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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Chile1 site
  • Pontificia Universidad Catolica de Chile

    Santiago, RM, 7550139

Other trials in Chile

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:

  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.
Read the detailed description
  1. Aims of the study:
  2. Estimate the prevalence of chronic pain (CP) and subtypes in the
  3. Explore the association between mental health indicators, perceived work stress and the presence of CP in the urban population of Chile.
  4. Asses the functional, occupational and social impact of CP in Chile´s urban population reporting CP.
  5. 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
  1. 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).
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 groups in NCT06353100
Study groupRoleWhat 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.

  1. 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

  2. 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

  3. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted8 Apr 2024
  2. Study start1 Jan 2023
  3. Primary completion30 Apr 2025
  4. Study completion25 Sep 2025

Resources

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)
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

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.

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