An observational study in Chronic Pain, Migraine Disability and Neuropathic Pain, sponsored by Pontificia Universidad Catolica de Chile. Completed at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by Pontificia Universidad Catolica de Chile · Observational
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:
I. Aims of the study:
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:
V. Analysis plan:
5.1. Cross-sectional analysis (at follow-up)
5.2. Longitudinal analysis (baseline and follow-up)
2,928 studies on the registry are indexed under Chronic Pain; 699 are open to participants now.
This study's enrollment of 2,365 is above the median of 126 across 687 observational studies indexed under Chronic Pain.
Browse Chronic Pain studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.
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Community survey in Chile
Inclusion Criteria:
Participants (general population residing in urban areas of Chile aged 18 years or more) not reporting chronic pain in march 2023 or march 2024
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
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
Participants (general population residing in urban areas of Chile aged 18 years or more) reporting chronic pain in march 2023 and march 2024
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12-month follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12-month follow-up
Plan to share: Yes — The anonymized database and codebook will be made available to researcher in the Dataverse website
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Pontificia Universidad Catolica de Chile