- Chronic pain, Depression, Anxiety, Incidence, Prevalence
- Medical subject headings
- Chronic Pain, Neuralgia, Fibromyalgia, Depression, Anxiety Disorders, Self-Injurious Behavior, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal analysis group 1 (no pain) | Participants (general population residing in urban areas of Chile aged 18 years or more) not reporting chronic pain in march 2023 or march 2024 | |
| Longitudinal analysis group 2 (incident chronic pain) | Participants (general population residing in urban areas of Chile aged 18 years or more) not reporting chronic pain in march 2023 but reporting chronic pain in march 2024 | |
| Longitudinal analysis group 3 (remitted chronic pain) | Participants (general population residing in urban areas of Chile aged 18 years or more) reporting chronic pain in march 2023 but not reporting it in march 2024 | |
| Longitudinal analysis group 4 (chronic pain at follow up) | Participants (general population residing in urban areas of Chile aged 18 years or more) reporting chronic pain in march 2023 and march 2024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic pain (past 3 months)
Participants will be asked "Have you had constant or frequent pain [most of the day] during the past 3 months?" and asked to identify the average and maximum intensity of pain in that period using a visual analogue scale (VAS) from 0 to 10. Only participants with an average pain of 4 or more will be classified as having significant chronic pain.
Measured: Baseline and 12-month follow-up
Depression (2 weeks)
As measured by the Patient Health Questionnaire (PHQ-9). Total scores on the PHQ-9 range from 0 to 27 and higher scores indicate higher symptoms of depression.
Measured: Baseline and 12-month follow-up
Anxiety (2 weeks)
As measured by the General Anxiety Disorder (GAD-7). Total scores on the GAD-7 range from 0 to 21 and higher scores indicate higher symptoms of anxiety.
Measured: Baseline and 12-month follow-up
Secondary outcomes (6)
Migraine Disability
As measured by the MIDAS (Migraine Disability Assessment). Total scores on the MIDAS range from 0 to 20 and higher scores indicate higher disability.
Measured: 12-month follow-up
Neuropathic Pain
As measured by the DN4 (Neuropathic pain DN4 Questionnaire). Total scores on the DN4 range from 0 to 10 and Scores ≥ 4/10 indicate neuropathic pain.
Measured: Baseline and 12-month follow-up
Fibromyalgia
As measured by the Fibromyalgia Survey Questionnaire (FSQ). The possible score ranges from 0 to 31 points. A score equal to or greater than 13 points is consistent with a diagnosis of fibromyalgia.
Measured: 12-month follow-up
Self harm (2 weeks)
As measured by item 9 (Thoughts that you would be better off dead or of hurting yourself in some way) of the Patient Health Questionnaire (PHQ-9).
Measured: Baseline and 12-month follow-up
Insomnia (2 weeks)
As measured by the Insomnia Severity Index (ISI). Responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia.
Measured: Baseline and 12-month follow-up
Loneliness
As measured by the 3-item University of California, Los Angeles Loneliness Scale (R-UCLA). Total scores range from 3 to 9 and higher scores indicate higher perceived loneliness.
Measured: Baseline and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Jan 2023
- Primary completion30 Apr 2025
- Study completion25 Sep 2025
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 Pontificia Universidad Catolica de ChileThe 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
- 2,365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Chilean Safety Association (ACHS)
- Responsible party
- Sponsor
- Investigators
- Antonia Errazuriz, PhD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353100
- Sponsor's protocol ID
- 230602006
- Acronym
- RDC
- Status last verified
- Jan 2024
- First submitted
- 5 Feb 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymized database and codebook will be made available to researcher in the Dataverse website
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain in the General Population of Chile: Longitudinal Study
- ClinicalTrials.gov ID
- NCT06353100
- Acronym / sponsor ID
- RDC / 230602006
- Conditions
- Chronic Pain, Migraine Disability, Neuropathic Pain, Fibromyalgia, Depression, Anxiety, Self Harm
- Keywords
- Chronic pain, Depression, Anxiety, Incidence, Prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,365 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Chilean Safety Association (ACHS)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 8 Apr 2024 (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.
The present study seeks to follow up the cohort of adults representative of Chile's 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:
- Estimate the prevalence of CP and subtypes in the general population
- Explore the association between mental health indicators, perceived work stress and presence of CP in the population.
- Investigate the impact of CP (functional, occupational and social) among the subset of participants reporting CP
- Describe the use of management strategies in those who suffer from CP.
Detailed description
- Aims of the study:
- Estimate the prevalence of chronic pain (CP) and subtypes in the
- Explore the association between mental health indicators, perceived work stress and the presence of CP in the urban population of Chile.
- Asses the functional, occupational and social impact of CP in Chile´s urban population reporting CP.
- 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:
3.1. 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) 3.2. 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) 3.3. 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
- Analysis plan:
5.1. 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 (i.e. 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 (i.e. symptoms of depression and anxiety) and for work variables (i.e. work-related stress), using logistic regression, adjusting for age, sex, physical health characteristics (aim 2).
5.2. 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 (i.e. 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 (i.e. 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Longitudinal analysis group 1 (no pain) | – | –Participants (general population residing in urban areas of Chile aged 18 years or more) not reporting chronic pain in march 2023 or march 2024 |
| Longitudinal analysis group 2 (incident chronic pain) | – | –Participants (general population residing in urban areas of Chile aged 18 years or more) not reporting chronic pain in march 2023 but reporting chronic pain in march 2024 |
| Longitudinal analysis group 3 (remitted chronic pain) | – | –Participants (general population residing in urban areas of Chile aged 18 years or more) reporting chronic pain in march 2023 but not reporting it in march 2024 |
| Longitudinal analysis group 4 (chronic pain at follow up) | – | –Participants (general population residing in urban areas of Chile aged 18 years or more) reporting chronic pain in march 2023 and march 2024 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community survey in Chile
Key inclusion criteria (2 listed)
- General population
- Residence in urban areas
Key exclusion criteria (0 listed)
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
Chronic pain (past 3 months)
Time frame: Baseline and 12-month follow-up
Participants will be asked "Have you had constant or frequent pain [most of the day] during the past 3 months?" and asked to identify the average and maximum intensity of pain in that period using a visual analogue scale (VAS) from 0 to 10. Only participants with an average pain of 4 or more will be classified as having significant chronic pain.
Depression (2 weeks)
Time frame: Baseline and 12-month follow-up
As measured by the Patient Health Questionnaire (PHQ-9). Total scores on the PHQ-9 range from 0 to 27 and higher scores indicate higher symptoms of depression.
Anxiety (2 weeks)
Time frame: Baseline and 12-month follow-up
As measured by the General Anxiety Disorder (GAD-7). Total scores on the GAD-7 range from 0 to 21 and higher scores indicate higher symptoms of anxiety.
6 secondary outcomes
Migraine Disability
Time frame: 12-month follow-up
Neuropathic Pain
Time frame: Baseline and 12-month follow-up
Fibromyalgia
Time frame: 12-month follow-up
Self harm (2 weeks)
Time frame: Baseline and 12-month follow-up
Insomnia (2 weeks)
Time frame: Baseline and 12-month follow-up
Loneliness
Time frame: Baseline and 12-month follow-up
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 12 Dec 2025.
- Individual participant dataSharing planned: Yes. The anonymized database and codebook will be made available to researcher in the Dataverse website
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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.
Antonia Errazuriz, PhD principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Migraine Disability, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 2 inclusion and 0 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 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Chronic pain (past 3 months) (time frame: Baseline and 12-month follow-up). The study lists 3 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 12 Dec 2025.